Probiotic Supplementation on Weight Loss

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Probiotic Supplementation on Weight Loss, and Its Association With the Gut Microbiome After Bariatric Surgery.

Conditions
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Bariatric Surgery Candidate

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: microcrystalline cellulose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic<br>This arm will be receiving probiotic supplements. | Dietary Supplement: Probiotic<br>* Lactobacillus rhamnosus GG 10 billion cells and microcrystalline cellulose<br>* Other names: Culturelle®;|
| Placebo Comparator: Placebo<br>This arm will be receiving placebo containing microcrystalline cellulose. | Dietary Supplement: microcrystalline cellulose<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotic, Microbiome