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

Assaf Harofeh MC

Status: Unknown

Conditions: FMT; Physical Abilities

Treatments: Other: Agarose Capsules; Other: Cellules Pills; Drug: Antibiotics; Other: Fecal Microbiota Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05024188

0277-19-ASF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Antibiotics + FMT

Experimental group

Description:

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).

Treatment:

Other: Fecal Microbiota Transplantation

Drug: Antibiotics

Placebo

Placebo Comparator group

Description:

7 days of cellules pills. After cellules pills administration, participants will receive 10 agarose capsules for three consecutive days (a total of 30 capsules).

Treatment:

Other: Cellules Pills

Other: Agarose Capsules