Use of Probiotics to Aid in Weight Loss

Not Applicable

Completed

• Conditions: Weight Loss
• Interventions: Dietary Supplement: Probiotics; Dietary Supplement: Placebo

• Registration Number: NCT01445704
• Lead Sponsor: Prisma Health-Upstate

Brief Summary

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

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 Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-09-29
• Study First Submitted QC: 2011-09-30
• Study First Posted: 2011-10-04
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of weight loss in post operative gastric bypass patients.	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Impact of study medication (Probiotics vs. Placebo) on overall Gastrointestinal Health	12 weeks	Use of the validated quality of life survey: GIQOLI (Gastrointestinal Quality of Life Index)

Trial Locations

Locations (1)

Greenville Hopsital System - Division of Bariatric and Minimal Access Surgery; 🇺🇸 Greenville, South Carolina, United States