Fecal Microbiota Transplant Clinical Trial
Official title:
Assessing the Potential Role of the Gut Microbiome in Modulating Physical Abilities in Humans
There is a growing body of evidence indicating the significant contribution of the gut microbiome to host health and disease. Furthermore, it has been shown that exercise may modify the microbiome composition. The diversity of athletes' gut microbiome was found higher compared to gender and age-matched controls. However, important mechanistic questions related to the possible associations between exercise and the human gut microbiome remain unanswered. In this study, we propose to investigate using advanced state-of-the-art measurements of physical activity level and related metabolic parameters whether there is a connection between the microbiome and physical abilities in healthy participants and whether antibiotics consumption can influence host physical abilities and glycemic responses through changes induced in microbiome composition and function.
During all days of the study, participants will be connected to a continuous glucose monitor (CGM). In the second segment of the study, participants will be randomized into two groups: antibiotics or placebo, they will consume the pills for 7 days. In the third segment, participants will undergo a Fecal Microbiota Transplant/placebo administration. Subjects will be NPO at least 4 h before and for 1 hour following capsule intake, to minimize the risk of vomiting during ingestion of capsules. In the event of vomiting, patients will not be re-dosed. All patients will be evaluated after taking capsules by the study investigators and observed for 15 minutes. Phone follow up and assessment using open-ended questions and a standardized adverse event grading scale will take place 24-48hrs after the administration. Throughout the study, participants will collect stool and buccal samples which will be used for microbiota profiling. In study meetings, anthropometric measurements, medical history, GI symptoms questioner, blood samples, urine samples, and Dual X-ray absorptiometry (DXA) will be taken. Participants will also perform an extensive set of physical abilities test. ;
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