Use of Probiotics to Aid in Weight Loss

NCT01445704 | Completed

• 1 other identifier: Pro00006473
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss

Keywords

Weight loss; Probiotics; Gastric Bypass

Outcome Measures

Primary Outcomes (1)

• Percentage of weight loss in post operative gastric bypass patients.

  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.

  12 weeks

Secondary Outcomes (1)

• Impact of study medication (Probiotics vs. Placebo) on overall Gastrointestinal Health

  12 weeks

Study Arms (2)

Probiotics

EXPERIMENTAL

Patients treated with a probiotic (in capsule form) once daily for 12 weeks

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

Patients treated with a placebo (in capsule form) identical to that of the probiotic capsule once daily for 12 weeks

Dietary Supplement: Placebo

Interventions

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.

Probiotics

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• Xymogen, Inc.: collaborator

Study Sites (1)

Greenville Hopsital System - Division of Bariatric and Minimal Access Surgery

Greenville, South Carolina, 29607, United States

Location

Related Publications (5)

• Anderson JW, Gilliland SE. Effect of fermented milk (yogurt) containing Lactobacillus acidophilus L1 on serum cholesterol in hypercholesterolemic humans. J Am Coll Nutr. 1999 Feb;18(1):43-50. doi: 10.1080/07315724.1999.10718826.

  PMID: 10067658 BACKGROUND

• Vanderhoof JA. Probiotics: future directions. Am J Clin Nutr. 2001 Jun;73(6):1152S-1155S. doi: 10.1093/ajcn/73.6.1152S.

  PMID: 11393194 BACKGROUND

• Kopp-Hoolihan L. Prophylactic and therapeutic uses of probiotics: a review. J Am Diet Assoc. 2001 Feb;101(2):229-38; quiz 239-41. doi: 10.1016/S0002-8223(01)00060-8.

  PMID: 11271697 BACKGROUND

• Woodard G.; Peraza J.; Downey J.; Encarnacion B.; Morton J. 343 Probiotics Improve Weight Loss, GI-Related Quality of Life and H2 Breath Tests After Gastric Bypass Surgery: A Prospective Randomized Trial. Gastroenterology. 2008 April; Vol. 134 (4), suppl. 1, pp. A-846.

  BACKGROUND

• Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmulling C, Neugebauer E, Troidl H. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg. 1995 Feb;82(2):216-22. doi: 10.1002/bjs.1800820229.

  PMID: 7749697 BACKGROUND

MeSH Terms

Conditions

Weight Loss

Interventions

Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• John D Scott, M.D.

  Prisma Health-Upstate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: October 4, 2011
• Study Start: June 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 9, 2014

Record last verified: 2014-04

Locations

US (1)