Use of Probiotics to Aid in Weight Loss

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-01-31

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.

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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.

Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotics

Patients treated with a probiotic (in capsule form) once daily for 12 weeks

Group Type EXPERIMENTAL

Probiotics

Intervention Type DIETARY_SUPPLEMENT

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.

Placebo

Patients treated with a placebo (in capsule form) identical to that of the probiotic capsule once daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

The placebo supplementation is identical-looking to the capsule of the probiotic supplementation.

Interventions

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Probiotics

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

The placebo supplementation is identical-looking to the capsule of the probiotic supplementation.

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes