Use of Probiotics to Aid in Weight Loss

Weight Loss Clinical Trial

— Probiotics  

Official title:

Use of Probiotics to Aid in Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01445704
• Other study ID #: Pro00006473
• Status: Completed
• Phase: N/A
• First received: September 29, 2011
• Last updated: April 8, 2014
• Start date: June 2010
• Est. completion date: January 2014

Study information

• Verified date: April 2014
• Source: Greenville Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

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
The placebo supplementation is identical-looking to the capsule of the probiotic supplementation.

Locations

Country	Name	City	State
United States	Greenville Hopsital System - Division of Bariatric and Minimal Access Surgery	Greenville	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Greenville Health System	Xymogen, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (5)

Anderson JW, Gilliland SE. Effect of fermented milk (yogurt) containing Lactobacillus acidophilus L1 on serum cholesterol in hypercholesterolemic humans. J Am Coll Nutr. 1999 Feb;18(1):43-50. — View Citation

Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmülling 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. — View 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. Review. — View Citation

Vanderhoof JA. Probiotics: future directions. Am J Clin Nutr. 2001 Jun;73(6):1152S-1155S. Review. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of weight loss in post operative gastric bypass patients.	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.	12 weeks	No
Secondary	Impact of study medication (Probiotics vs. Placebo) on overall Gastrointestinal Health	Use of the validated quality of life survey: GIQOLI (Gastrointestinal Quality of Life Index)	12 weeks	No

External Links

•   Center for Disease Control and Prevention