Axial SpondyloarthritisRESPOND-IL17NCT05812157
Optimizing Anti-IL17 Antibody Therapy by Associating Fiber Supplementation to Correct Treatment-aggravated Gut Dysbiosis in Axial Spondyloarthritis - RESPOND-IL17
A study testing Daily dietary supplementation with Fibruline and Anti-IL-17 therapy in people with Axial Spondyloarthritis, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
Trial summary
Fiber is the main source of energy for colonic bacteria and its consumption favorably modifies the composition of the microbiota in only a few days. Their fermentation in the colon releases short-chain fatty acids (SCFAs). Clostridiales contain many strains producing SCFAs. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- Daily dietary supplementation with Fibruline and Anti-IL-17 therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 3 sitesFrance
- Study dates
- 2 Oct 2023to 23 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with spondyloarthritis meeting the ASAS criteria
- Patient considered by the treating rheumatologist for anti-IL-17 biomedication
- Patients aged between 18 and 90 years of age
- Patients who are affiliated to a French social security system or beneficiaries of such a system
- Patients with no desire to become pregnant during the study period (Effective contraception for women of childbearing age during the study period (surgical sterilization, hormonal contraceptives, barrier method, intrauterine device))
Who cannot join
- Lack of written informed consent after a time of reflection
- Patients participating in other therapeutic research or having participated in research for which the exclusion period has not ended
- Patient under court protection, guardianship or curatorship.
- Patient unable to give consent.
- Pregnant or breastfeeding woman
- Patients with digestive disorders for which a chronic inflammatory bowel disease has not been excluded
- Patients with fructose intolerance or glucose or galactose malabsorption
- Patients with known intolerance to inulin or maltodextrin
Trial locations and contacts
3 sites in 1 country.
France3 sites
Montpellier University Hospital
Montpellier, Hérault, 34000
Nîmes University Hospital
Nîmes, Gard, 30029
Tours Regional University Hospital (Bretonneau)
Tours, Indre-et-Loire, 37032
About this study
Official title: Optimization of Anti-IL17 Antibody Therapy by Associating Fiber Supplementation to Correct Treatment-aggravated Gut Dysbiosis in Axial Spondyloarthritis - RESPOND-IL17
Fiber is the main source of energy for colonic bacteria and its consumption favorably modifies the composition of the microbiota in only a few days. Their fermentation in the colon releases short-chain fatty acids (SCFAs). Clostridiales contain many strains producing SCFAs. These SCFAs can restore the intestinal barrier and promote certain anti-inflammatory cells, including regulatory T cells (Tregs), which are essential to the mechanisms in tolerance of the self. Fibers could therefore correct the intestinal abnormalities present in patients with axial spondyloarthritis (AxSpA) and aggravated by anti-IL-17 drugs and thus improve the therapeutic response to these treatments.
The hypothesis is that dietary fiber will correct the dysbiosis in AxSpA patients and increase the release of SCFAs, which favorably modulate the immune response and improve AxSpA.
Read the detailed description
Axial spondyloarthritis (AxSpA) is the second most common chronic inflammatory rheumatic disease, which develops preferentially in young subjects and results in a significant impairment of quality of life, particularly due to painful symptoms. The importance of the digestive system has long been recognized, since this disease is considered to be part of a larger group of diseases including Crohn's disease and ulcerative colitis because of their frequent association in the same patient, and because leaky gut disorders and alterations of the intestinal microbiota (dysbiosis) have been described in these patients. These abnormalities may stimulate the immune system and therefore be involved in inflammatory processes (especially Th17). The available treatments are based on non-steroidal anti-inflammatory drugs, and in the event of failure or intolerance, biomedicines targeting TNF can be used. Therapeutic monoclonal antibodies against IL-17 have recently enriched the therapeutic arsenal. Although most anti-TNF agents have a beneficial effect on the rheumatologic and digestive aspects of these diseases, anti-IL-17 agents are not expected to be effective in inflammatory bowel diseases.
Indeed, a deleterious role of anti-IL-17 on the intestinal microbiota has even been demonstrated, which could result in a reduction of the systemic anti-inflammatory effect expected from these molecules, and consequently of the clinical benefit felt by the patient. In fact, anti-IL-17s lead to a significant decrease in Clostridiales, bacteria that participate in intestinal homeostasis.
Fiber is the main source of energy for colonic bacteria and its consumption favorably modifies the composition of the microbiota in just a few days. Their fermentation in the colon releases short-chain fatty acids (SCFAs). Clostridiales contain many strains producing SCFAs. These SCFAs can restore the intestinal barrier and promote certain anti-inflammatory cells, including regulatory T cells (Tregs), which are essential to the mechanisms in tolerance of the self. Fibers could therefore correct the intestinal abnormalities present in AxSpA patients and aggravated by anti-IL-17 drugs and thus improve the therapeutic response to these treatments.
The hypothesis is therefore that dietary fiber will correct the dysbiosis in AxSpA patients and increase the release of SCFAs, which favorably modulate the immune response and thus improve AxSpA.
- Conditions
- Axial Spondyloarthritis
- Being tested
- Daily dietary supplementation with Fibruline, Anti-IL-17 therapy
- Keywords
- dysbiosis, short-chain fatty acids, fiber, microbiota
- Medical subject headings
- Axial Spondyloarthritis, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily dietary supplementation with FibrulineDietary supplement
Supplementation with 12 grams per day of Fibruline reconstituted with 60mL of water, once a day
Anti-IL-17 therapyDrug
Patients in both groups will be on anti-IL-17 therapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients with aSp receiving fiber supplements in the form of Fibruline® Instant (Fagron laboratories) Receives: Dietary Supplement: Daily dietary supplementation with Fibruline; Drug: Anti-IL-17 therapy |
| Control group | Placebo comparator | Patients with aSp receiving fake fiber supplements (placebo) in the form of Maltodextrine (laboratoire Fagron). Receives: Dietary Supplement: Daily dietary supplementation with Fibruline; Drug: Anti-IL-17 therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clostridial changes in the Experimental group
Patients will receive fiber supplementation with inulin (Fibruline® Instant, Fagron laboratory) at a rate of 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. To confirm the efficacy of treatment, the percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.
Measured: Week 0
Clostridial changes in Controls
Patients will receive a placebo consisting of Maltodextrin (Fagron laboratories), packaged in jars identical to those used for inulin, with a volumetric equivalent, an energy contribution and very similar color. Patients will consume 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. The percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.
Measured: Week 0
Clostridial changes in the Experimental group
Patients will receive fiber supplementation with inulin (Fibruline® Instant, Fagron laboratory) at a rate of 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. To confirm the efficacy of treatment, the percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.
Measured: Week 12
Clostridial changes in Controls
Patients will receive a placebo consisting of Maltodextrin (Fagron laboratories), packaged in jars identical to those used for inulin, with a volumetric equivalent, an energy contribution and very similar color. Patients will consume 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. The percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.
Measured: Week 12
Secondary outcomes (92)
Effect of fiber supplementation on clinical therapeutic response in the experimental group: Delta BASDAI
Clinical response rates observed in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.
The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) will be used to measure the percentage of patients responding positively to treatment.
Measured: Week 0
Effect of fiber supplementation on clinical therapeutic response in the experimental group: Delta BASDAI
Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.
The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) will be used to measure the percentage of patients responding positively to treatment.
Measured: Week 12
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS20
Clinical response rates observed in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.
The ASAS20 will be used to measure the percentage of patients responding positively to treatment. This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 20) is defined as an improvement in at least 20% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Measured: Week 0
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS20
Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.
The ASAS20 will be used to measure the percentage of patients responding positively to treatment. This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 20) is defined as an improvement in at least 20% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Measured: Week 12
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS40
Clinical response rates observed in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.
The ASAS40 will be used to measure the percentage of patients responding positively to treatment. This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 40) is defined as an improvement in at least 40% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Measured: Week 0
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS40
Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.
The ASAS40 will be used to measure the percentage of patients responding positively to treatment. This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 40) is defined as an improvement in at least 40% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Measured: Week 12
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASDAS
Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.
The ASDAS (Ankylosing Spondylitis Disease Activity Score) will be used to measure the percentage of patients responding positively to treatment. This tool is an index to assess disease activity in Ankylosing Spondylitis. The preferred score uses CRP (C-reactive protein) rather than ESR (erythrocyte sedimentation rate).
Measured: Week 0
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASDAS
Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.
The ASDAS (Ankylosing Spondylitis Disease Activity Score) will be used to measure the percentage of patients responding positively to treatment. This tool is an index to assess disease activity in Ankylosing Spondylitis. The preferred score uses CRP (C-reactive protein) rather than ESR (erythrocyte sedimentation rate).
Measured: Week 12
Effect of fiber supplementation on clinical therapeutic response: GIQLI
Clinical response rates in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.
Digestive symptoms will be assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire at Week 0 and Week 12. The GIQLI is a measure of the subjective perception of well-being by a patient, which may vary unexpectedly between diagnostic groups. The GIQLI was initiated in Germany and includes 36 items asking about symptoms, physical status, emotions, social dysfunction, and effects of medical treatment. The Questions cover the following 5 dimensions : symptoms, physical condition, emotions, social integration and medical treatment.
Measured: Week 0
Effect of fiber supplmentation on clinical therapeutic response: GIQLI
Clinical response rates observed at 3 months in patients treated with anti-IL-17 with fiber supplementation will be recorded as a percentage.
Digestive symptoms will be assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire at Week 0 and Week 12. The GIQLI is a measure of the subjective perception of well-being by a patient, which may vary unexpectedly between diagnostic groups. The GIQLI was initiated in Germany and includes 36 items asking about symptoms, physical status, emotions, social dysfunction, and effects of medical treatment. The Questions cover the following 5 dimensions : symptoms, physical condition, emotions, social integration and medical treatment.
Measured: Week 12
Effect at 12 weeks of placebo on clinical therapeutic response: Delta BASDAI
Clinical response rates observed in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage.
The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) will be used to measure the percentage of patients responding positively to treatment.
Measured: Week 0
Effect at 12 weeks of placebo on clinical therapeutic response: Delta BASDAI
Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage.
The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) will be used to measure the percentage of patients responding positively to treatment.
Measured: Week 12
Effect at 12 weeks of placebo on clinical therapeutic response: ASA20
Clinical response rates observed in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage.
The ASAS20 will be used to measure the percentage of patients responding positively to treatment.This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 20) is defined as an improvement in at least 20% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Measured: Week 0
Effect at 12 weeks of placebo on clinical therapeutic response: ASA20
Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage.
The ASAS20 will be used to measure the percentage of patients responding positively to treatment.This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 20) is defined as an improvement in at least 20% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Measured: Week 12
Effect at 12 weeks of placebo on clinical therapeutic response: ASA40
Clinical response rates observed in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage.
The ASAS40 will be used to measure the percentage of patients responding positively to treatment.This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 40) is defined as an improvement in at least 40% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Measured: Week 0
Effect at 12 weeks of placebo on clinical therapeutic response: ASA40
Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage.
The ASAS40 will be used to measure the percentage of patients responding positively to treatment.This tool was developed by the Assessment of SpondylArthritis international Society (ASAS). The ASAS Response Criteria (ASAS 40) is defined as an improvement in at least 40% and an absolute improvement in at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation (last 2 questions of BASDAI).
Measured: Week 12
Effect at 12 weeks of placebo on clinical therapeutic response: ASDAS
Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The ASDAS (Ankylosing Spondylitis Disease Activity Score) will be used to measure the percentage of patients responding positively to treatment. This tool is an index to assess disease activity in Ankylosing Spondylitis. The preferred score uses CRP (C-reactive protein) rather than ESR (erythrocyte sedimentation rate).
Measured: Week 0
Effect at 12 weeks of placebo on clinical therapeutic response: ASDAS
Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage. The ASDAS (Ankylosing Spondylitis Disease Activity Score) will be used to measure the percentage of patients responding positively to treatment. This tool is an index to assess disease activity in Ankylosing Spondylitis. The preferred score uses CRP (C-reactive protein) rather than ESR (erythrocyte sedimentation rate).
Measured: Week 12
Effect of placebo on clinical therapeutic response: GIQLI
Clinical response rates observed in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage.
Digestive symptoms will be assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire at Week 0 and Week 12. The GIQLI is a measure of the subjective perception of well-being by a patient, which may vary unexpectedly between diagnostic groups. The GIQLI was initiated in Germany and includes 36 items asking about symptoms, physical status, emotions, social dysfunction, and effects of medical treatment. The Questions cover the following 5 dimensions : symptoms, physical condition, emotions, social integration and medical treatment.
Measured: Week 0
Effect of placebo on clinical therapeutic response: GIQLI
Clinical response rates observed at 3 months in patients treated with anti-IL-17 without fiber supplementation will be recorded as a percentage.
Digestive symptoms will be assessed using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire at Week 0 and Week 12. The GIQLI is a measure of the subjective perception of well-being by a patient, which may vary unexpectedly between diagnostic groups. The GIQLI was initiated in Germany and includes 36 items asking about symptoms, physical status, emotions, social dysfunction, and effects of medical treatment. The Questions cover the following 5 dimensions : symptoms, physical condition, emotions, social integration and medical treatment.
Measured: Week 12
Tolerance of anti-IL17 intervention and treatment in the experimental group: Permeability
Changes in serum concentrations of intestinal permeability markers (zonulin, claudin-3, iFABP); and endotoxemia (LBP, CD14s) will be measured by ELISA in ng/ml
Measured: Month 0
Tolerance of anti-IL17 intervention and treatment in controls: Permeability
Changes in serum concentrations of intestinal permeability markers (zonulin, claudin-3, iFABP); and endotoxemia (LBP, CD14s) will be measured by ELISA in ng/ml
Measured: Month 3
Tolerance of anti-IL17 intervention and treatment in the experimental group
The distribution and diversity of different germs will be measured by 16S RNA sequencing.
Quantitative
Measured: Month 3
Tolerance of anti-IL17 intervention and treatment in controls
The distribution and diversity of different germs will be measured by 16S RNA sequencing.
Quantitative
Measured: Month 3
Presence of candida in patients in the experimental group
YES/NO
Measured: Month 3
Presence of candida in patients in the control group
YES/NO
Measured: Month 3
Tolerance of treatment in the experimental group
All adverse events related or not to anti-IL17 treatment and potentially associated with the consumption of high doses of fiber (bloating, flatulence, diarrhea, abdominal pain) will be recorded
Measured: Month 3
Tolerance of treatment in the control group
All adverse events related or not to anti-IL17 treatment and potentially associated with the consumption of high doses of fiber (bloating, flatulence, diarrhea, abdominal pain) will be recorded
Measured: Month 3
Complete blood count: Red blood cells in the experimental group
Red blood cells will be measured in millions/mm3
Measured: Month 0
Complete blood count: Red blood cells in the control group
Red blood cells will be measured in millions/mm3
Measured: Month 0
Complete blood count: Red blood cells in the experimental group
Red blood cells will be measured in millions/mm3
Measured: Month 3
Complete blood count: Red blood cells in the control group
Red blood cells will be measured in millions/mm3
Measured: Month 3
Complete blood count: White blood cells in the experimental group
White blood cells will be measured in millions/mm3
Measured: Month 0
Complete blood count: White blood cells in the control group
White blood cells will be measured in millions/mm3
Measured: Month 0
Complete blood count: White blood cells in the experimental group
White blood cells will be measured in millions/mm3
Measured: Month 3
Complete blood count: White blood cells in the control group
White blood cells will be measured in millions/mm3
Measured: Month 3
Complete blood count: Hemoglobin in the experimental group
Hemoglobin will be measured in g/L
Measured: Month 0
Complete blood count: Hemoglobin in the control group
Hemoglobin will be measured in g/L
Measured: Month 0
Complete blood count: Hemoglobin in the experimental group
Hemoglobin will be measured in g/L
Measured: Month 3
Complete blood count: Hemoglobin in the control group
Hemoglobin will be measured in g/L
Measured: Month 3
Complete blood count: Hematocrit in the experimental group
Hematocrit will be measured as a % of whole blood
Measured: Month 0
Complete blood count: Hematocrit in the control group
Hematocrit will be measured as a % of whole blood
Measured: Month 0
Complete blood count: Hematocrit in the experimental group
Hematocrit will be measured as a % of whole blood
Measured: Month 3
Complete blood count: Hematocrit in the control group
Hematocrit will be measured as a % of whole blood
Measured: Month 3
Complete blood count: Platelets in the experimental group
Platelets will be measured in K/µL
Measured: Month 0
Complete blood count: Platelets in the control group
Platelets will be measured in K/µL
Measured: Month 0
Complete blood count: Platelets in the experimental group
Platelets will be measured in K/µL
Measured: Month 3
Complete blood count: Platelets in the control group
Platelets will be measured in K/µL
Measured: Month 3
T-lymphocytes in the experimental group
The phenotype of T-lymphocytes (Treg, Thelpers) will be measured as % of total white blood cells
Measured: Month 0
T-lymphocytes in the control group
The phenotype of T-lymphocytes (Treg, Thelpers) will be measured as % of total white blood cells
Measured: Month 0
T-lymphocytes in the experimental group
The phenotype of T-lymphocytes (Treg, Thelpers) will be measured as % of total white blood cells
Measured: Month 3
T-lymphocytes in the control group
The phenotype of T-lymphocytes (Treg, Thelpers) will be measured as % of total white blood cells
Measured: Month 3
Monocytes in the experimental group
Monocytes will be measured by flow cytometry (CD25, CD127, CXCR3, CCR6, CD294, CD14, CD16, TNF, IL-6) as % of total white blood cells
Measured: Month 0
Monocytes in the control group
Monocytes will be measured by flow cytometry (CD25, CD127, CXCR3, CCR6, CD294, CD14, CD16, TNF, IL-6) as % of total white blood cells
Measured: Month 0
Monocytes in the experimental group
Monocytes will be measured by flow cytometry (CD25, CD127, CXCR3, CCR6, CD294, CD14, CD16, TNF, IL-6) as % of total white blood cells
Measured: Month 3
Monocytes in the control group
Monocytes will be measured by flow cytometry (CD25, CD127, CXCR3, CCR6, CD294, CD14, CD16, TNF, IL-6) as % of total white blood cells
Measured: Month 3
Aspartate aminotransferase (ASAT) in the experimental group
Aspartate aminotransferase (or ASAT) will be measured in international units per liter
Measured: Month 0
Aspartate aminotransferase (ASAT) in the experimental group
Aspartate aminotransferase (or ASAT) will be measured in international units per liter
Measured: Month 3
Aspartate aminotransferase (ASAT) in the control group
Aspartate aminotransferase (or ASAT) will be measured in international units per liter
Measured: Month 0
Aspartate aminotransferase (ASAT) in the control group
Aspartate aminotransferase (or ASAT) will be measured in international units per liter
Measured: Month 3
Alanine aminotransferase (ALAT) in the experimental group
Alanine aminotransferase (ALAT) will be measured in international units per liter
Measured: Month 0
Alanine aminotransferase (ALAT) in the experimental group
Alanine aminotransferase (ALAT) will be measured in international units per liter
Measured: Month 3
Alanine aminotransferase (ALAT) in the control group
Alanine aminotransferase (ALAT) will be measured in international units per liter
Measured: Month 0
Alanine aminotransferase (ALAT) in the control group
Alanine aminotransferase (ALAT) will be measured in international units per liter
Measured: Month 3
Alkaline phosphatase in the experimental group
Alkaline phosphatase (ALP) will be measured in units per liter
Measured: Month 0
Alkaline phosphatase in the experimental group
Alkaline phosphatase (ALP) will be measured in units per liter
Measured: Month 3
Alkaline phosphatase in the control group
Alkaline phosphatase (ALP) will be measured in units per liter
Measured: Month 0
Alkaline phosphatase in the control group
Alkaline phosphatase (ALP) will be measured in units per liter
Measured: Month 3
Calcium in the experimental group
Calcium will be measured in mmol/L
Measured: Month 0
Calcium in the experimental group
Calcium will be measured in mmol/L
Measured: Month 3
Calcium in the control group
Calcium will be measured in mmol/L
Measured: Month 0
Calcium in the control group
Calcium will be measured in mmol/L
Measured: Month 3
Creatinine in the experimental group
Calcium will be measured in μmol/L
Measured: Month 0
Creatinine in the experimental group
Calcium will be measured in μmol/L
Measured: Month 12
Creatinine in the control group
Calcium will be measured in μmol/L
Measured: Month 0
Creatinine in the control group
Calcium will be measured in μmol/L
Measured: Month 12
Albumin in the experimental group
Albumin will be measured in g/liter
Measured: Month 0
Albumin in the experimental group
Albumin will be measured in g/liter
Measured: Month 12
Albumin in the control group
Albumin will be measured in g/liter
Measured: Month 0
Albumin in the control group
Albumin will be measured in g/liter
Measured: Month 12
Urea in the experimental group
Urea will be measured in mmol/L
Measured: Month 0
Urea in the experimental group
Urea will be measured in mmol/L
Measured: Month 12
Urea in the control group
Urea will be measured in mmol/L
Measured: Month 0
Urea in the control group
Urea will be measured in mmol/L
Measured: Month 12
Bilirubin in the experimental group
Bilirubin will be measured in µmol/L
Measured: Month 0
Bilirubin in the experimental group
Bilirubin will be measured in µmol/L
Measured: Month 12
Bilirubin in the control group
Bilirubin will be measured in µmol/L
Measured: Month 0
Bilirubin in the control group
Bilirubin will be measured in µmol/L
Measured: Month 12
C-Reactive Protein in the experimental group
C-Reactive Protein will be measured in mg/L
Measured: Month 0
C-Reactive Protein in the experimental group
C-Reactive Protein will be measured in mg/L
Measured: Month 12
C-Reactive Protein in the control group
C-Reactive Protein will be measured in mg/L
Measured: Month 0
C-Reactive Protein in the control group
C-Reactive Protein will be measured in mg/L
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start2 Oct 2023
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, double-blind, prospective, randomized controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cédric LUKAS, Professor, Study director, University Hospital, MontpellierJacques MOREL, Professor, Principal investigator, University Hospital, MontpellierClaire DAIEN, Professor, Principal investigator, University Hospital, MontpellierGaël MOUTERDE, Doctor, Principal investigator, University Hospital, MontpellierCécile GAUJOUX-VIALA, Professor, Principal investigator, Nîmes University HospitalDenis MULLEMAN, Professor, Principal investigator, Tours University HospitalGuillermo CARVAJAL, Doctor, Principal investigator, Tours University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812157
- Sponsor's protocol ID
- IDRCB : 2022-A00135-38
- Acronym
- RESPOND-IL17
- Status last verified
- May 2026
- First submitted
- 31 Mar 2023
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Anti-IL17 Antibody Therapy by Associating Fiber Supplementation to Correct Treatment-aggravated Gut Dysbiosis in Axial Spondyloarthritis - RESPOND-IL17
- ClinicalTrials.gov ID
- NCT05812157
- Acronym / sponsor ID
- RESPOND-IL17 / IDRCB : 2022-A00135-38
- Conditions
- Axial Spondyloarthritis
- Keywords
- dysbiosis, short-chain fatty acids, fiber, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fiber is the main source of energy for colonic bacteria and its consumption favorably modifies the composition of the microbiota in only a few days. Their fermentation in the colon releases short-chain fatty acids (SCFAs). Clostridiales contain many strains producing SCFAs. These SCFAs can restore the intestinal barrier and promote certain anti-inflammatory cells, including regulatory T cells (Tregs), which are essential to the mechanisms in tolerance of the self. Fibers could therefore correct the intestinal abnormalities present in patients with axial spondyloarthritis (AxSpA) and aggravated by anti-IL-17 drugs and thus improve the therapeutic response to these treatments.
The hypothesis is that dietary fiber will correct the dysbiosis in AxSpA patients and increase the release of SCFAs, which favorably modulate the immune response and improve AxSpA.
Detailed description
Axial spondyloarthritis (AxSpA) is the second most common chronic inflammatory rheumatic disease, which develops preferentially in young subjects and results in a significant impairment of quality of life, particularly due to painful symptoms. The importance of the digestive system has long been recognized, since this disease is considered to be part of a larger group of diseases including Crohn's disease and ulcerative colitis because of their frequent association in the same patient, and because leaky gut disorders and alterations of the intestinal microbiota (dysbiosis) have been described in these patients. These abnormalities may stimulate the immune system and therefore be involved in inflammatory processes (especially Th17). The available treatments are based on non-steroidal anti-inflammatory drugs, and in the event of failure or intolerance, biomedicines targeting TNF can be used. Therapeutic monoclonal antibodies against IL-17 have recently enriched the therapeutic arsenal. Although most anti-TNF agents have a beneficial effect on the rheumatologic and digestive aspects of these diseases, anti-IL-17 agents are not expected to be effective in inflammatory bowel diseases.
Indeed, a deleterious role of anti-IL-17 on the intestinal microbiota has even been demonstrated, which could result in a reduction of the systemic anti-inflammatory effect expected from these molecules, and consequently of the clinical benefit felt by the patient. In fact, anti-IL-17s lead to a significant decrease in Clostridiales, bacteria that participate in intestinal homeostasis.
Fiber is the main source of energy for colonic bacteria and its consumption favorably modifies the composition of the microbiota in just a few days. Their fermentation in the colon releases short-chain fatty acids (SCFAs). Clostridiales contain many strains producing SCFAs. These SCFAs can restore the intestinal barrier and promote certain anti-inflammatory cells, including regulatory T cells (Tregs), which are essential to the mechanisms in tolerance of the self. Fibers could therefore correct the intestinal abnormalities present in AxSpA patients and aggravated by anti-IL-17 drugs and thus improve the therapeutic response to these treatments.
The hypothesis is therefore that dietary fiber will correct the dysbiosis in AxSpA patients and increase the release of SCFAs, which favorably modulate the immune response and thus improve AxSpA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, double-blind, prospective, randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: Daily dietary supplementation with Fibruline, Drug: Anti-IL-17 therapyPatients with aSp receiving fiber supplements in the form of Fibruline® Instant (Fagron laboratories) |
| Control group | Placebo comparator | Dietary Supplement: Daily dietary supplementation with Fibruline, Drug: Anti-IL-17 therapyPatients with aSp receiving fake fiber supplements (placebo) in the form of Maltodextrine (laboratoire Fagron). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with spondyloarthritis meeting the ASAS criteria
- Patient considered by the treating rheumatologist for anti-IL-17 biomedication
- Patients aged between 18 and 90 years of age
- Patients who are affiliated to a French social security system or beneficiaries of such a system
- Patients with no desire to become pregnant during the study period (Effective contraception for women of childbearing age during the study period (surgical sterilization, hormonal contraceptives, barrier method, intrauterine device))
Key exclusion criteria (8 listed)
- Lack of written informed consent after a time of reflection
- Patients participating in other therapeutic research or having participated in research for which the exclusion period has not ended
- Patient under court protection, guardianship or curatorship.
- Patient unable to give consent.
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily dietary supplementation with FibrulineSupplementation with 12 grams per day of Fibruline reconstituted with 60mL of water, once a day | Dietary supplement | Control group, Experimental group |
| Anti-IL-17 therapyPatients in both groups will be on anti-IL-17 therapy | Drug | Control group, Experimental group |
Primary outcome
Clostridial changes in the Experimental group
Time frame: Week 0
Patients will receive fiber supplementation with inulin (Fibruline® Instant, Fagron laboratory) at a rate of 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. To confirm the efficacy of treatment, the percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.
Clostridial changes in Controls
Time frame: Week 0
Patients will receive a placebo consisting of Maltodextrin (Fagron laboratories), packaged in jars identical to those used for inulin, with a volumetric equivalent, an energy contribution and very similar color. Patients will consume 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. The percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.
Clostridial changes in the Experimental group
Time frame: Week 12
Patients will receive fiber supplementation with inulin (Fibruline® Instant, Fagron laboratory) at a rate of 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. To confirm the efficacy of treatment, the percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.
Clostridial changes in Controls
Time frame: Week 12
Patients will receive a placebo consisting of Maltodextrin (Fagron laboratories), packaged in jars identical to those used for inulin, with a volumetric equivalent, an energy contribution and very similar color. Patients will consume 12 grams of powder per day reconstituted with approximately 60mL of water and consumed in one intake per day. The percentage of patients with a >10% decrease in Clostriadiales in their stools at 3 months after initiation of anti-IL-17 will be recorded. This percentage will be based on the distribution of bacteria analyzed by 16S RNA sequencing.
92 secondary outcomes
Effect of fiber supplementation on clinical therapeutic response in the experimental group: Delta BASDAI
Time frame: Week 0
Effect of fiber supplementation on clinical therapeutic response in the experimental group: Delta BASDAI
Time frame: Week 12
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS20
Time frame: Week 0
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS20
Time frame: Week 12
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS40
Time frame: Week 0
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASAS40
Time frame: Week 12
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASDAS
Time frame: Week 0
Effect of fiber supplementation on clinical therapeutic response in the experimental group: ASDAS
Time frame: Week 12
Effect of fiber supplementation on clinical therapeutic response: GIQLI
Time frame: Week 0
Effect of fiber supplmentation on clinical therapeutic response: GIQLI
Time frame: Week 12
Effect at 12 weeks of placebo on clinical therapeutic response: Delta BASDAI
Time frame: Week 0
Effect at 12 weeks of placebo on clinical therapeutic response: Delta BASDAI
Time frame: Week 12
Effect at 12 weeks of placebo on clinical therapeutic response: ASA20
Time frame: Week 0
Effect at 12 weeks of placebo on clinical therapeutic response: ASA20
Time frame: Week 12
Effect at 12 weeks of placebo on clinical therapeutic response: ASA40
Time frame: Week 0
Effect at 12 weeks of placebo on clinical therapeutic response: ASA40
Time frame: Week 12
Effect at 12 weeks of placebo on clinical therapeutic response: ASDAS
Time frame: Week 0
Effect at 12 weeks of placebo on clinical therapeutic response: ASDAS
Time frame: Week 12
Effect of placebo on clinical therapeutic response: GIQLI
Time frame: Week 0
Effect of placebo on clinical therapeutic response: GIQLI
Time frame: Week 12
Tolerance of anti-IL17 intervention and treatment in the experimental group: Permeability
Time frame: Month 0
Tolerance of anti-IL17 intervention and treatment in controls: Permeability
Time frame: Month 3
Tolerance of anti-IL17 intervention and treatment in the experimental group
Time frame: Month 3
Tolerance of anti-IL17 intervention and treatment in controls
Time frame: Month 3
Presence of candida in patients in the experimental group
Time frame: Month 3
Presence of candida in patients in the control group
Time frame: Month 3
Tolerance of treatment in the experimental group
Time frame: Month 3
Tolerance of treatment in the control group
Time frame: Month 3
Complete blood count: Red blood cells in the experimental group
Time frame: Month 0
Complete blood count: Red blood cells in the control group
Time frame: Month 0
Complete blood count: Red blood cells in the experimental group
Time frame: Month 3
Complete blood count: Red blood cells in the control group
Time frame: Month 3
Complete blood count: White blood cells in the experimental group
Time frame: Month 0
Complete blood count: White blood cells in the control group
Time frame: Month 0
Complete blood count: White blood cells in the experimental group
Time frame: Month 3
Complete blood count: White blood cells in the control group
Time frame: Month 3
Complete blood count: Hemoglobin in the experimental group
Time frame: Month 0
Complete blood count: Hemoglobin in the control group
Time frame: Month 0
Complete blood count: Hemoglobin in the experimental group
Time frame: Month 3
Complete blood count: Hemoglobin in the control group
Time frame: Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cédric LUKAS, Professor study director
University Hospital, Montpellier
Jacques MOREL, Professor principal investigator
University Hospital, Montpellier
Claire DAIEN, Professor principal investigator
University Hospital, Montpellier
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily dietary supplementation with Fibruline and Anti-IL-17 therapy in people with Axial Spondyloarthritis, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clostridial changes in the Experimental group (time frame: Week 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.