NCT05832190

Correcting GUT MicrobioTa by Combined Supplementation of FibERs and BIotiN to Improve Microbiome and Optimize Bariatric Surgery Outcomes

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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. 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.

Detailed description

This is a pilot open label study that aims to examine the efficacy of biotin supplementation with or without enriched soluble and insoluble fibers given during 3 months before the bariatric surgery, on gut microbiota composition and functional capacity to produce B vitamins (primary outcomes), compared to standard of care (e.g. patient preparation to bariatric surgery). The study is a 4-arm clinical trial: Arm 1: patients with usual follow-up (standard of care) 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 Arm 2: Same usual general dietary recommendations PLUS Biotin 450 µg per day (1 capsule per day) during 3 months before the surgery. Arm 3: 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 Arm 4: 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. There will be two periods: period 1 during the 3 months before bariatric surgery and period 3 after bariatric surgery (usual standard of care follow-up). The 4 groups will be compared before bariatric surgery and up to 6 months afterward Patients will receive a schedule of hospitalizations and visits before and after the surgery: * V0: 3 months before surgery * V1: presurgery visit, one day hospitalization * V2: 3 months post-surgery * V3: 6 months post-surgery * V4:12 months post-surgery At each visit (V0, V1, V2 , V3 and V4), will be performed as part of research: * Adipose tissue aspiration * Questionnaires * Fecal samples * Saliva samples (oral microbiota) * Blood samples * Urine samples This planning is part of the standard of care. The same follow-up will be performed in the 4 arms. Patients will be called 3 times between V0 and V1 by dietician as part of research.

Conditions

• Severe Obesity
• Metabolic Syndrome

Interventions

Type	Name	Description
OTHER	Standard of care	Patients 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
DIETARY_SUPPLEMENT	Biotin supplement	1 capsule per day of Biotin 450µg during 3 months before the surgery.
DIETARY_SUPPLEMENT	Fiber supplement	3 servings per day of PureLean® Fiber, a powdered blend of fibers and prebiotics, during 3 months before the surgery

Timeline

• Start date: 2023-07-24
• Primary completion: 2024-12-24
• Completion: 2024-12-24
• First posted: 2023-04-27
• Last updated: 2025-01-15

Locations

1 site across 1 country: France