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Completed

NCT Number: NCT01445704

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.

Completed

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Greenville Hopsital System - Division of Bariatric and Minimal Access Surgery

Greenville, South Carolina, 29607, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotics

Dietary Supplement

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

Dietary Supplement

The placebo supplementation is identical-looking to the capsule of the probiotic supplementation.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Collaborators

  • Xymogen, Inc.

Registry information

Acronym: Probiotics

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 4, 2011
Registry last updated
Apr 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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