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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. Identifier: NCT01445704
Recruitment Status : Completed
First Posted : October 4, 2011
Last Update Posted : April 9, 2014
Xymogen, Inc.
Information provided by (Responsible Party):
Prisma Health-Upstate

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.

Condition or disease Intervention/treatment Phase
Weight Loss Dietary Supplement: Probiotics Dietary Supplement: Placebo Not Applicable

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01445704

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United States, South Carolina
Greenville Hopsital System - Division of Bariatric and Minimal Access Surgery
Greenville, South Carolina, United States, 29607
Sponsors and Collaborators
Prisma Health-Upstate
Xymogen, Inc.
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Principal Investigator: John D Scott, M.D. Prisma Health-Upstate

Additional Information:
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Responsible Party: Prisma Health-Upstate Identifier: NCT01445704     History of Changes
Other Study ID Numbers: Pro00006473
First Posted: October 4, 2011    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014

Keywords provided by Prisma Health-Upstate:
Weight loss
Gastric Bypass

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