Probiotic Supplementation on Weight Loss
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|ClinicalTrials.gov Identifier: NCT03832439|
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : February 15, 2021
|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)|
|Estimated Enrollment :||40 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|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 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
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
|Contact: Vishakantha Murthy, PhD||507-255-8112||Murthy.Vishakantha@mayo.edu|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Vishakantha Murthy, PhD 507-255-8112 Murthy.Vishakantha@mayo.edu|
|Principal Investigator: Meera Shah, M.B., Ch.B|
|Principal Investigator:||Meera Shah, M.B., Ch.B||Mayo Clinic|