Use of Probiotics to Aid in Weight Loss

This study has been completed.
Sponsor:
Collaborator:
Xymogen, Inc.
Information provided by (Responsible Party):
Greenville Hospital System University Medical Center
ClinicalTrials.gov Identifier:
NCT01445704
First received: September 29, 2011
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Weight Loss
Dietary Supplement: Probiotics
Dietary Supplement: Placebo

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Greenville Hospital System University Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Enrollment: 151
Study Start Date: June 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotics
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.
Other Name: Probiotics
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.
Other Name: Placebo

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01445704

Locations
United States, South Carolina
Greenville Hopsital System - Division of Bariatric and Minimal Access Surgery
Greenville, South Carolina, United States, 29607
Sponsors and Collaborators
Greenville Hospital System University Medical Center
Xymogen, Inc.
Investigators
Principal Investigator: John D Scott, M.D. Greenville Hospital System University Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Greenville Hospital System University Medical Center
ClinicalTrials.gov Identifier: NCT01445704     History of Changes
Other Study ID Numbers: Pro00006473
Study First Received: September 29, 2011
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Greenville Hospital System University Medical Center:
Weight loss
Probiotics
Gastric Bypass

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014