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):
Greenville Health System

September 29, 2011
October 4, 2011
April 9, 2014
June 2010
January 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01445704 on Archive Site
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)
Same as current
Not Provided
Not Provided
Use of Probiotics to Aid in Weight Loss
Use of Probiotics to Aid in Weight Loss
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.


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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Weight Loss
  • 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.
  • Dietary Supplement: Placebo
    The placebo supplementation is identical-looking to the capsule of the probiotic supplementation.
  • Experimental: Probiotics
    Patients treated with a probiotic (in capsule form) once daily for 12 weeks
    Intervention: Dietary Supplement: Probiotics
  • Placebo Comparator: Placebo
    Patients treated with a placebo (in capsule form) identical to that of the probiotic capsule once daily for 12 weeks
    Intervention: Dietary Supplement: Placebo

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2014
January 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Greenville Health System
Greenville Health System
Xymogen, Inc.
Principal Investigator: John D Scott, M.D. Greenville Health System
Greenville Health System
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP