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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Active Comparator | This arm will be receiving probiotic supplements. |
|
| Placebo | Placebo Comparator | This arm will be receiving placebo containing microcrystalline cellulose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Lactobacillus rhamnosus GG 10 billion cells and microcrystalline cellulose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | Change in body weight from baseline to 3 months | 3 months |
| Visceral fat loss | Change in visceral fat from baseline to 3 months | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meera Shah, M.B., Ch.B | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| C109691 | microcrystalline cellulose |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| microcrystalline cellulose | Dietary Supplement | Placebo |
|
| D019602 |
| Food and Beverages |