Use of Probiotics to Aid in Weight Loss (Probiotics)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01445704|
Recruitment Status : Completed
First Posted : October 4, 2011
Last Update Posted : April 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Weight Loss||Dietary Supplement: Probiotics Dietary Supplement: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Use of Probiotics to Aid in Weight Loss|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
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.
- Percentage of weight loss in post operative gastric bypass patients. [ Time Frame: 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.
- Impact of study medication (Probiotics vs. Placebo) on overall Gastrointestinal Health [ Time Frame: 12 weeks ]Use of the validated quality of life survey: GIQOLI (Gastrointestinal Quality of Life Index)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.||Prisma Health-Upstate|