Physical AbilitiesNCT05024188
Assessing the Potential Role of the Gut Microbiome in Modulating Physical Abilities in Humans
A study testing Antibiotics, Autologous Fecal Microbiota Transplantation and Cellules Pills in people with Physical Abilities and FMT, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Abilities, FMT
- What is being tested?
- Antibiotics, Autologous Fecal Microbiota Transplantation and Cellules Pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 29 Jun 2022to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age - 20-55
- 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.
Who cannot join
- 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-under the discretion of the study medical team (e.g. AIDS, Cushing syndrome, Chronic kidney disease (CKD), acromegaly, hyperthyroidism etc.)
- Cancer and recent anticancer treatment
- Psychiatric disorders
Show all 12Show fewer
- Coagulation disorders
- Gastrointestinal disorders
- Bariatric surgery
- Alcohol or substance abuse
- Any physical condition precluding the completion of a routine effort test
- Allergy to Flagyl (Metronidazole) and/ or Ciprodex (Ciprofloxacin)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Weizmann Institute of Science
Rehovot
Shimrit Eliyahu Miller, 08-9529089, shimrit.miller@weizmann.ac.il
About this study
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.
Read the detailed description
In this interventional study participants will be followed by researchers for up to 1 month. During all days of the study participants will be connected to a continuous glucose monitor (CGM). During the study, participants will collect stool and buccal samples which will be used for microbiota profiling. Participants will receive kits in advance to collect the stool, and oral sample at home. Additionally, participants will receive a Smartwatch to track their physical activity performance.
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 be allocated into three groups, to receive either 15 Autologous fecal microbiota transplantation (aFMT) capsules or 15 identical placebo capsules (participants who received antibiotics will be divided into 2 groups to receive fecal microbiota transplantation (FMT) or placebo, and participants who received placebo will receive placebo in this segment as well). The FMT will take place for two consecutive days (a total of 30 capsules).
On the fourth meeting After all tests are done, participants who received antibiotic and haven't received aFMT will undergo an FMT administration (on meetings 4-5). The FMT will take place on two consecutive days (a total of 30 capsules) in the same manner it was described above. The other 2 groups will receive a placebo capsules as described above.
Participants will undergo physical abilities tests (VO2max test, muscle strength will be valued with "System 4 Pro™ BIODEX " or a manual dynamometer, high jumps, 30 seconds jumps, flexibility. Before, immediately after, and following 1,3, 5, 7 and 9 minutes of the 30 seconds jumps, finger prick blood samples will be taken for lactate measurement), anthropometric measurements, medical history questioners, blood samples and body composition using DXA.
All adverse events will be documented and reported as necessary to the study doctor and the ethical committee.
An additional cohort of 18 days (group b) will be recruited in order to examine the role of the gut microbiome in contributing to exercise capacity, particularly through D-lactate generation.
Participants will be asked to perform cycles of 4-minute efforts, increasing capacity by 10-15% per stage. Blood lactate at the end of each stage will be collected. Cycles will stop once the participant reached their lactate threshold, monitered by the finger prick lactate measurement and or if the participant cannot sustain the workload. Similarly to the first cohort, participants will be randomized to receive either antibiotics or placebo. Participants in the antibiotics arm will receive their aFMT to restore their pre-antibiotic gut microbiome, by ingesting 30 pills of FMT, and the placebo group will receive 30 pills of Cellulose.
- Conditions
- Physical Abilities, FMT
- Being tested
- Antibiotics, Autologous Fecal Microbiota Transplantation, Cellules Pills, placebo capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticsDrug
Also called Ciprofloxacin & Metronidazole
Ciprofloxacin, 500 mg 2/day \& Metronidazole (Flagyl), 500 mg 3/day.
Autologous Fecal Microbiota TransplantationOther
Also called FMT
Autologous Fecal Microbiota Transplantation( aFMT( stool taken from the participant, prior to antibiotic treatment)
Cellules PillsOther
7 days of cellules placebo pills.
placebo capsulesOther
Placebo capsules consist of saline/glycerol (the same vehicle as in a FMT capsules)
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics + FMT | Experimental | 7 days of antibiotics- Ciprofloxacin, 500 mg 2/day \& Metronidazole (Flagyl), 500 mg 3/day. After antibiotics administration, participants will receive 15 aFMT capsules for two consecutive days (a total of 30 capsules). On the forth + fifth meeting, participants who received antibiotic FMT will receive a 30 placebo capsules Receives: Drug: Antibiotics; Other: Autologous Fecal Microbiota Transplantation; Other: placebo capsules |
| Placebo | Placebo comparator | 7 days of placebo cellulose pills. After cellulose pills administration, participants will receive 15 placebo capsules for two consecutive days (a total of 30 capsules).
On the forth + fifth meeting, the participants will again receive 30 placebo capsules. Receives: Other: Cellules Pills; Other: placebo capsules |
| Antibiotics+placebo | Experimental | 7 days of antibiotics- Ciprofloxacin, 500 mg 2/day \& Metronidazole (Flagyl), 500 mg 3/day. After antibiotics administration participants will receive 15 placebo capsules. On the forth + fifth meeting the participants will receive 15 aFMT capsules for two consecutive days (a total of 30 capsules). Receives: Drug: Antibiotics; Other: Autologous Fecal Microbiota Transplantation; Other: placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome Profiling
Using stool and buccal samples for microbiome composition analysis
Measured: 1 month
Physical ability
will be measured by several tests: flexibility, Biodex, maximal oxygen uptake (VO2 max), high jumps, 30 seconds jumps, lactate measurement.
Measured: 1 month
Secondary outcomes (1)
Glycemic Responses
Performing continuous glucose monitor (CGM)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start29 Jun 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical AbilitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- Weizmann Institute of Science, Wingate Institute
- Responsible party
- Principal investigator, Ilan Youngster, Assaf-Harofeh Medical Center
- Investigators
- Ilan Youngster, Dr., Principal investigator, Assaf-Harofeh MC, Bee'r Yaakov Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024188
- Sponsor's protocol ID
- 0277-19-ASF
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25021423Barton 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.
PubMed 28360096
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Potential Role of the Gut Microbiome in Modulating Physical Abilities in Humans
- ClinicalTrials.gov ID
- NCT05024188
- Acronym / sponsor ID
- 0277-19-ASF
- Conditions
- Physical Abilities, FMT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- Weizmann Institute of Science, Wingate Institute
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
In this interventional study participants will be followed by researchers for up to 1 month. During all days of the study participants will be connected to a continuous glucose monitor (CGM). During the study, participants will collect stool and buccal samples which will be used for microbiota profiling. Participants will receive kits in advance to collect the stool, and oral sample at home. Additionally, participants will receive a Smartwatch to track their physical activity performance.
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 be allocated into three groups, to receive either 15 Autologous fecal microbiota transplantation (aFMT) capsules or 15 identical placebo capsules (participants who received antibiotics will be divided into 2 groups to receive fecal microbiota transplantation (FMT) or placebo, and participants who received placebo will receive placebo in this segment as well). The FMT will take place for two consecutive days (a total of 30 capsules).
On the fourth meeting After all tests are done, participants who received antibiotic and haven't received aFMT will undergo an FMT administration (on meetings 4-5). The FMT will take place on two consecutive days (a total of 30 capsules) in the same manner it was described above. The other 2 groups will receive a placebo capsules as described above.
Participants will undergo physical abilities tests (VO2max test, muscle strength will be valued with "System 4 Pro™ BIODEX " or a manual dynamometer, high jumps, 30 seconds jumps, flexibility. Before, immediately after, and following 1,3, 5, 7 and 9 minutes of the 30 seconds jumps, finger prick blood samples will be taken for lactate measurement), anthropometric measurements, medical history questioners, blood samples and body composition using DXA.
All adverse events will be documented and reported as necessary to the study doctor and the ethical committee.
An additional cohort of 18 days (group b) will be recruited in order to examine the role of the gut microbiome in contributing to exercise capacity, particularly through D-lactate generation.
Participants will be asked to perform cycles of 4-minute efforts, increasing capacity by 10-15% per stage. Blood lactate at the end of each stage will be collected. Cycles will stop once the participant reached their lactate threshold, monitered by the finger prick lactate measurement and or if the participant cannot sustain the workload. Similarly to the first cohort, participants will be randomized to receive either antibiotics or placebo. Participants in the antibiotics arm will receive their aFMT to restore their pre-antibiotic gut microbiome, by ingesting 30 pills of FMT, and the placebo group will receive 30 pills of Cellulose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Antibiotics + FMT | Experimental | Drug: Antibiotics, Other: Autologous Fecal Microbiota Transplantation, Other: placebo capsules7 days of antibiotics- Ciprofloxacin, 500 mg 2/day \& Metronidazole (Flagyl), 500 mg 3/day. After antibiotics administration, participants will receive 15 aFMT capsules for two consecutive days (a total of 30 capsules). On the forth + fifth meeting, participants who received antibiotic FMT will receive a 30 placebo capsules |
| Placebo | Placebo comparator | Other: Cellules Pills, Other: placebo capsules7 days of placebo cellulose pills. After cellulose pills administration, participants will receive 15 placebo capsules for two consecutive days (a total of 30 capsules). On the forth + fifth meeting, the participants will again receive 30 placebo capsules. |
| Antibiotics+placebo | Experimental | Drug: Antibiotics, Other: Autologous Fecal Microbiota Transplantation, Other: placebo capsules7 days of antibiotics- Ciprofloxacin, 500 mg 2/day \& Metronidazole (Flagyl), 500 mg 3/day. After antibiotics administration participants will receive 15 placebo capsules. On the forth + fifth meeting the participants will receive 15 aFMT capsules for two consecutive days (a total of 30 capsules). |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age - 20-55
- 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.
Key exclusion criteria (12 listed)
- 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-under the discretion of the study medical team (e.g. AIDS, Cushing syndrome, Chronic kidney disease (CKD), acromegaly, hyperthyroidism etc.)
- Cancer and recent anticancer treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticsAlso: Ciprofloxacin & MetronidazoleCiprofloxacin, 500 mg 2/day \& Metronidazole (Flagyl), 500 mg 3/day. | Drug | Antibiotics + FMT, Antibiotics+placebo |
| Autologous Fecal Microbiota TransplantationAlso: FMTAutologous Fecal Microbiota Transplantation( aFMT( stool taken from the participant, prior to antibiotic treatment) | Other | Antibiotics + FMT, Antibiotics+placebo |
| Cellules Pills7 days of cellules placebo pills. | Other | Placebo |
| placebo capsulesPlacebo capsules consist of saline/glycerol (the same vehicle as in a FMT capsules) | Other | Antibiotics + FMT, Antibiotics+placebo, Placebo |
Primary outcome
Microbiome Profiling
Time frame: 1 month
Using stool and buccal samples for microbiome composition analysis
Physical ability
Time frame: 1 month
will be measured by several tests: flexibility, Biodex, maximal oxygen uptake (VO2 max), high jumps, 30 seconds jumps, lactate measurement.
1 secondary outcome
Glycemic Responses
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 25021423Clarke 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.
- Background: PubMed 28360096Barton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ilan Youngster, Dr. principal investigator
Assaf-Harofeh MC, Bee'r Yaakov Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotics, Autologous Fecal Microbiota Transplantation and Cellules Pills in people with Physical Abilities and FMT, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilan Youngster, Dr. (+972-50630119, youngsteri@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome Profiling (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05024188, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.