Axial SpondyloarthritisPhase 2/3FMT-SpANCT05654753
The Efficacy of Fecal Microbiota Transplatation on Axial Spondyloarthritis Patients Resistant to Conventional Treatment
A Phase 2/3 study testing active FMT in people with Axial Spondyloarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Current pharmacological management of inflammatory rheumatism and in particular axial SpA remains imperfect. Only 50% of patients respond to the most effective biotherapies, and many of them are only partially relieved. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- active FMT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2024to Sep 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Adult patient (age 18 to 75 years old) with SpA, meeting the ASAS classification criteria for axial SpA, with presence of radiographic sacro-illitis (ankylosing spondylitis) or not.
- Patient suffering of active SpA, with or without treatment, having a BASDAI score ≥ 4 (0-10) at baseline and a score of back pain ≥ 4 (0-10) despite optimal drug management for at least 6 months including at least 2 different NSAIDs at the maximum tolerated dose for at least 2 months (or less in case of intolerance or contra-indication) and at least a first line of biotherapy (anti-TNFα or anti-IL-17) for at least 4 months (or less in case of intolerance or contra-indication).
- Subjects are allowed to continue NSAID, sulfasalazin (≤ 3 g/day) and/or methotrextae ( ≤ 25 mg/week) and/or hydroxychloroquine (≤ 400 mg/day) and/or oral corticosteroid (≤ 10 mg/day of prednisone), as long as these treatments have remained at stable dose for 4 weeks prior to baseline.
- Subjects are allowed to continue anti-TNFα, anti-IL-17 or JAKinhibitor therapies, as long as these treatments have remained at stable dose for 3 months prior to baseline.
- Women of childbearing potential with efficient contraceptive protection at the inclusion and during at least the interventional phase (D168).
- Patient with health insurance (AME except).
- Patient is willing to provide written informed consent prior to enrolment and agrees to follow the protocol.
Who cannot join
- Patient under legal protection (guardianship or curatorship)
- Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development
- Pregnant or breastfeeding woman
- Patient with IBD in active state, according to the judgment of the Investigator
- Corticosteroid injection within 4 weeks before inclusion
- Active infection according to the judgment of the Investigator
Show all 23Show fewer
- Any antibiotic (including Sulfasalazin) or antifungal treatment within 4 weeks before inclusion
- Probiotics intake within 4 weeks before inclusion
- Known infection with Clostridoides difficile or Escherichia coli within 10 days before inclusion
- Patients with unstable severe condition other than axial SpA on that could jeopardize treatment procedure or evaluation according to the investigator's assessment
- Previous FMT treatment
- Contra-indication to colon preparation (Moviprep® or Moviprep orange®) according to SmPC
- Current or past evidence of bowel obstruction
- Confirmed or suspected intestinal ischemia
- Confirmed or suspected toxic megacolon or gastrointestinal perforation
- Extended colectomy (> two-thirds of colon)
- Any gastro-intestinal bleeding in the past 3 months before inclusion
- Any history of gastro-intestinal surgery in the past 3 months before inclusion
- Severe organ dysfunction
- Any contra-indication to swallow capsules
- Known allergy or intolerance to IMP and / or excipients according to Investigator's Brochure
- Lack of access to a refrigerator to store the medication (MaaT033® or MaaT030®)
- Concomitant participation in another interventional clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Rheumatology Department, Ambroise Paré hospital - APHP
Boulogne-Billancourt, 92100
About this study
Official title: RANDOMIZED DOUBLE BLIND CONTROLLED STUDY ASSESSING THE EFFICACY OF FECAL MICROBIOTA TRANSPLANTATION IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS RESISTANT TO CONVENTIONAL TREATMENT
Current pharmacological management of inflammatory rheumatism and in particular axial SpA remains imperfect. Only 50% of patients respond to the most effective biotherapies, and many of them are only partially relieved. In addition, these are extremely expensive treatments that expose them to the risk of potentially serious side effects. Compelling evidence indicates that gut dybiosis could be a critical trigger of inflammation in axial SpA and thus correcting dysbiosis represents an attractive way of reversing the pathogenic process.The efficacy of FMT in patients with axial SpA has never been studied. This randomized double-blind study will be the first to assess feasability of FMT in axial SpA, the capacity of this procedure to restore healthy microbiome, its tolerance and its potential efficacy on disease activity. If sucessfull, this trial would set the path to larger-scale clinical trials of FMT to treat axial SpA.
Two-co primary objectives in a hierarchical design:
- to evaluate the capacity of FMT to correct dysbiosis in active axial SpA despite well-conducted phamacological treatment by replacing pre-existing dysbiotic microbiota with healthier microbiota.
- to explore the efficacy of FMT versus placebo on clinical evolution of SpA.
Read the detailed description
Axial spondyloarthritis (SpA) is a chronic inflammatory disease primarily affecting the sacroiliac and spinal joints that usually begins in young adults and is a major cause of chronic pain and disability that profoundly alter the quality of life of patients. Besides non-steroidal anti-inflammatory drugs, the development of anti-tumor necrosis factor-α (TNFα) and anti-interleukin (IL-17) biotherapies and of JAK inhibitors, has improved the management of these patients. However only half of the patients respond to these treatments and many of them are only partially relieved. Remarkably, this disorder frequently combines with overt inflammatory bowel disease (IBD) -i.e. Crohn's disease (CD) or ulcerative colitis (UC)- and even more frequently with subclinical gut inflammation, leading to suspect a role of the gut microbiota as a possible trigger. Consistently, recent studies evidenced an alteration of gut microbiota composition -or dysbiosis- in the course of SpA that appeared all the more pronounced that disease was more active. It was notably shown a restriction of bacterial diversity and an expansion of species considered as potentially pro-inflammatory, including Ruminococcus gnavus. Given its potential involvement in the pathogenesis of SpA, gut microbiota could be considéred as a promising therapeutic target. Fecal microbiota transplantation (FMT) is a technic consisting in thorough replacement of dysbiotic microbiota by healthy dondor's microbiota that has recently been developped to correct dysbiosis. It has been validated for the treatment of intractable colitis due to Clostridium difficile and its efficacy has been reported in CD or UC. The current trial, aims to evaluate efficacy of FMT in drug-resistant axial SpA.
- Conditions
- Axial Spondyloarthritis
- Being tested
- active FMT, Placebo
- Keywords
- Axial Spondyloarthritis, dysbiotic microbiota, Fecal microbiota transplantation, eubiotic microbiota
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active FMTDrug
MaaT033®, a lyophilized full-ecosystem intestinal microbiota delayed release oral capsule containing native, donor-derived (pooled from 4-6 donors) microbiome product manufactured by MaaT Pharma® will be delivered orally. Patients will receive 20 Maat033 capsules, each containing approximatively 0.42 g of microbiome product at once at day 0, then 3 capsules/day from day 1 through day 20.
PlaceboDrug
Patients will receive 20 capsules placebo, each containing placebo at once at day 0, then 3 capsules/day from day 1 through day 20.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | active FMT Receives: Drug: active FMT |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in gut Metagenome Species Pangenome (MSP) richness in the "intervention" arm.
Fecal microbiota composition will be assessed by thorough microbial DNA sequencing (shotgun) at baseline (anytime between D-4 and D-1) and then at D28, D42, D84 and D168. The success will be evaluated by an increase in gut Metagenome Species Pangenome (MSP) richness over the period of study.
Measured: at baseline and D 42
The proportion of patients satisfying ASAS 20 improvement criteria by randomization group
ASAS20 is defined by an improvement of ≥ 20% and of ≥ 10 points on a 0-100 numerical scale of 3 of the 4 following domains: global evaluation by the patient (PGA), pain, Bath Ankylosing Spondylitis Functional Index (BASFI) and inflammation (evaluated by the answer to both last questions of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)) as well as an absence of deterioration from baseline by ≥ 20% and by ≥ 10 points in the fourth domain. The comparison of ASAS20 scores at D42 between randomization groups will be an exploratory analysis, considering literature data.
Measured: at D 42
Secondary outcomes (7)
efficacy of FMT
Superior efficacy of FMT over placebo defined by an increase in MSP richness at week 6 in the FMT group, superior to variation in the placebo group
Measured: week 6
Change of dysbiotic fecal microbiota
To correct dysbiotic fecal microbiota at weeks 3, 12 and 24 in FMT-treated group, by comparison with baseline. Fecal microbiota composition will be assessed by thorough microbial DNA sequencing (shotgun), in a way similar to week 6 in FMT and placebo groups and the variation between baseline and different end-points (weeks 3, 12, 24) will be compared between both arms.
Measured: at baseline, at weeks 3, 12 and 24
Clinical improvement
Clinical improvement during the 24 weeks follow-up after FMT or sham-FMT. We will compare between both arms the proportion of patients satisfying ASAS20 improvement criteria at weeks 3, 6, 12 and 24 as compared to baseline (week 0).
[ASAS20 is defined by an improvement of at least 20% and of at least 10 points on a 0-100 scale in ≥ 3 of the following 4 domains: global assessment by the patient (PGA), back pain, Bath Ankylosing Spondylitis Functional Index (BASFI) and inflammation (evaluated by the answer to both last questions of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and absence of deterioration in the potential remaing domain, where deterioration is defined as a change for the worse of ≥ 20% and net worsening of ≥ 10 points (on a scale of 0-100)
Measured: at baseline, weeks 3, 6, 12 and 24
ESR and CRP levels
Improvement of biological inflammation by ESR and CRP levels variation
Measured: at weeks 3, 6, 12 and 24
CHANGE OF ASDAS_CRP and ASDAS_ESR
Improvement of ASDAS_CRP and ASDAS_ESR at weeks 3, 6, 12 and 24
Measured: at weeks 3, 6, 12 and 24
Change in Bath Ankylosing Spondylitis Metrology Index
Improvement of Bath Ankylosing Spondylitis Metrology Index (BASMI) at weeks 3, 6, 12 and 24
Measured: at weeks 3, 6, 12 and 24
non-steroidal anti-inflammatory drugs (NSAID) intake
Decrease of non-steroidal anti-inflammatory drugs (NSAID) intake score.
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start28 Mar 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
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 Assistance Publique - Hôpitaux de ParisThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Arthritis & Clarins Worldwide 2016
- Responsible party
- Sponsor
- Investigators
- Maxime Breban, MD, PhD, Principal investigator, Rheumatology Department - Ambroise Paré hospital - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654753
- Sponsor's protocol ID
- APHP220934
- Other IDs
- 2023-504852-89-00, 2023
- Acronym
- FMT-SpA
- Status last verified
- Apr 2024
- First submitted
- 8 Dec 2022
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RANDOMIZED DOUBLE BLIND CONTROLLED STUDY ASSESSING THE EFFICACY OF FECAL MICROBIOTA TRANSPLANTATION IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS RESISTANT TO CONVENTIONAL TREATMENT
- ClinicalTrials.gov ID
- NCT05654753
- Acronym / sponsor ID
- FMT-SpA / APHP220934
- Conditions
- Axial Spondyloarthritis
- Keywords
- Axial Spondyloarthritis, dysbiotic microbiota, Fecal microbiota transplantation, eubiotic microbiota
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fondation Arthritis & Clarins Worldwide 2016
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 16 Dec 2022 (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.
Current pharmacological management of inflammatory rheumatism and in particular axial SpA remains imperfect. Only 50% of patients respond to the most effective biotherapies, and many of them are only partially relieved. In addition, these are extremely expensive treatments that expose them to the risk of potentially serious side effects. Compelling evidence indicates that gut dybiosis could be a critical trigger of inflammation in axial SpA and thus correcting dysbiosis represents an attractive way of reversing the pathogenic process.The efficacy of FMT in patients with axial SpA has never been studied. This randomized double-blind study will be the first to assess feasability of FMT in axial SpA, the capacity of this procedure to restore healthy microbiome, its tolerance and its potential efficacy on disease activity. If sucessfull, this trial would set the path to larger-scale clinical trials of FMT to treat axial SpA.
Two-co primary objectives in a hierarchical design:
- to evaluate the capacity of FMT to correct dysbiosis in active axial SpA despite well-conducted phamacological treatment by replacing pre-existing dysbiotic microbiota with healthier microbiota.
- to explore the efficacy of FMT versus placebo on clinical evolution of SpA.
Detailed description
Axial spondyloarthritis (SpA) is a chronic inflammatory disease primarily affecting the sacroiliac and spinal joints that usually begins in young adults and is a major cause of chronic pain and disability that profoundly alter the quality of life of patients. Besides non-steroidal anti-inflammatory drugs, the development of anti-tumor necrosis factor-α (TNFα) and anti-interleukin (IL-17) biotherapies and of JAK inhibitors, has improved the management of these patients. However only half of the patients respond to these treatments and many of them are only partially relieved. Remarkably, this disorder frequently combines with overt inflammatory bowel disease (IBD) -i.e. Crohn's disease (CD) or ulcerative colitis (UC)- and even more frequently with subclinical gut inflammation, leading to suspect a role of the gut microbiota as a possible trigger. Consistently, recent studies evidenced an alteration of gut microbiota composition -or dysbiosis- in the course of SpA that appeared all the more pronounced that disease was more active. It was notably shown a restriction of bacterial diversity and an expansion of species considered as potentially pro-inflammatory, including Ruminococcus gnavus. Given its potential involvement in the pathogenesis of SpA, gut microbiota could be considéred as a promising therapeutic target. Fecal microbiota transplantation (FMT) is a technic consisting in thorough replacement of dysbiotic microbiota by healthy dondor's microbiota that has recently been developped to correct dysbiosis. It has been validated for the treatment of intractable colitis due to Clostridium difficile and its efficacy has been reported in CD or UC. The current trial, aims to evaluate efficacy of FMT in drug-resistant axial SpA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: active FMTactive FMT |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patient (age 18 to 75 years old) with SpA, meeting the ASAS classification criteria for axial SpA, with presence of radiographic sacro-illitis (ankylosing spondylitis) or not.
- Patient suffering of active SpA, with or without treatment, having a BASDAI score ≥ 4 (0-10) at baseline and a score of back pain ≥ 4 (0-10) despite optimal drug management for at least 6 months including at least 2 different NSAIDs at the maximum tolerated dose for at least 2 months (or less in case of intolerance or contra-indication) and at least a first line of biotherapy (anti-TNFα or anti-IL-17) for at least 4 months (or less in case of intolerance or contra-indication).
- Subjects are allowed to continue NSAID, sulfasalazin (≤ 3 g/day) and/or methotrextae ( ≤ 25 mg/week) and/or hydroxychloroquine (≤ 400 mg/day) and/or oral corticosteroid (≤ 10 mg/day of prednisone), as long as these treatments have remained at stable dose for 4 weeks prior to baseline.
- Subjects are allowed to continue anti-TNFα, anti-IL-17 or JAKinhibitor therapies, as long as these treatments have remained at stable dose for 3 months prior to baseline.
- Women of childbearing potential with efficient contraceptive protection at the inclusion and during at least the interventional phase (D168).
Key exclusion criteria (23 listed)
- Patient under legal protection (guardianship or curatorship)
- Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development
- Pregnant or breastfeeding woman
- Patient with IBD in active state, according to the judgment of the Investigator
- Corticosteroid injection within 4 weeks before inclusion
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 |
|---|---|---|
| active FMTMaaT033®, a lyophilized full-ecosystem intestinal microbiota delayed release oral capsule containing native, donor-derived (pooled from 4-6 donors) microbiome product manufactured by MaaT Pharma® will be delivered orally. Patients will receive 20 Maat033 capsules, each containing approximatively 0.42 g of microbiome product at once at day 0, then 3 capsules/day from day 1 through day 20. | Drug | Experimental |
| PlaceboPatients will receive 20 capsules placebo, each containing placebo at once at day 0, then 3 capsules/day from day 1 through day 20. | Drug | Placebo |
Primary outcome
Increase in gut Metagenome Species Pangenome (MSP) richness in the "intervention" arm.
Time frame: at baseline and D 42
Fecal microbiota composition will be assessed by thorough microbial DNA sequencing (shotgun) at baseline (anytime between D-4 and D-1) and then at D28, D42, D84 and D168. The success will be evaluated by an increase in gut Metagenome Species Pangenome (MSP) richness over the period of study.
The proportion of patients satisfying ASAS 20 improvement criteria by randomization group
Time frame: at D 42
ASAS20 is defined by an improvement of ≥ 20% and of ≥ 10 points on a 0-100 numerical scale of 3 of the 4 following domains: global evaluation by the patient (PGA), pain, Bath Ankylosing Spondylitis Functional Index (BASFI) and inflammation (evaluated by the answer to both last questions of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)) as well as an absence of deterioration from baseline by ≥ 20% and by ≥ 10 points in the fourth domain. The comparison of ASAS20 scores at D42 between randomization groups will be an exploratory analysis, considering literature data.
7 secondary outcomes
efficacy of FMT
Time frame: week 6
Change of dysbiotic fecal microbiota
Time frame: at baseline, at weeks 3, 12 and 24
Clinical improvement
Time frame: at baseline, weeks 3, 6, 12 and 24
ESR and CRP levels
Time frame: at weeks 3, 6, 12 and 24
CHANGE OF ASDAS_CRP and ASDAS_ESR
Time frame: at weeks 3, 6, 12 and 24
Change in Bath Ankylosing Spondylitis Metrology Index
Time frame: at weeks 3, 6, 12 and 24
non-steroidal anti-inflammatory drugs (NSAID) intake
Time frame: through study completion, an average of 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Axial Spondyloarthritis
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy
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.
Maxime Breban, MD, PhD principal investigator
Rheumatology Department - Ambroise Paré hospital - APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing active FMT in people with Axial Spondyloarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 7 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 9 Apr 2024. 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 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxime Breban, MD, PhD (+33 0149095674, maxime.breban@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in gut Metagenome Species Pangenome (MSP) richness in the "intervention" arm. (time frame: at baseline and D 42). The study lists 2 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 9 Apr 2024.