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

Not Applicable

• Conditions: Physical Abilities; FMT
• Interventions: Drug: Antibiotics; Other: Cellules Pills; Other: Fecal Microbiota Transplantation; Other: Agarose Capsules

• Registration Number: NCT05024188
• Lead Sponsor: Assaf Harofeh MC

Brief 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.

Study Timeline

• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-22
• Study First Posted: 2021-08-27
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-27
• Last Update Posted: 2021-12-28
• Study Start: 2022-01-20
• Primary Completion: 2022-07-20
• Study Completion: 2023-01-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• BMI<28
• Age - 20-35
• Are used to exercise in aerobic sports (running, swimming, Zumba, ball games, functional training, surfing, tennis, wrestling ext.).
• Exercise at least twice a week, for a minimum duration of the last 6 months.

Exclusion Criteria

• Consumption of antibiotics (PO) or probiotics 3 months prior to the first day of the experiment.
• Diagnosis of type 1 or type 2 diabetes.
• Pregnancy, fertility treatments, breastfeeding women six months prior to enrollment and during the study.
• Chronic disease (e.g. AIDS, Cushing syndrome, CKD, acromegaly, hyperthyroidism etc.)
• Cancer and recent anticancer treatment
• Psychiatric disorders
• Coagulation disorders
• Gastrointestinal disorders
• Bariatric surgery
• Alcohol or substance abuse
• BMI>28
• Any physical condition precluding the completion of a routine effort test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotics + FMT	Antibiotics	7 days of antibiotics- Ciprofloxacin, 500 mg 2/day \& Metronidazole (Flagyl), 500 mg 3/day. After antibiotics administration, participants will receive 10 aFMT capsules for three consecutive days (a total of 30 capsules).
Antibiotics + FMT	Fecal Microbiota Transplantation	7 days of antibiotics- Ciprofloxacin, 500 mg 2/day \& Metronidazole (Flagyl), 500 mg 3/day. After antibiotics administration, participants will receive 10 aFMT capsules for three consecutive days (a total of 30 capsules).
Placebo	Cellules Pills	7 days of cellules pills. After cellules pills administration, participants will receive 10 agarose capsules for three consecutive days (a total of 30 capsules).
Placebo	Agarose Capsules	7 days of cellules pills. After cellules pills administration, participants will receive 10 agarose capsules for three consecutive days (a total of 30 capsules).

Primary Outcome Measures

Name	Time	Method
Microbiome Profiling	2 years	Collection of stool and buccal samples samples for microbiome composition analysis with16s rRNA sequencing.
Body Mass Index (BMI)	2 years	The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m\^2
Body Circumferences	2 years	waist, hips, and limbs (cm).

Secondary Outcome Measures

Name	Time	Method
Glycemic Responses	2 years	Performing continuous glucose monitor (CGM)
Bone Mineral Density (BMD)	2 years	Using Dual X-ray absorptiometry (DXA) test