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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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FMT, Physical Abilities

Intervention / Treatment
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* Drug: Antibiotics
* Other: Fecal Microbiota Transplantation
* Other: Cellules Pills
* Other: Agarose Capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antibiotics + FMT<br>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). | Drug: Antibiotics<br>* Ciprofloxacin, 500 mg 2/day & Metronidazole (Flagyl), 500 mg 3/day.<br>* Other names: Ciprofloxacin & Metronidazole;Other: Fecal Microbiota Transplantation<br>* Fecal Microbiota Transplantation is the process of transferring stool from a healthy donor to another.<br>* Other names: FMT;|
| Placebo Comparator: Placebo<br>7 days of cellules pills. After cellules pills administration, participants will receive 10 agarose capsules for three consecutive days (a total of 30 capsules). | Other: Cellules Pills<br>* 7 days of cellules placebo pills.<br>Other: Agarose Capsules<br>* Placebo capsules consist a combination of agarose in normal saline/glycerol (the same vehicle as in a FMT capsules)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome Profiling | Collection of stool and buccal samples samples for microbiome composition analysis with16s rRNA sequencing. | 2 years | 
| Body Mass Index (BMI) | 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 | 2 years | 
| Body Circumferences | waist, hips, and limbs (cm). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Responses | Performing continuous glucose monitor (CGM) | 2 years | 
| Bone Mineral Density (BMD) | Using Dual X-ray absorptiometry (DXA) test | 2 years |