Clinical trial NCT05024188: Assessing the Potential Role of the Gut Microbiome in Modulating Physical Abilities in Humans
Official title: Assessing the Potential Role of the Gut Microbiome in Modulating Physical Abilities in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Abilities
FMT
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Weizmann Institute of Science
First posted: 2021-08-27
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Microbiome Profiling
timeFrame: 2 years
measure: Body Mass Index (BMI)
timeFrame: 2 years
measure: Body Circumferences
timeFrame: 2 years
Secondary outcomes:
measure: Glycemic Responses
timeFrame: 2 years
measure: Bone Mineral Density (BMD)
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Assaf-Harofeh MC, Bee'r Yaakov Israel
name: Ilan Youngster, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clarke SF, Murphy EF, O'Sullivan O, Lucey AJ, Humphreys M, Hogan A, Hayes P, O'Reilly M, Jeffery IB, Wood-Martin R, Kerins DM, Quigley E, Ross RP, O'Toole PW, Molloy MG, Falvey E, Shanahan F, Cotter PD. Exercise and associated dietary extremes impact on gut microbial diversity. Gut. 2014 Dec;63(12):1913-20. doi: 10.1136/gutjnl-2013-306541. Epub 2014 Jun 9.
citation: Barton W, Penney NC, Cronin O, Garcia-Perez I, Molloy MG, Holmes E, Shanahan F, Cotter PD, O'Sullivan O. The microbiome of professional athletes differs from that of more sedentary subjects in composition and particularly at the functional metabolic level. Gut. 2018 Apr;67(4):625-633. doi: 10.1136/gutjnl-2016-313627. Epub 2017 Mar 30.