Symbiotic Use in Post-Bariatric Surgery Patients

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Description

The purpose of this double blind, randomized control trial would be to test the efficacy of a once daily, multi strain symbiotic on gut health changes in weight loss surgery patients by testing stool samples prior to administration and then three months post administration of the symbiotic to monitor any changes in bacteria in the stool samples. Study participants will also complete a survey that evaluates their bowel habits, stool consistency, and gastrointestinal related symptoms.

Targeted Conditions

Study Overview

Start Date
January 8, 2024
Completion Date
December 1, 2024
Enrollment
110
Date Posted
February 9, 2024
Accepts Healthy Volunteers?
Yes
Gender
All

Locations

Full Address
University of North Florida
Jacksonville, Florida 32224, United States

Eligibility

Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

12 months or greater post malabsorptive weight loss procedure

Exclusion Criteria:

LapBand or Intra-gastric balloon patients due to lack of surgical alteration to gut
Individuals who have not had an approved weight loss procedure
Individuals with impaired gastrointestinal function which would impair ingestion of oral supplement
Individuals with impaired gastrointestinal function which would impair ability to collect stool sample
Inability to comprehend and complete assessment tools
Inability to adhere to 90-day capsule supplement administration
Currently taking daily probiotic, prebiotic, or symbiotic supplement
Currently taking antibiotic treatment from physician

Study Contact Info

Study Contact Name
Samantha Stavola-Giaconia, MHA; Andrea Arikawa, PhD
Study Contact Phone

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
The topic of interest is the gut microbiome and the impact of symbiotics (prebiotics coupled with probiotics) on gut health after weight loss surgeries due to surgical alterations of the stomach and bowels as a result of the procedures. Symbiotics provide positive gut health benefits, ie. improvement in bowel function and reduction in gastrointestinal distress symptoms such as bloating. However, when conducting a literature review on probiotics/prebiotics, most of the research studies have poor quality and do not cite the quantity of each strain being studied. To date, no research has been conducted on symbiotic administration in post bariatric surgery patients and their relationship regarding improvements in gastrointestinal symptoms.

There is no standard dose recommended for probiotics. Each strain should be given at a dose that has shown to be effective at providing a health benefit to the host through clinical trials. However, no clear criteria has been established to determine what classifies as effective and what health benefits are considered clinically relevant. Most healthcare organizations recommend between 1 to 20 x 109 colony forming units (CFU)/ day for adults. In many cases, higher dosages have been shown to be more effective, but a clear dose-dependent response has not been identified and a "more is better" philosophy does not apply to all strains. Therefore, one rule states that "If a product contains multiple strains, then each strain should be present at levels of 109 to ensure effectiveness."

The primary objective of this study would be to determine the efficacy of symbiotic administration for improving gastrointestinal health in weight loss surgery patients. This study would test the efficacy of a once daily, multi strain symbiotic on gut health changes in weight loss surgery patients, twelve months or greater post-surgery, by testing stool samples prior to administration and then three months after administration of the symbiotic to monitor any changes in bacteria in the stool samples. Study participants will also complete a survey that evaluates their bowel habits, stool consistency, and gastrointestinal symptoms prior and post symbiotic administration.
NCTid (if applicable)
NCT06252558