Bariatric SurgeryPhase 3DRIFTERNCT06192693
Fecal Microbiota Transfer to Improve Diabetes Control Post-bariatric Surgery
A Phase 3 study testing Capsulized fecal microbiota transfer containing the healthy feces + stool dilution solution in people with Bariatric Surgery and Type 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Obesity progresses worldwide with few effective treatments leading to a burst in Bariatric surgery (BS). France is the 3rd country in BS numbers yearly. BS improves diabetes (T2D) and even induces diabetes remission (DR) in 60% of patients. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery, Type 2 Diabetes
- What is being tested?
- Capsulized fecal microbiota transfer containing the healthy feces + stool dilution solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2024to Feb 2029
- Phase
- Phase 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients from 18-65 years old
- T2D patients any severity of initial T2D disease before BS
- Who underwent Bariatric surgery (BS) 1 to 5 years before (Roux-en-Y gastric bypass or sleeve, patients with pre-BS BMI≥35kg/m²)
- Non-Diabetic remission (NDR) patients 1-year post-BS, defined as Hba1c>6.5% and/or fasting glycaemia>6.9mmol/l and/or receiving anti-diabetic drugs for at least 2 months. We will rather select patients with uncontrolled diabetes with Hba1c>7% and willing to receive proton pump inhibitor (PPI)
- Patient compliant to 1rd year follow-up post-BS (who came to at least 2 among the three routine care follow-up visits during the first year (i.e. 3, 6 and 12M)
- Signature of the informed consent
Show all 14Show fewer
- Affiliated to a social security regime (except AME)
- Age ≥ 18 years and < 50 years
- Lean individuals (18<BMI<25kg/m²)
- Euglycemic: fasting glycemia <6mmol/l; Hba1c <5.9%
- Healthy: no current drug prescription (except contraception or pain killers other than AINS)
- Regular bowel movement in the morning defined as 1 stool/day at least
- Signature of the informed consent
- Subject with health insurance (except AME)
Who cannot join
- Type 1 diabetes
- Patients receiving antibiotics (ATB) at the selection time or within the 3 previous months (if agreeing to participate to the study, the patients will be proposed randomization 3 months after stopping ATB)
- Immunosuppressive therapy
- Laxative treatments
- DR since BS (nor relapse patients detailed further in the protocol)
- Patients already recruited in another interventional studies study where a drug is being tested
Show all 17Show fewer
- Pregnant or breastfeeding women
- Patient with contemporary disease such as intestine disease
- Patient under guardianship or curatorship
- Patient deprived of their liberty by a judicial or administrative decision
- Familial history of obesity or diabetes and personal history of overweight/obesity
- Infectious risk
- Gastrointestinal disease
- Exclusion criteria according screening test to National Agency for the Safety of Medicines and Health Products (ANSM) recommendations
- Pregnancy or breastfeeding women
- Subject under guardianship or curatorship
- Subject deprived of their liberty by a judicial or administrative decision
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
Groupe hospitalier Pitié-Salpêtrière
Paris, 75013
Judith Aron-Wisnewsky, Pr, +33 1 42 17 75 41, judith.aron-wisnewsky@aphp.fr
About this study
Obesity progresses worldwide with few effective treatments leading to a burst in Bariatric surgery (BS). France is the 3rd country in BS numbers yearly.
BS improves diabetes (T2D) and even induces diabetes remission (DR) in 60% of patients. Thus, an expert consensus recommended extending BS to T2D with BMI≥30kg/m² with uncontrolled glycaemia, anticipating even more BS. Glycaemic control further deteriorates in the longer term in non DR (NDR) patients and relapse occurs in some DR patients, urging the need to add new therapy to control glycaemia and provide new recommendations in the future.
Read more
Obesity and T2D are characterized by gut microbiota dysbiosis with low to very low microbial gene richness (MGR). About 75% of patients' candidates for BS are in the low MGR category. Whereas BS modifies microbiota composition and increases MGR 1-year post-BS, we demonstrated that only a few patients reach high MGR. Dysbiosis can be improved by several means; fibre enriched diet, prebiotics, probiotics also improve metabolic alterations and insulin resistance in mice. However, human studies observed rather divergent results: some studies display a beneficial effect in improving insulin-resistance but to a small extent while others do not display any significant effects at all. Therefore, other innovative strategies should be tested in humans. For example, Faecal microbiota transfer (FMT) ameliorates insulin sensitivity and MGR in metabolic syndrome patients, but was never tested in T2D nor post-BS. Whether adding such an innovative therapy to further modify gut microbiota post-BS can help improve glucose control should be tested.
FMT showed health benefits in several diseases (clostridium difficile (CD) and Crohn's). Until recently, FMT was performed using invasive tool (endoscopy or colonoscopy) thus with potential secondary effects, or enema yet maybe less effective. Recent technologic developments enabled to generate oral capsulized FMT (filled with fecal material) performing as well as invasive FMT for CD with good tolerance. This strategy has never been tested in obesity or T2D, whereas in metabolic syndrome patients (before T2D occurrence) and less severe dysbiosis, a proof-of-concept study showed that endoscopic FMT may improve insulin sensitivity after 6 weeks. Yet these studies have included a small number of patients, non T2D and did not test oral FMT. We here hypothesize that an intervention improving dysbiosis after 1-year post-BS might help improve/maintain diabetes control in the long-term. We will examine the effects of FMT (from lean healthy donors) vs. placebo transfer in dietary-controlled non-DR patients after 1-year post-BS, on Hba1c reduction evaluated 6 months' post-intervention
- Conditions
- Bariatric Surgery, Type 2 Diabetes
- Being tested
- Capsulized fecal microbiota transfer containing the healthy feces + stool dilution solution, Capsulized placebo transfer containing dilution solution
- Keywords
- fecal microbiota transfer (FMT)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsulized fecal microbiota transfer containing the healthy feces + stool dilution solutionDrug
1 FMT=30 capsulized FMT given during 2 days in several intakes per day (3 intakes per day).
FMT will be performed at baseline after randomization. Further treatment(s) will be given again at 6 and 12 weeks if we do not observe a change of Hba1c of at least -0.15% in patients who have Hba1c at inclusion <7%; of at least -0.4% in patients who have Hba1c at inclusion ≤8% and of at least -0.7% in patients who have Hba1c at inclusion >8%.
Capsulized placebo transfer containing dilution solutionDrug
1 Placebo of FMT=30 capsulized given during 2 days in several intakes per day (3 intakes per day).
Placebo of FMT will be performed at baseline after randomization. Further treatment(s) will be given again at 6 and 12 weeks if we do not observe a change of Hba1c of at least -0.15% in patients who have Hba1c at inclusion <7%; of at least -0.4% in patients who have Hba1c at inclusion ≤8% and of at least -0.7% in patients who have Hba1c at inclusion >8%.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | FMT (from healthy lean euglycemic non-obese donors) Receives: Drug: Capsulized fecal microbiota transfer containing the healthy feces + stool dilution solution |
| 2 | Placebo comparator | Placebo of FMT Receives: Drug: Capsulized placebo transfer containing dilution solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hba1c change from baseline to 6 months post randomization
Measured: At baseline and at 6 months after randomization
Secondary outcomes (11)
Evolution of Hba1c from baseline to 2 years post-randomization
Measured: At baseline and at 6 weeks, 12 weeks, 18 weeks, 24 weeks, 1 year and 2 years post randomization
Evolution of C-peptide from baseline to 2 years post-randomization
Measured: At baseline and at 6 weeks, 12 weeks, 18 weeks, 24 weeks, 1 year and 2 years post randomization
Evolution of insulin secretion from baseline to 24 weeks using the HOMA-B calculator
Equal to 20 x fasting insulin (μIU/ml)/ fasting glucose (mmol/ml) - 3.5
Measured: At baseline and at 24 weeks post-randomization
Evolution of insulin resistance from baseline to 24 weeks
we will use the HOMA-IR (= fasting insulin (μIU/ml) × fasting glucose (mmol/ml)/ 22.5) and Disse index (=Disse 12*((2.5*(HDL-total cholesterol)-NEFA)-insulin)) which are two complementary markers to evaluate insulin resistance using different parameters
Measured: At baseline and at 24 weeks post-randomization
Glycaemia profile (using glycemic holter) changes from baseline to 6 weeks and 24 weeks
Glycemic holter will be placed on the patient for 3 days at baseline, 6 weeks and 6 months and will collect glycemic curve excursions that will further be compared at the different visits (baseline, 6 and 24 weeks). We will analyse the % and duration of hyperglycemia and hypoglycaemia and the % of time and duration at glycemic target at the different visits (baseline, 6 and 24 weeks)
Measured: At baseline and at 6 weeks and 24 weeks post-randomization
Number of anti-diabetic (antiT2D) drugs
The number of concomitant anti-diabetic drugs will be analysed
Measured: At baseline and at 1 and 2 years post-randomization
Type of antiT2D drugs
The type of anti-diabetic drugs will be analysed
Measured: At baseline and at 1 and 2 years post-randomization
Number of patients reaching Diabetic Remission (DR)
Measured: At baseline and at 24 weeks, 1 and 2 years post-randomization
Proportion of patient needing a "safety" glucose lowering treatment to control Hba1c despite FMTs (or placebo)
Measured: From baseline to 2 years post-randomization
Evaluate FMT safety
Evaluate safety and AE by a systematic screening regarding fever, bloating, diarrhoea, regurgitation at each visit
Measured: From baseline to 2 years post-randomization
Evaluate quality of life
Evaluate changes in quality of life after capsulized FMT (baseline vs. after FMT and between treatment groups using SF36 questionnaire)
Measured: At baseline and at 6 weeks, 12 weeks, 18 weeks, 24 weeks, 1 year and 2 years post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start21 Jan 2024
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192693
- Sponsor's protocol ID
- APHP180591
- Other IDs
- 2019-003841-13, 2019
- Acronym
- DRIFTER
- Status last verified
- Feb 2025
- First submitted
- 21 Dec 2023
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transfer to Improve Diabetes Control Post-bariatric Surgery
- ClinicalTrials.gov ID
- NCT06192693
- Acronym / sponsor ID
- DRIFTER / APHP180591
- Conditions
- Bariatric Surgery, Type 2 Diabetes
- Keywords
- fecal microbiota transfer (FMT)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 21 Jan 2024 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 5 Jan 2024 (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.
Obesity progresses worldwide with few effective treatments leading to a burst in Bariatric surgery (BS). France is the 3rd country in BS numbers yearly.
BS improves diabetes (T2D) and even induces diabetes remission (DR) in 60% of patients. Thus, an expert consensus recommended extending BS to T2D with BMI≥30kg/m² with uncontrolled glycaemia, anticipating even more BS. Glycaemic control further deteriorates in the longer term in non DR (NDR) patients and relapse occurs in some DR patients, urging the need to add new therapy to control glycaemia and provide new recommendations in the future.
Obesity and T2D are characterized by gut microbiota dysbiosis with low to very low microbial gene richness (MGR). About 75% of patients' candidates for BS are in the low MGR category. Whereas BS modifies microbiota composition and increases MGR 1-year post-BS, we demonstrated that only a few patients reach high MGR. Dysbiosis can be improved by several means; fibre enriched diet, prebiotics, probiotics also improve metabolic alterations and insulin resistance in mice. However, human studies observed rather divergent results: some studies display a beneficial effect in improving insulin-resistance but to a small extent while others do not display any significant effects at all. Therefore, other innovative strategies should be tested in humans. For example, Faecal microbiota transfer (FMT) ameliorates insulin sensitivity and MGR in metabolic syndrome patients, but was never tested in T2D nor post-BS. Whether adding such an innovative therapy to further modify gut microbiota post-BS can help improve glucose control should be tested.
FMT showed health benefits in several diseases (clostridium difficile (CD) and Crohn's). Until recently, FMT was performed using invasive tool (endoscopy or colonoscopy) thus with potential secondary effects, or enema yet maybe less effective. Recent technologic developments enabled to generate oral capsulized FMT (filled with fecal material) performing as well as invasive FMT for CD with good tolerance. This strategy has never been tested in obesity or T2D, whereas in metabolic syndrome patients (before T2D occurrence) and less severe dysbiosis, a proof-of-concept study showed that endoscopic FMT may improve insulin sensitivity after 6 weeks. Yet these studies have included a small number of patients, non T2D and did not test oral FMT. We here hypothesize that an intervention improving dysbiosis after 1-year post-BS might help improve/maintain diabetes control in the long-term. We will examine the effects of FMT (from lean healthy donors) vs. placebo transfer in dietary-controlled non-DR patients after 1-year post-BS, on Hba1c reduction evaluated 6 months' post-intervention
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 |
|---|---|---|
| 1 | Experimental | Drug: Capsulized fecal microbiota transfer containing the healthy feces + stool dilution solutionFMT (from healthy lean euglycemic non-obese donors) |
| 2 | Placebo comparator | Drug: Capsulized placebo transfer containing dilution solutionPlacebo of FMT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adult patients from 18-65 years old
- T2D patients any severity of initial T2D disease before BS
- Who underwent Bariatric surgery (BS) 1 to 5 years before (Roux-en-Y gastric bypass or sleeve, patients with pre-BS BMI≥35kg/m²)
- Non-Diabetic remission (NDR) patients 1-year post-BS, defined as Hba1c>6.5% and/or fasting glycaemia>6.9mmol/l and/or receiving anti-diabetic drugs for at least 2 months. We will rather select patients with uncontrolled diabetes with Hba1c>7% and willing to receive proton pump inhibitor (PPI)
- Patient compliant to 1rd year follow-up post-BS (who came to at least 2 among the three routine care follow-up visits during the first year (i.e. 3, 6 and 12M)
Key exclusion criteria (17 listed)
- Type 1 diabetes
- Patients receiving antibiotics (ATB) at the selection time or within the 3 previous months (if agreeing to participate to the study, the patients will be proposed randomization 3 months after stopping ATB)
- Immunosuppressive therapy
- Laxative treatments
- DR since BS (nor relapse patients detailed further in the protocol)
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 |
|---|---|---|
| Capsulized fecal microbiota transfer containing the healthy feces + stool dilution solution1 FMT=30 capsulized FMT given during 2 days in several intakes per day (3 intakes per day). FMT will be performed at baseline after randomization. Further treatment(s) will be given again at 6 and 12 weeks if we do not observe a change of Hba1c of at least -0.15% in patients who have Hba1c at inclusion <7%; of at least -0.4% in patients who have Hba1c at inclusion ≤8% and of at least -0.7% in patients who have Hba1c at inclusion >8%. | Drug | 1 |
| Capsulized placebo transfer containing dilution solution1 Placebo of FMT=30 capsulized given during 2 days in several intakes per day (3 intakes per day). Placebo of FMT will be performed at baseline after randomization. Further treatment(s) will be given again at 6 and 12 weeks if we do not observe a change of Hba1c of at least -0.15% in patients who have Hba1c at inclusion <7%; of at least -0.4% in patients who have Hba1c at inclusion ≤8% and of at least -0.7% in patients who have Hba1c at inclusion >8%. | Drug | 2 |
Primary outcome
Hba1c change from baseline to 6 months post randomization
Time frame: At baseline and at 6 months after randomization
11 secondary outcomes
Evolution of Hba1c from baseline to 2 years post-randomization
Time frame: At baseline and at 6 weeks, 12 weeks, 18 weeks, 24 weeks, 1 year and 2 years post randomization
Evolution of C-peptide from baseline to 2 years post-randomization
Time frame: At baseline and at 6 weeks, 12 weeks, 18 weeks, 24 weeks, 1 year and 2 years post randomization
Evolution of insulin secretion from baseline to 24 weeks using the HOMA-B calculator
Time frame: At baseline and at 24 weeks post-randomization
Evolution of insulin resistance from baseline to 24 weeks
Time frame: At baseline and at 24 weeks post-randomization
Glycaemia profile (using glycemic holter) changes from baseline to 6 weeks and 24 weeks
Time frame: At baseline and at 6 weeks and 24 weeks post-randomization
Number of anti-diabetic (antiT2D) drugs
Time frame: At baseline and at 1 and 2 years post-randomization
Type of antiT2D drugs
Time frame: At baseline and at 1 and 2 years post-randomization
Number of patients reaching Diabetic Remission (DR)
Time frame: At baseline and at 24 weeks, 1 and 2 years post-randomization
Proportion of patient needing a "safety" glucose lowering treatment to control Hba1c despite FMTs (or placebo)
Time frame: From baseline to 2 years post-randomization
Evaluate FMT safety
Time frame: From baseline to 2 years post-randomization
Evaluate quality of life
Time frame: At baseline and at 6 weeks, 12 weeks, 18 weeks, 24 weeks, 1 year and 2 years post randomization
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 17 Feb 2025.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capsulized fecal microbiota transfer containing the healthy feces + stool dilution solution in people with Bariatric Surgery and Type 2 Diabetes, 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 14 inclusion and 17 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 17 Feb 2025. 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 phase mean?
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 Judith Aron-Wisnewsky, Pr (+33 1 42 17 75 41, judith.aron-wisnewsky@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hba1c change from baseline to 6 months post randomization (time frame: At baseline and at 6 months after randomization). 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 17 Feb 2025.