Use of Probiotics to Aid in Weight Loss

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the success of daily supplementation of multiple probiotic bacterial cultures over 12 weeks in increasing the percentage of excess weight loss in the RNYGB (Gastric Bypass) weight loss population.

Detailed Description
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Hypothesis: The daily supplementation of a probiotic will increase weight loss compared to a placebo supplement in the post-operative gastric bypass patients. Study Design: All patients in this study will be scheduled to undergo the RNYGB (Gastric Bypass) procedure to assist in weight loss. Patients in this study will be randomized to one of two groups: Group 1 (Probiotics) or Group 2 (Placebo). Patients will begin supplementation at the beginning of their 4 week pre-surgery Optifast© 800 diet. All patients will take supplements for a total of 12 weeks. Nutritional education and support will be provided to each patient enrolled in the study. Weight loss will be measured using a machine that measures body composition. All patients will complete a quality of life questionnaire with regard to gastrointestinal health and a hair loss survey pre treatment and at the end of the study.

Official Title
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Use of Probiotics to Aid in Weight Loss

Conditions
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Weight Loss

Intervention / Treatment
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* Dietary Supplement: Probiotics
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female at least 18 years of age Signed informed consent Willingness to take a supplement once a day for 12 weeks Undergoing a RNYGB (gastric bypass) procedure Willingness to complete quality of life questionnaire and hair loss survey Exclusion Criteria: Pregnant Female Lactating Female Male or Female less than 18 years of age Patients on chronic antibiotic treatment (prescribed more than 2 courses of antibiotics over the 12 week study period) Patients who have demonstrated medical therapy non-compliance past or present

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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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>Patients treated with a probiotic (in capsule form) once daily for 12 weeks | Dietary Supplement: Probiotics<br>* The probiotic supplementation will use lactic acid bacteria in the ProbioMax DF™ supplement from Xymogen, Inc. This preparation consists of a four-strain probiotic with 100 billion CFU per vegetable capsule. The strains included are Lactobacillus acidophilus La-14, Bifidobacterium lactis HN019, Lactobacillus planarum Lp-115, and Bifidobacterium longum B1-05.<br>|
| Placebo Comparator: Placebo<br>Patients treated with a placebo (in capsule form) identical to that of the probiotic capsule once daily for 12 weeks | Dietary Supplement: Placebo<br>* The placebo supplementation is identical-looking to the capsule of the probiotic supplementation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of weight loss in post operative gastric bypass patients. | Percentage of weight loss will be measured using the The RJL Systems' Quantum IX on all patients for bioelectrical impedance analysis (BIA) to assess human body composition before beginning supplementation and at the end of the 12 week period. The Tanita system will be used as the back-up machine throughout the study as applicable. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of study medication (Probiotics vs. Placebo) on overall Gastrointestinal Health | Use of the validated quality of life survey: GIQOLI (Gastrointestinal Quality of Life Index) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight loss, Probiotics, Gastric Bypass