Assessing the Potential Role of the Gut Microbiome in Modulating Physical Abilities in Humans
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2021
CompletedFirst Posted
Study publicly available on registry
August 27, 2021
CompletedStudy Start
First participant enrolled
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2023
CompletedDecember 28, 2021
December 1, 2021
6 months
August 4, 2021
December 27, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Glycemic Responses
2 years
Bone Mineral Density (BMD)
2 years
Study Arms (2)
Antibiotics + FMT
EXPERIMENTAL7 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
PLACEBO COMPARATOR7 days of cellules pills. After cellules pills administration, participants will receive 10 agarose capsules for three consecutive days (a total of 30 capsules).
Interventions
Ciprofloxacin, 500 mg 2/day \& Metronidazole (Flagyl), 500 mg 3/day.
Fecal Microbiota Transplantation is the process of transferring stool from a healthy donor to another.
Placebo capsules consist a combination of agarose in normal saline/glycerol (the same vehicle as in a FMT capsules)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assaf Harofeh MClead
- Weizmann Institute of Sciencecollaborator
Related Publications (2)
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.
PMID: 25021423BACKGROUNDBarton 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.
PMID: 28360096BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ilan Youngster, Dr.
Assaf-Harofeh MC, Bee'r Yaakov Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 4, 2021
First Posted
August 27, 2021
Study Start
January 20, 2022
Primary Completion
July 20, 2022
Study Completion
January 20, 2023
Last Updated
December 28, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share