NCT01445704

Use of Probiotics to Aid in Weight Loss

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Prisma Health-Upstate · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Weight Loss

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	Placebo	The placebo supplementation is identical-looking to the capsule of the probiotic supplementation.

Timeline

• Start date: 2010-06-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2011-10-04
• Last updated: 2014-04-09

Locations

1 site across 1 country: United States