NCT05024188

Assessing the Potential Role of the Gut Microbiome in Modulating Physical Abilities in Humans

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Assaf Harofeh MC · Other Government
• Sex: All
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The intestinal microbiome is a microbial system that is influenced by host genetics and environmental exposures such as nutrition, stress and medications. 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. However, important mechanistic questions related to the possible associations between exercise and the human gut microbiome remain unanswered. In this study, the investigators are 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.

Detailed description

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, which will be consumed for 7 days. The third segment of the trial, participants will undergo an FMT/placebo administration for three consecutive days according to their randomization: participants who received antibiotics will receive FMT and participants who received placebo pills will receive placebo capsules in this segment as well. During the study, participants will collect stool and buccal samples which will be used for microbiota profiling. Furthermore, participants will undergo physical abilities test, anthropometric measurements, medical history questioners, blood and urine samples and Dual X-ray absorptiometry (DXA) test.

Conditions

• Physical Abilities
• FMT

Interventions

Type	Name	Description
DRUG	Antibiotics	Ciprofloxacin, 500 mg 2/day \& Metronidazole (Flagyl), 500 mg 3/day.
OTHER	Fecal Microbiota Transplantation	Fecal Microbiota Transplantation is the process of transferring stool from a healthy donor to another.
OTHER	Cellules Pills	7 days of cellules placebo pills.
OTHER	Agarose Capsules	Placebo capsules consist a combination of agarose in normal saline/glycerol (the same vehicle as in a FMT capsules)

Timeline

• Start date: 2022-01-20
• Primary completion: 2022-07-20
• Completion: 2023-01-20
• First posted: 2021-08-27
• Last updated: 2021-12-28