Does Weight Loss Surgery and Probiotic Supplementation Lead to a Lean Gut Microbiota?

Study Overview
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Brief Summary
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The purpose of the weight-loss study is to characterize the effect of LGG supplementation on the relative abundance of phyla in the gut microbiota of patients undergoing gastric bypass and sleeve gastrectomy surgery, and to elucidate a relationship between the gut microbiota pattern and the degree of weight-loss post-surgery. The investigators hypothesize that LGG administration will result in a leaner pattern of gut microbiota that will lead to higher weight loss at 3 months post-surgery.

Official Title
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Does Weight Loss Surgery and Probiotic Supplementation Lead to a Lean Gut Microbiota?

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Lactobacillus Rhamnosus GG
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 18 years Able to give informed consent and report on side effects Tolerating an oral/enteral diet Stable comorbid conditions Outpatient Exclusion Criteria: Inpatients Pregnancy (urine test done on all patients routinely pre-op)/ unwilling to comply with contraceptive requirement after gastric bypass surgery Known use of LGG or another probiotic (not including yogurt) within the previous 30 days Presence of an active bowel leak, acute abdomen, active intestinal disease, or significant bowel dysfunction Presence of an absolute neutrophil count less than 500 per cubic mm (must have had a Complete Blood Count within the last 6 months) or anticipation post chemotherapy that the absolute neutrophil count will fall below 500 per cubic mm. History of adverse reaction to product containing lactobacillus Active colitis (*see definition below) Known or suspected allergies to probiotics, lactobacillus, milk protein, or microcrystalline cellulose Structural heart disease, history of endocarditis or valve replacement, implanted cardiac device, congestive heart failure Positive baseline stool culture for LGG Recent or planned chemotherapy or radiation therapy Solid organ transplant within the prior year Stem cell transplant within the prior year On active immunosuppressive medication [anti-rejection, injectable immunosuppressive drugs for autoimmune disease, or corticosteroids (greater than ½ mg per kg body weight of prednisone or its equivalent) not including inhaled or topical steroids] Allergy or intolerance to or contraindication to two or more of the rescue antibiotic regimens (ampicillin, clindamycin, moxifloxacin) Participating in another clinical trial Uncontrolled psychiatric illness

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LGG Administration<br>Lactobacillus Rhamnosus GG (LGG) will be taken orally for 44 days. The daily dose is 2*10^10 organisms. The LGG is contained in capsules (1*10^10 organisms per capsule), and two capsules will be taken per day. | Dietary Supplement: Lactobacillus Rhamnosus GG<br>* LGG will be administered orally for 44 days<br>|
| Placebo Comparator: Placebo<br>Placebo to be taken orally for 44 days. | Dietary Supplement: Placebo<br>* placebo will be administered daily for 44 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Bacteria Phyla | We will specifically look at the percentages of different bacterial phyla in the stool and intestine | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric bypass, microbiota, probiotic