Use of Probiotics to Aid in Weight Loss

Prisma Health-Upstate151 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

151

Conditions

Weight Loss

Interventions

ProbioticsDIETARY_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.

PlaceboDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Greenville Hopsital System - Division of Bariatric and Minimal Access Surgery

Greenville, South Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Secondary Outcomes

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)

Time frame: 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.