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
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|Condition or disease||Intervention/treatment||Phase|
|Bariatric Surgery Candidate||Dietary Supplement: Probiotic Dietary Supplement: microcrystalline cellulose||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|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|
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
- Weight loss [ Time Frame: 3 months ]Change in body weight from baseline to 3 months
- Visceral fat loss [ Time Frame: 3 months ]Change in visceral fat from baseline to 3 months
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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|
- All subjects who are > 18 and < 65 years of age recruited from the Mayo Clinic bariatric surgery clinic
- 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.
- Patients will be eligible if they are not on chronic antibiotic therapy and without active systemic illness.
- 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.
- Patients with allergy to antibiotics precluding the use of standard peri-operative antibiotics (cefazolin and metronidazole) will be excluded.
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
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Meera Shah, M.B., Ch.B||Mayo Clinic|
|Responsible Party:||Meera Shah, M.B., Ch.B., Principal Investigator, Mayo Clinic|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Body Weight Changes