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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05024188
Enrollment
50
Registered
2021-08-27
Start date
2022-01-20
Completion date
2023-01-20
Last updated
2021-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

FMT, Physical Abilities

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.

Interventions

DRUGAntibiotics

Ciprofloxacin, 500 mg 2/day & Metronidazole (Flagyl), 500 mg 3/day.

OTHERFecal Microbiota Transplantation

Fecal Microbiota Transplantation is the process of transferring stool from a healthy donor to another.

OTHERCellules Pills

7 days of cellules placebo pills.

OTHERAgarose Capsules

Placebo capsules consist a combination of agarose in normal saline/glycerol (the same vehicle as in a FMT capsules)

Sponsors

Weizmann Institute of Science
CollaboratorOTHER
Assaf Harofeh MC
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Microbiome Profiling2 yearsCollection of stool and buccal samples samples for microbiome composition analysis with16s rRNA sequencing.
Body Mass Index (BMI)2 yearsThe 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 Circumferences2 yearswaist, hips, and limbs (cm).

Secondary

MeasureTime frameDescription
Glycemic Responses2 yearsPerforming continuous glucose monitor (CGM)
Bone Mineral Density (BMD)2 yearsUsing Dual X-ray absorptiometry (DXA) test

Contacts

Primary ContactIlan Youngster, Dr.
youngsteri@asaf.health.gov.il+972-50630119

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026