Correcting GUT MicrobioTa by Combined Supplementation of FibERs and BIotiN to Improve Microbiome and Optimize Bariatric Surgery Outcomes
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 5 people enrolled
- Started
- 24 Jul 2023
- Ended
- 24 Dec 2024
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Standard of care
- Biotin supplement
- Fiber supplement
- Record updated
- 15 January 2025
- Why it stopped
- end of ERC funding period
Who can take part
- Age
- 18 years to 60 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Age ≥ 18 years and < 60 years
- BMI ≥ 40 kg/m² or BMI > 35 kg/m² with at least one comorbidity belonging to metabolic syndrome (hyperglycemia (fasting glycemia > 1g/l, Non diabetic with HbA1C<7% without antidiabetic treatment), dyslipidemia (HDL-cholesterol <0.5 g/l or receiving treatment against dyslipidemia), or increased blood pressure (SBP >13, DBP>9 or treated by antihypertensive drug)), or sleep apnoea, weight stable (less than 3 kg variation in the 2 months before
- Usual Fiber intake < 20g/day in food consumption evaluated by 24h recall
- Signature of the informed consent
- Effective contraception in women of childbearing age
- Subject with health insurance (except AME)
Who cannot take part
- Patients receiving antibiotics (ATB) at the selection time or within the 2 previous months; (if agreeing to participate to the study, the patients will be proposed randomization 3 months after stopping ATB)
- Previous history of gastrointestinal neoplasia or polyps
- Factors that may affect the composition of the intestinal microbiota: Special Diet (exclusion diet, vegetarian diet), taking immunosuppressants (eg calcineurin inhibitors, corticosteroids, biological agents, etc.), taking transit modulators (osmotic or prebiotics such as lactulose)
- Type 1 or type 2 diabetes
- HIV, HBV, HCV
- Gastrointestinal disease: Acute or chronic diarrhea (i.e. more than 3 liquid or fluid stools/day)
- Pregnancy or breastfeeding women
- Subject under guardianship or curatorship
- Subject deprived of their liberty by a judicial or administrative decision
- Patient participating to another interventional clinical research (Jardé 1)
- Subject physically unable to give his or her written consent
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Bariatric surgery improves health outcomes with a maximal weight loss on average occurring 1 year after surgery but with dramatic between-subjects variability in weight loss (ranging from 20 to 160% excess weight loss) for reasons that remain to be elucidated.
Read full original descriptionShow less
The investigators hypothesize that targeting the 3 months pre-surgery period by a calibrated dietary intervention, with fiber enrichment and biotin, will improve gut microbiota richness and subsequently improve subjects' metabolic health that may optimize post bariatric surgery outcomes.
The study is designed as a pilot, comparative, randomized, open-label trial with 4 arms: standard of care, biotin only, fibers only, biotin + fibers.
The 4 groups in the trial
- Arm 1: patient with usual follow-up (standard of care)Existing treatment, for comparison
receiving during 3 months before the surgery usual general dietary recommendations regarding balanced diet comprising legumes and fruits, meat or equivalent, dairy products and starch and bread
Treatment: Standard of care
- Arm 2: Same usual general dietary recommendations PLUS BiotinTreatment being tested
Patients will receive the same usual general dietary recommendations PLUS 1 capsule per day of Biotin 450 µg per day during 3 months before the surgery.
Treatment: Standard of care and Biotin supplement
- Arm 3: Same usual general dietary recommendations PLUS FiberTreatment being tested
Patients will receive the same usual general dietary recommendations PLUS 3 servings per day of PureLean® Fiber, a powdered blend of fibers and prebiotics, during 3 months before the surgery
Treatment: Standard of care and Fiber supplement
- Arm 4: Same usual general dietary recommendations PLUS Fiber PLUS BiotinTreatment being tested
Patients will receive the same usual general dietary recommendations PLUS 3 servings per day of PureLean® Fiber and Biotin 450 µg per day (1 capsule per day), during 3 months before the surgery.
Treatment: Standard of care, Biotin supplement, and Fiber supplement
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 15 January 2025