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Probiotic Supplementation on Weight Loss

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ClinicalTrials.gov Identifier: NCT03832439
Recruitment Status : Completed
First Posted : February 6, 2019
Last Update Posted : February 21, 2022
Sponsor:
Information provided by (Responsible Party):
Meera Shah, M.B., Ch.B., Mayo Clinic

Study Description
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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
Bariatric Surgery Candidate Dietary Supplement: Probiotic Dietary Supplement: microcrystalline cellulose Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : January 17, 2019
Actual Primary Completion Date : April 28, 2021
Actual Study Completion Date : April 28, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Culturelle®
Placebo Comparator: Placebo
This arm will be receiving placebo containing microcrystalline cellulose.
 Dietary Supplement: microcrystalline cellulose
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Weight loss [ Time Frame: 3 months ]
    Change in body weight from baseline to 3 months

  2. Visceral fat loss [ Time Frame: 3 months ]
    Change in visceral fat from baseline to 3 months


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832439


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Meera Shah, M.B., Ch.B Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Meera Shah, M.B., Ch.B., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03832439    
Other Study ID Numbers: 16-003300
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 21, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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., Mayo Clinic:
Probiotic
Microbiome
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight