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

September 29, 2011
April 8, 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 ] [ 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.
Same as current
Complete list of historical versions of study NCT01445704 on ClinicalTrials.gov Archive Site
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)
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.
    Other Name: Probiotics
  • Dietary Supplement: Placebo
    The placebo supplementation is identical-looking to the capsule of the probiotic supplementation.
    Other Name: Placebo
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
151
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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01445704
Pro00006473
No
Greenville Hospital System University Medical Center
Greenville Hospital System University Medical Center
Xymogen, Inc.
Principal Investigator: John D Scott, M.D. Greenville Hospital System University Medical Center
Greenville Hospital System University Medical Center
April 2014

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