Status:

COMPLETED

Use of Probiotics to Aid in Weight Loss

Lead Sponsor:

Prisma Health-Upstate

Collaborating Sponsors:

Xymogen, Inc.

Conditions:

Weight Loss

Eligibility:

All Genders

18+ years

Phase:

NA

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 (Ga...

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 stu...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2014

Estimated Enrollment :

151 Patients enrolled

Trial Details

Trial ID

NCT01445704

Start Date

June 1 2010

End Date

January 1 2014

Last Update

April 9 2014

Active Locations (1)

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Greenville Hopsital System - Division of Bariatric and Minimal Access Surgery

Greenville, South Carolina, United States, 29607