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Probiotic Supplementation on Weight Loss

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03832439
Collaborator
(none)
18
Enrollment
1
Location
2
Arms
27.3
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators are trying to better understand how bariatric surgery leads to weight loss, and the role of bacteria that live in the gut in making this happen.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Probiotic
  • Dietary Supplement: microcrystalline cellulose
 N/A

Detailed Description

The investigators are interested in seeing how a probiotic, which is a dietary supplement containing large amounts of 'good' bacteria, can influence the make-up of the gut bacterial population and what effect it has on weight loss and loss of fat. Before undergoing weight loss surgery (sleeve gastrectomy or roux-en-y gastric bypass), study participants will be asked to provide a stool sample to assess the make-up of their gut bacterial population. They will also undergo a limited CT scan of the abdomen and DEXA (Xray) to help assess the amount of fat present inside the body.

After undergoing weight loss surgery (sleeve gastrectomy or roux-en-y gastric bypass), study participants will be given either a probiotic supplement or dummy pill (placebo) for 3 months, in addition to all usual care that occurs after surgery. The CT scan, DEXA scan and stool sample will be repeated at the end of the 3 month period and analyzed for changes.

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Probiotic Supplementation on Weight Loss, and Its Association With the Gut Microbiome After Bariatric Surgery.
Actual Study Start Date :
Jan 17, 2019
Actual Primary Completion Date :
Apr 28, 2021
Actual Study Completion Date :
Apr 28, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Probiotic

This arm will be receiving probiotic supplements.

Dietary Supplement: Probiotic
Lactobacillus rhamnosus GG 10 billion cells and microcrystalline cellulose
Other Names:
  • Culturelle®

    		•
    Placebo Comparator: Placebo

    This arm will be receiving placebo containing microcrystalline cellulose.

    Dietary Supplement: microcrystalline cellulose
    Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Weight loss [3 months]

      Change in body weight from baseline to 3 months

    2. Visceral fat loss [3 months]

      Change in visceral fat from baseline to 3 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. All subjects who are > 18 and < 65 years of age recruited from the Mayo Clinic bariatric surgery clinic

    2. Will also meet one of the National Institute of Health's criteria for bariatric surgery, i.e. body mass index (BMI) > 40 kg/m2 or BMI > 35 kg/m2 with significant weight-related comorbidities.

    3. Patients will be eligible if they are not on chronic antibiotic therapy and without active systemic illness.

    Exclusion Criteria:

    1. Patients with type 1 or 2 diabetes will be excluded due to the known pre-existing changes in the gut microbiome in this population. All patients will not have had exposure to probiotics, prebiotics or antibiotics in the preceding 4 weeks.

    2. Patients with allergy to antibiotics precluding the use of standard peri-operative antibiotics (cefazolin and metronidazole) will be excluded.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Meera Shah, M.B., Ch.B, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Meera Shah, M.B., Ch.B., Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03832439
    Other Study ID Numbers:
    • 16-003300
    First Posted:
    Feb 6, 2019
    Last Update Posted:
    Feb 21, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Meera Shah, M.B., Ch.B., Principal Investigator, Mayo Clinic
    Probiotic
    Microbiome
    Additional relevant MeSH terms:
    Weight Loss

    Study Results

    No Results Posted as of Feb 21, 2022