Ankylosing SpondylitisEarly Phase 1ASGUTNCT03726645
The Effect of Fecal Microbiota Transplantation in Ankylosing Spondylitis (AS) Patients.
A Early Phase 1 study testing Fecal microbiota transplantation in people with Ankylosing Spondylitis, run by Hospital District of Helsinki and Uusimaa at 1 site in Finland.
Trial summary
Ankylosing spondylitis (AS) patients often have subclinical gut wall inflammation. Gut dysbiosis has been associated with both AS and Crohn disease, both of which have several features in common. Gut dysbiosis is associated with specific microbial profile in AS patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Fecal microbiota transplantation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 24 Oct 2018to Apr 2020
- Phase
- Early Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of AS by either the 1984 New York criteria or the ASAS (Assessment of SpondyloArthritis International Society) criteria for axial spondyloarthritis.
- Active disease measured by BASDAI > 4.
- Availability of consecutive fecal samples over 1 year period.
- Compliance to attend ileocolonoscopy and FMT procedure.
Who cannot join
- Diagnosis of inflammatory bowel disease.
- Antibiotic therapy within the last 3 months.
- Use of any probiotics within the last 3 months.
- Pregnancy.
- Unability to provide a written consent.
- Other reason which by the opinion of the investigator makes patient ineligible for the study.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Hospital District of Helsinki and Uusimaa, Department of Rheumatology
Helsinki, Uusimaa, 00029
About this study
Official title: The Role of Gut Microbiota in the Pathogenesis of Ankylosing Spondylitis (AS), and the Effect of Fecal Microbiota Transplantation on Gut Microbiota, Gut Wall Inflammation and Clinical Activity of AS
Ankylosing spondylitis (AS) patients often have subclinical gut wall inflammation. Gut dysbiosis has been associated with both AS and Crohn disease, both of which have several features in common. Gut dysbiosis is associated with specific microbial profile in AS patients. Fecal microbiota transplantation (FMT) has been proved to be safe and effective treatment for recurrent Clostridium difficile infection, and the change in gut microbiota is shown to be long lasting. It has led to interest to study its effect on different inflammatory conditions associated with gut dysbiosis.
We hypothesize that dysbiosis in AS leads to inflammasome overactivation on gut mucosa. We aim to study the role of gut inflammation, gut microbiota and inflammasome activation in pathogenesis of AS, and the effect of FMT on these factors, as well as clinical activity, in AS patients.
Read the detailed description
This is a double-blind placebo- controlled randomized pilot study with 20 patients with active AS from 2 Finnish outpatient clinics. An ileocolonoscopy will be performed to all patients. 10 patients will receive FMT with feces of one of two healthy donors, and 10 patients with their own feces during ileocolonoscopy. Ileal and colonic biopsies will be taken to assess gut wall inflammation and mucosal microbiota composition. Ileocolonoscopy will be controlled in 6 months in patients with macroscopic inflammatory lesions in the first colonoscopy. From mucosal biopsies we will assess intestinal mucosal structure, inflammasome activity, cytokine expression, and the mucin layer thickness and the amount of bacterial LPS (lipopolysaccharide), which are associated with mucosal integrity. Blood levels of zonulin and LPS as indicators of mucosal permeability and bacterial penetrance will be assessed. Fecal samples will be collected repeatedly to measure fecal calprotectin, and to assess the bacterial profile changes. From mucosal biopsies and fecal samples microbial DNA will be segregated and bacterial species sorted by rRNA- based sequence technique. Clinical activity of AS will be assessed in follow-up visits as well as repeated BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), BASFI (Bath Ankylosing Spondylitis Functional Index) and MASES (Maastricht Ankylosing Spondylitis Enthesitis Score) evaluations, and measurement of CRP (C-reactive protein) and ESR (erythrocyte sedimentation rate). Follow-up time is 12 months.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Fecal microbiota transplantation
- Keywords
- ankylosing spondylitis, fecal microbiota transplantation, intestinal mucosal immunity, dysbiosis, microbiome
- Medical subject headings
- Spondylitis, Ankylosing, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantationOther
Fecal microbiota transplantation
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | Allogeneic fecal microbiota transplantation (from donor) Receives: Other: Fecal microbiota transplantation |
| Control group | Placebo comparator | Autologous fecal microbiota transplantation (own stool) Receives: Other: Fecal microbiota transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of FMT (fecal microbiota transplantation) on the clinical activity of ankylosing spondylitis (AS) as assessed by change in BASDAI (Bath Ankylosing Spondylitis Disease Activity Index).
BASDAI scale 0-10 (the higher the score the more severe the symptoms). Decrease in BASDAI indicates positive outcome.
Measured: 5 measurements within 12 months
Secondary outcomes (17)
The effect of FMT on the clinical activity of AS as assessed by change in BASFI (Bath Ankylosing Spondylitis Functional Index).
BASFI scale 0-10 (the higher the score the more severe the symptoms). Decrease in BASFI indicates positive outcome.
Measured: 5 measurements within 12 months.
The effect of FMT on the clinical activity of AS as assessed by change in MASES (Maastricht Ankylosing Spondylitis Enthesitis Score).
MASES scale 0-13 (the higher the score the more severe the symptoms). Decrease in MASES indicates positive outcome.
Measured: 5 measurements within 12 months.
The effect of FMT on C-reactive protein (CRP) concentration.
Change in inflammatory parameter CRP concentration indicates positive outcome.
Measured: 7 measurements within 12 months.
The effect of FMT on erythrocyte sedimentation rate (ESR) level.
Change in inflammatory parameter ESR level indicates positive outcome.
Measured: 7 measurements within 12 months.
The effect of FMT on gut wall inflammation as assessed by change in fecal calprotectin (F-calpro) level.
Change in fecal calprotectin level indicates positive outcome.
Measured: 7 measurements within 12 months.
The effect of FMT on gut microbiota composition in AS patients.
Change in gut microbiota composition evaluated by stool microbial analysis indicates positive outcome.
Measured: 7 stool microbial analysis within 12 months.
Association between specific intestinal pathogens and disease activity as assessed by BASDAI score.
BASDAI scale 0-10 (the higher the score the more severe the symptoms). Association between specific microbial profile and higher or lower disease activity assessed by BASDAI indicates a positive outcome.
Measured: 7 stool microbial samples and 5 BASDAI measurements within 12 months.
Association between specific intestinal pathogens and disease activity as assessed by CRP concentration.
Association between specific intestinal pathogens and (higher or lower) CRP concentration compared to patients with different microbial profile indicates a positive outcome.
Measured: 7 stool microbial samples and 7 CRP measurements within 12 months.
Association between gut wall cytokine expression and disease activity as assessed by BASDAI score.
BASDAI scale 0-10 (the higher the score the more severe the symptoms). Association between the level of cytokine expression and BASDAI score indicates a positive outcome.
Measured: Intestinal biopsies at baseline.
Association between gut wall inflammasome activity and disease activity as assessed by BASDAI score.
BASDAI scale 0-10 (the higher the score the more severe the symptoms). Association between gut wall inflammation as assessed by inflammasome activity and disease activity as assessed by BASDAI score indicates a positive outcome.
Measured: Intestinal biopsies at baseline.
Association between gut wall cytokine expression and disease activity as assessed by CRP concentration.
Association between gut wall inflammation as assessed by the level of cytokine expression and the disease activity as assessed by CRP concentration indicates a positive outcome.
Measured: Intestinal biopsies at baseline.
Association between gut wall inflammasome activity and disease activity as assessed by CRP concentration.
Association between gut wall inflammation as assessed by inflammasome activity and disease activity as assessed by CRP concentration indicates a positive outcome.
Measured: Intestinal biopsies at baseline.
Association between F-Calpro level and disease activity as assessed by BASDAI score.
Calprotectin- level < 100 ug/l is considered as normal. BASDAI scale 0-10 (the higher the score the more severe the symptoms). Association between gut wall inflammation as assessed by F-Calpro level and disease activity as assessed by BASDAI score indicates a positive outcome.
Measured: 7 F-Calpro- measurements and 5 BASDAI measurements within 12 months.
Association between F-Calpro level and disease activity as assessed by CRP concentration.
Calprotectin- level < 100 ug/l is considered as normal. Association between gut wall inflammation as assessed by F-Calpro and disease activity as assessed by CRP concentration indicates a positive outcome.
Measured: 7 F-Calpro and CRP measurements within 12 months.
The effect of FMT on gut wall permeability as assessed by blood zonulin concentration.
Change in zonulin concentration indicates a positive outcome.
Measured: 5 measurements within 12 months.
The effect of FMT on gut wall bacterial penetrance as assessed by lipopolysaccharide (LPS) concentration.
Change in LPS concentration indicates a positive outcome.
Measured: 5 measurements within 12 months.
The effect of FMT on gastrointestinal symptoms as assessed by GSRS (The Gastrointestinal Symptom Rating Scale).
GSRS score scale 15-105. The higher the score the more severe the symptoms. Decrease in GSRS indicates a positive outcome.
Measured: 5 GSRS evaluations within 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start24 Oct 2018
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital District of Helsinki and Uusimaa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johanna Hiltunen, Hospital District of Helsinki and Uusimaa
- Investigators
- Kari K Eklund, PhD, MD, Study director, Hospital District of Helsinki and Uusimaa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726645
- Sponsor's protocol ID
- HospitalDHU/Rheumatology
- Acronym
- ASGUT
- Status last verified
- May 2019
- First submitted
- 23 Mar 2018
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Anderson JL, Edney RJ, Whelan K. Systematic review: faecal microbiota transplantation in the management of inflammatory bowel disease. Aliment Pharmacol Ther. 2012 Sep;36(6):503-16. doi: 10.1111/j.1365-2036.2012.05220.x. Epub 2012 Jul 25.
PubMed 22827693Breban M, Tap J, Leboime A, Said-Nahal R, Langella P, Chiocchia G, Furet JP, Sokol H. Faecal microbiota study reveals specific dysbiosis in spondyloarthritis. Ann Rheum Dis. 2017 Sep;76(9):1614-1622. doi: 10.1136/annrheumdis-2016-211064. Epub 2017 Jun 12.
PubMed 28606969Ciccia F, Bombardieri M, Principato A, Giardina A, Tripodo C, Porcasi R, Peralta S, Franco V, Giardina E, Craxi A, Pitzalis C, Triolo G. Overexpression of interleukin-23, but not interleukin-17, as an immunologic signature of subclinical intestinal inflammation in ankylosing spondylitis. Arthritis Rheum. 2009 Apr;60(4):955-65. doi: 10.1002/art.24389.
PubMed 19333939Ciccia F, Ferrante A, Triolo G. Intestinal dysbiosis and innate immune responses in axial spondyloarthritis. Curr Opin Rheumatol. 2016 Jul;28(4):352-8. doi: 10.1097/BOR.0000000000000296.
PubMed 27214393Ciccia F, Guggino G, Rizzo A, Alessandro R, Luchetti MM, Milling S, Saieva L, Cypers H, Stampone T, Di Benedetto P, Gabrielli A, Fasano A, Elewaut D, Triolo G. Dysbiosis and zonulin upregulation alter gut epithelial and vascular barriers in patients with ankylosing spondylitis. Ann Rheum Dis. 2017 Jun;76(6):1123-1132. doi: 10.1136/annrheumdis-2016-210000. Epub 2017 Jan 9.
PubMed 28069576Costello ME, Ciccia F, Willner D, Warrington N, Robinson PC, Gardiner B, Marshall M, Kenna TJ, Triolo G, Brown MA. Brief Report: Intestinal Dysbiosis in Ankylosing Spondylitis. Arthritis Rheumatol. 2015 Mar;67(3):686-691. doi: 10.1002/art.38967.
PubMed 25417597De Vos M, Mielants H, Cuvelier C, Elewaut A, Veys E. Long-term evolution of gut inflammation in patients with spondyloarthropathy. Gastroenterology. 1996 Jun;110(6):1696-703. doi: 10.1053/gast.1996.v110.pm8964393.
PubMed 8964393Huttenhower C, Kostic AD, Xavier RJ. Inflammatory bowel disease as a model for translating the microbiome. Immunity. 2014 Jun 19;40(6):843-54. doi: 10.1016/j.immuni.2014.05.013.
PubMed 24950204Jalanka J, Mattila E, Jouhten H, Hartman J, de Vos WM, Arkkila P, Satokari R. Long-term effects on luminal and mucosal microbiota and commonly acquired taxa in faecal microbiota transplantation for recurrent Clostridium difficile infection. BMC Med. 2016 Oct 11;14(1):155. doi: 10.1186/s12916-016-0698-z.
PubMed 27724956Knodler LA, Crowley SM, Sham HP, Yang H, Wrande M, Ma C, Ernst RK, Steele-Mortimer O, Celli J, Vallance BA. Noncanonical inflammasome activation of caspase-4/caspase-11 mediates epithelial defenses against enteric bacterial pathogens. Cell Host Microbe. 2014 Aug 13;16(2):249-256. doi: 10.1016/j.chom.2014.07.002.
PubMed 25121752Leirisalo-Repo M, Turunen U, Stenman S, Helenius P, Seppala K. High frequency of silent inflammatory bowel disease in spondylarthropathy. Arthritis Rheum. 1994 Jan;37(1):23-31. doi: 10.1002/art.1780370105.
PubMed 8129761Mattila E, Uusitalo-Seppala R, Wuorela M, Lehtola L, Nurmi H, Ristikankare M, Moilanen V, Salminen K, Seppala M, Mattila PS, Anttila VJ, Arkkila P. Fecal transplantation, through colonoscopy, is effective therapy for recurrent Clostridium difficile infection. Gastroenterology. 2012 Mar;142(3):490-6. doi: 10.1053/j.gastro.2011.11.037. Epub 2011 Dec 7.
PubMed 22155369Nurmi K, Virkanen J, Rajamaki K, Niemi K, Kovanen PT, Eklund KK. Ethanol inhibits activation of NLRP3 and AIM2 inflammasomes in human macrophages--a novel anti-inflammatory action of alcohol. PLoS One. 2013 Nov 11;8(11):e78537. doi: 10.1371/journal.pone.0078537. eCollection 2013.
PubMed 24244322Nurmi K, Kareinen I, Virkanen J, Rajamaki K, Kouri VP, Vaali K, Levonen AL, Fyhrquist N, Matikainen S, Kovanen PT, Eklund KK. Hemin and Cobalt Protoporphyrin Inhibit NLRP3 Inflammasome Activation by Enhancing Autophagy: A Novel Mechanism of Inflammasome Regulation. J Innate Immun. 2017;9(1):65-82. doi: 10.1159/000448894. Epub 2016 Sep 22.
PubMed 27655219Rajamaki K, Lappalainen J, Oorni K, Valimaki E, Matikainen S, Kovanen PT, Eklund KK. Cholesterol crystals activate the NLRP3 inflammasome in human macrophages: a novel link between cholesterol metabolism and inflammation. PLoS One. 2010 Jul 23;5(7):e11765. doi: 10.1371/journal.pone.0011765.
PubMed 20668705
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Gut Microbiota in the Pathogenesis of Ankylosing Spondylitis (AS), and the Effect of Fecal Microbiota Transplantation on Gut Microbiota, Gut Wall Inflammation and Clinical Activity of AS
- ClinicalTrials.gov ID
- NCT03726645
- Acronym / sponsor ID
- ASGUT / HospitalDHU/Rheumatology
- Conditions
- Ankylosing Spondylitis
- Keywords
- ankylosing spondylitis, fecal microbiota transplantation, intestinal mucosal immunity, dysbiosis, microbiome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital District of Helsinki and UusimaaUniversity, hospital or other
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 31 Oct 2018 (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.
Ankylosing spondylitis (AS) patients often have subclinical gut wall inflammation. Gut dysbiosis has been associated with both AS and Crohn disease, both of which have several features in common. Gut dysbiosis is associated with specific microbial profile in AS patients. Fecal microbiota transplantation (FMT) has been proved to be safe and effective treatment for recurrent Clostridium difficile infection, and the change in gut microbiota is shown to be long lasting. It has led to interest to study its effect on different inflammatory conditions associated with gut dysbiosis.
We hypothesize that dysbiosis in AS leads to inflammasome overactivation on gut mucosa. We aim to study the role of gut inflammation, gut microbiota and inflammasome activation in pathogenesis of AS, and the effect of FMT on these factors, as well as clinical activity, in AS patients.
Detailed description
This is a double-blind placebo- controlled randomized pilot study with 20 patients with active AS from 2 Finnish outpatient clinics. An ileocolonoscopy will be performed to all patients. 10 patients will receive FMT with feces of one of two healthy donors, and 10 patients with their own feces during ileocolonoscopy. Ileal and colonic biopsies will be taken to assess gut wall inflammation and mucosal microbiota composition. Ileocolonoscopy will be controlled in 6 months in patients with macroscopic inflammatory lesions in the first colonoscopy. From mucosal biopsies we will assess intestinal mucosal structure, inflammasome activity, cytokine expression, and the mucin layer thickness and the amount of bacterial LPS (lipopolysaccharide), which are associated with mucosal integrity. Blood levels of zonulin and LPS as indicators of mucosal permeability and bacterial penetrance will be assessed. Fecal samples will be collected repeatedly to measure fecal calprotectin, and to assess the bacterial profile changes. From mucosal biopsies and fecal samples microbial DNA will be segregated and bacterial species sorted by rRNA- based sequence technique. Clinical activity of AS will be assessed in follow-up visits as well as repeated BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), BASFI (Bath Ankylosing Spondylitis Functional Index) and MASES (Maastricht Ankylosing Spondylitis Enthesitis Score) evaluations, and measurement of CRP (C-reactive protein) and ESR (erythrocyte sedimentation rate). Follow-up time is 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Other: Fecal microbiota transplantationAllogeneic fecal microbiota transplantation (from donor) |
| Control group | Placebo comparator | Other: Fecal microbiota transplantationAutologous fecal microbiota transplantation (own stool) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of AS by either the 1984 New York criteria or the ASAS (Assessment of SpondyloArthritis International Society) criteria for axial spondyloarthritis.
- Active disease measured by BASDAI > 4.
- Availability of consecutive fecal samples over 1 year period.
- Compliance to attend ileocolonoscopy and FMT procedure.
Key exclusion criteria (6 listed)
- Diagnosis of inflammatory bowel disease.
- Antibiotic therapy within the last 3 months.
- Use of any probiotics within the last 3 months.
- Pregnancy.
- Unability to provide a written consent.
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 |
|---|---|---|
| Fecal microbiota transplantationFecal microbiota transplantation | Other | Control group, Study group |
Primary outcome
The effect of FMT (fecal microbiota transplantation) on the clinical activity of ankylosing spondylitis (AS) as assessed by change in BASDAI (Bath Ankylosing Spondylitis Disease Activity Index).
Time frame: 5 measurements within 12 months
BASDAI scale 0-10 (the higher the score the more severe the symptoms). Decrease in BASDAI indicates positive outcome.
17 secondary outcomes
The effect of FMT on the clinical activity of AS as assessed by change in BASFI (Bath Ankylosing Spondylitis Functional Index).
Time frame: 5 measurements within 12 months.
The effect of FMT on the clinical activity of AS as assessed by change in MASES (Maastricht Ankylosing Spondylitis Enthesitis Score).
Time frame: 5 measurements within 12 months.
The effect of FMT on C-reactive protein (CRP) concentration.
Time frame: 7 measurements within 12 months.
The effect of FMT on erythrocyte sedimentation rate (ESR) level.
Time frame: 7 measurements within 12 months.
The effect of FMT on gut wall inflammation as assessed by change in fecal calprotectin (F-calpro) level.
Time frame: 7 measurements within 12 months.
The effect of FMT on gut microbiota composition in AS patients.
Time frame: 7 stool microbial analysis within 12 months.
Association between specific intestinal pathogens and disease activity as assessed by BASDAI score.
Time frame: 7 stool microbial samples and 5 BASDAI measurements within 12 months.
Association between specific intestinal pathogens and disease activity as assessed by CRP concentration.
Time frame: 7 stool microbial samples and 7 CRP measurements within 12 months.
Association between gut wall cytokine expression and disease activity as assessed by BASDAI score.
Time frame: Intestinal biopsies at baseline.
Association between gut wall inflammasome activity and disease activity as assessed by BASDAI score.
Time frame: Intestinal biopsies at baseline.
Association between gut wall cytokine expression and disease activity as assessed by CRP concentration.
Time frame: Intestinal biopsies at baseline.
Association between gut wall inflammasome activity and disease activity as assessed by CRP concentration.
Time frame: Intestinal biopsies at baseline.
Association between F-Calpro level and disease activity as assessed by BASDAI score.
Time frame: 7 F-Calpro- measurements and 5 BASDAI measurements within 12 months.
Association between F-Calpro level and disease activity as assessed by CRP concentration.
Time frame: 7 F-Calpro and CRP measurements within 12 months.
The effect of FMT on gut wall permeability as assessed by blood zonulin concentration.
Time frame: 5 measurements within 12 months.
The effect of FMT on gut wall bacterial penetrance as assessed by lipopolysaccharide (LPS) concentration.
Time frame: 5 measurements within 12 months.
The effect of FMT on gastrointestinal symptoms as assessed by GSRS (The Gastrointestinal Symptom Rating Scale).
Time frame: 5 GSRS evaluations within 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Background: PubMed 22827693Anderson JL, Edney RJ, Whelan K. Systematic review: faecal microbiota transplantation in the management of inflammatory bowel disease. Aliment Pharmacol Ther. 2012 Sep;36(6):503-16. doi: 10.1111/j.1365-2036.2012.05220.x. Epub 2012 Jul 25.
- Background: PubMed 28606969Breban M, Tap J, Leboime A, Said-Nahal R, Langella P, Chiocchia G, Furet JP, Sokol H. Faecal microbiota study reveals specific dysbiosis in spondyloarthritis. Ann Rheum Dis. 2017 Sep;76(9):1614-1622. doi: 10.1136/annrheumdis-2016-211064. Epub 2017 Jun 12.
- Background: PubMed 19333939Ciccia F, Bombardieri M, Principato A, Giardina A, Tripodo C, Porcasi R, Peralta S, Franco V, Giardina E, Craxi A, Pitzalis C, Triolo G. Overexpression of interleukin-23, but not interleukin-17, as an immunologic signature of subclinical intestinal inflammation in ankylosing spondylitis. Arthritis Rheum. 2009 Apr;60(4):955-65. doi: 10.1002/art.24389.
- Background: PubMed 27214393Ciccia F, Ferrante A, Triolo G. Intestinal dysbiosis and innate immune responses in axial spondyloarthritis. Curr Opin Rheumatol. 2016 Jul;28(4):352-8. doi: 10.1097/BOR.0000000000000296.
- Background: PubMed 28069576Ciccia F, Guggino G, Rizzo A, Alessandro R, Luchetti MM, Milling S, Saieva L, Cypers H, Stampone T, Di Benedetto P, Gabrielli A, Fasano A, Elewaut D, Triolo G. Dysbiosis and zonulin upregulation alter gut epithelial and vascular barriers in patients with ankylosing spondylitis. Ann Rheum Dis. 2017 Jun;76(6):1123-1132. doi: 10.1136/annrheumdis-2016-210000. Epub 2017 Jan 9.
- Background: PubMed 25417597Costello ME, Ciccia F, Willner D, Warrington N, Robinson PC, Gardiner B, Marshall M, Kenna TJ, Triolo G, Brown MA. Brief Report: Intestinal Dysbiosis in Ankylosing Spondylitis. Arthritis Rheumatol. 2015 Mar;67(3):686-691. doi: 10.1002/art.38967.
- Background: PubMed 8964393De Vos M, Mielants H, Cuvelier C, Elewaut A, Veys E. Long-term evolution of gut inflammation in patients with spondyloarthropathy. Gastroenterology. 1996 Jun;110(6):1696-703. doi: 10.1053/gast.1996.v110.pm8964393.
- Background: PubMed 24950204Huttenhower C, Kostic AD, Xavier RJ. Inflammatory bowel disease as a model for translating the microbiome. Immunity. 2014 Jun 19;40(6):843-54. doi: 10.1016/j.immuni.2014.05.013.
- Background: PubMed 27724956Jalanka J, Mattila E, Jouhten H, Hartman J, de Vos WM, Arkkila P, Satokari R. Long-term effects on luminal and mucosal microbiota and commonly acquired taxa in faecal microbiota transplantation for recurrent Clostridium difficile infection. BMC Med. 2016 Oct 11;14(1):155. doi: 10.1186/s12916-016-0698-z.
- Background: PubMed 25121752Knodler LA, Crowley SM, Sham HP, Yang H, Wrande M, Ma C, Ernst RK, Steele-Mortimer O, Celli J, Vallance BA. Noncanonical inflammasome activation of caspase-4/caspase-11 mediates epithelial defenses against enteric bacterial pathogens. Cell Host Microbe. 2014 Aug 13;16(2):249-256. doi: 10.1016/j.chom.2014.07.002.
- Background: PubMed 8129761Leirisalo-Repo M, Turunen U, Stenman S, Helenius P, Seppala K. High frequency of silent inflammatory bowel disease in spondylarthropathy. Arthritis Rheum. 1994 Jan;37(1):23-31. doi: 10.1002/art.1780370105.
- Background: PubMed 22155369Mattila E, Uusitalo-Seppala R, Wuorela M, Lehtola L, Nurmi H, Ristikankare M, Moilanen V, Salminen K, Seppala M, Mattila PS, Anttila VJ, Arkkila P. Fecal transplantation, through colonoscopy, is effective therapy for recurrent Clostridium difficile infection. Gastroenterology. 2012 Mar;142(3):490-6. doi: 10.1053/j.gastro.2011.11.037. Epub 2011 Dec 7.
- Individual participant dataSharing planned: Undecided
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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.
Kari K Eklund, PhD, MD study director
Hospital District of Helsinki and Uusimaa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fecal microbiota transplantation in people with Ankylosing Spondylitis, run by Hospital District of Helsinki and Uusimaa at 1 site in Finland.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The effect of FMT (fecal microbiota transplantation) on the clinical activity of ankylosing spondylitis (AS) as assessed by change in BASDAI (Bath Ankylosing Spondylitis Disease Activity Index). (time frame: 5 measurements within 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03726645, which also lists 21 linked publications.
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 31 May 2019.