Clinical trial NCT01445704: Use of Probiotics to Aid in Weight Loss
Official title: Use of Probiotics to Aid in Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: Weight loss
Probiotics
Gastric Bypass
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: Xymogen, Inc.
First posted: 2011-10-04
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of weight loss in post operative gastric bypass patients.
timeFrame: 12 weeks
Secondary outcomes:
measure: Impact of study medication (Probiotics vs. Placebo) on overall Gastrointestinal Health
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Greenville Hopsital System - Division of Bariatric and Minimal Access Surgery
state: South Carolina
Study officials:
affiliation: Prisma Health-Upstate
name: John D Scott, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Vanderhoof JA. Probiotics: future directions. Am J Clin Nutr. 2001 Jun;73(6):1152S-1155S. doi: 10.1093/ajcn/73.6.1152S.
citation: Kopp-Hoolihan L. Prophylactic and therapeutic uses of probiotics: a review. J Am Diet Assoc. 2001 Feb;101(2):229-38; quiz 239-41. doi: 10.1016/S0002-8223(01)00060-8.
citation: Woodard G.; Peraza J.; Downey J.; Encarnacion B.; Morton J. 343 Probiotics Improve Weight Loss, GI-Related Quality of Life and H2 Breath Tests After Gastric Bypass Surgery: A Prospective Randomized Trial. Gastroenterology. 2008 April; Vol. 134 (4), suppl. 1, pp. A-846.
citation: Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmulling C, Neugebauer E, Troidl H. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg. 1995 Feb;82(2):216-22. doi: 10.1002/bjs.1800820229.