Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT06252558
Brief Summary:
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.
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when conducting a literature review on probiotics/prebiotics, most of the research studies have poor quality and do not cite the quantity of each strain being studied.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.
Study:
NCT06252558
Study Brief:
Protocol Section:
NCT06252558