Use of Probiotics to Aid in Weight Loss

Prisma Health-Upstate

Status: Completed

Conditions: Weight Loss

Treatments: Dietary Supplement: Probiotics; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01445704

Pro00006473

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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151 participants in 2 patient groups, including a placebo group

Probiotics

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotics

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo