Use of Probiotics to Aid in Weight Loss (Probiotics)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Use of Probiotics to Aid in Weight Loss|
- Percentage of weight loss in post operative gastric bypass patients. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
- Impact of study medication (Probiotics vs. Placebo) on overall Gastrointestinal Health [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Use of the validated quality of life survey: GIQOLI (Gastrointestinal Quality of Life Index)
|Study Start Date:||June 2010|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Patients treated with a probiotic (in capsule form) once daily for 12 weeks
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.
Placebo Comparator: Placebo
Patients treated with a placebo (in capsule form) identical to that of the probiotic capsule once daily for 12 weeks
Dietary Supplement: Placebo
The placebo supplementation is identical-looking to the capsule of the probiotic supplementation.
The daily supplementation of a probiotic will increase weight loss compared to a placebo supplement in the post-operative gastric bypass patients.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445704
|United States, South Carolina|
|Greenville Hopsital System - Division of Bariatric and Minimal Access Surgery|
|Greenville, South Carolina, United States, 29607|
|Principal Investigator:||John D Scott, M.D.||Greenville Health System|