Use of Probiotics to Aid in Weight Loss
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Prisma Health-Upstate
- Enrollment
- 151
- Locations
- 1
- Primary Endpoint
- Percentage of weight loss in post operative gastric bypass patients.
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Probiotics
Patients treated with a probiotic (in capsule form) once daily for 12 weeks
Intervention: Probiotics (Dietary Supplement)
Placebo
Patients treated with a placebo (in capsule form) identical to that of the probiotic capsule once daily for 12 weeks
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
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
- Impact of study medication (Probiotics vs. Placebo) on overall Gastrointestinal Health(12 weeks)