An interventional study of Symbiotic and Placebo in Bariatric Surgery Candidate, sponsored by University of North Florida. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by University of North Florida · Not applicable, Interventional, and Treatment
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.
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when conducting a literature review on probiotics/prebiotics, most of the research studies have poor quality and do not cite the quantity of each strain being studied.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.
University of North Florida is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
An over-the counter, once daily symbiotic capsule including: 15 billion CFU probiotic blend and 250mg of prebiotic.
Dietary Supplement: Symbiotic
Once daily capsule of microcrystalline cellulose.
Dietary Supplement: Placebo
One-a-day administration of a capsule supplement containing:15 billion CFU probiotic blend (Lactobacillus acidophilus La-14, Bifidobacterium longum BB536, Lactobacillus acidophilus NCFM, Lactobacillus rhamnosus GG, Lactobacillus gasseri Lg-36) and 250mg of chicory root inulin.
Also known as: Celebrate Balance Probiotic Plus Prebiotic
Daily fiber capsule containing microcrystalline cellulose
Symbiotic Changes in Stool Samples
The primary objective will 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 after administration of a symbiotic or placebo. Chi-square tests will be performed to show associations between symbiotic intake and stool bacteria diversity and concentrations.
Time frame: 90 days
Bristol Stool Scale Weekly Changes
Participants will complete a weekly Bristol Stool Scale that identifies their overall stool consistency for the week.Participants will complete this tool weekly and SPSS software will be used to conduct an independent t-test of mean changes to evaluate the difference in stool form. Total scores can range from 7 through 49, with scores closest to 24.5 representing normal stool form. The comparisons of these tests will be able to provide statistical relevance on the usage of symbiotic supplementation in normal stool form.
Time frame: 12 weeks
Frequency of Weekly Stools
Participants will complete a weekly survey that identifies the amount of stools produced the week prior. Independent t-test will be performed to show changes in stool frequency.
Time frame: 12 weeks
Gastrointestinal Related Symptoms
A final Chi-square test of association will be performed using SPSS software to test whether there is a relationship between symbiotic intake and reduction in GI related symptoms. P-values of 0.05 or lower will be used to prove statistical significance for all tests performed.
Time frame: 12 weeks
Plan to share: Undecided
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University of North Florida