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

NCT05832190 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-01-15

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-24
Primary Completion
2024-12-24
Completion
2024-12-24

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05832190 on ClinicalTrials.gov