Assessing the Potential Role of the Gut Microbiome in Modulating Physical Abilities in Humans
NCT ID: NCT05024188
Last Updated: 2021-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2022-01-20
2023-01-20
Brief Summary
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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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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Antibiotics + FMT
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).
Antibiotics
Ciprofloxacin, 500 mg 2/day \& Metronidazole (Flagyl), 500 mg 3/day.
Fecal Microbiota Transplantation
Fecal Microbiota Transplantation is the process of transferring stool from a healthy donor to another.
Placebo
7 days of cellules pills. After cellules pills administration, participants will receive 10 agarose capsules for three consecutive days (a total of 30 capsules).
Cellules Pills
7 days of cellules placebo pills.
Agarose Capsules
Placebo capsules consist a combination of agarose in normal saline/glycerol (the same vehicle as in a FMT capsules)
Interventions
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Antibiotics
Ciprofloxacin, 500 mg 2/day \& Metronidazole (Flagyl), 500 mg 3/day.
Fecal Microbiota Transplantation
Fecal Microbiota Transplantation is the process of transferring stool from a healthy donor to another.
Cellules Pills
7 days of cellules placebo pills.
Agarose Capsules
Placebo capsules consist a combination of agarose in normal saline/glycerol (the same vehicle as in a FMT capsules)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
35 Years
ALL
Yes
Sponsors
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Weizmann Institute of Science
OTHER
Assaf Harofeh MC
OTHER_GOV
Responsible Party
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Assaf Harofeh MC
Principal Investigator
Principal Investigators
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Ilan Youngster, Dr.
Role: PRINCIPAL_INVESTIGATOR
Assaf-Harofeh MC, Bee'r Yaakov Israel
Central Contacts
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References
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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.
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.
Other Identifiers
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0277-19-ASF
Identifier Type: -
Identifier Source: org_study_id
NCT04707222
Identifier Type: -
Identifier Source: nct_alias