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The Role of the Gut Microbiome in Modulating Physical Abilities in Humans

Sponsor
Weizmann Institute of Science (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04707222
Collaborator
Assaf-Harofeh Medical Center (Other)
0
Enrollment
2
Arms
33
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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. The diversity of athletes' gut microbiome was found higher compared to gender and age-matched controls. However, important mechanistic questions related to the possible associations between exercise and the human gut microbiome remain unanswered.

In this study, we propose to investigate 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ciprofloxacin & Metronidazole
  • Other: Placebo
  • Other: Fecal microbiome transplant
 N/A

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, they will consume the pills for 7 days.

In the third segment, participants will undergo a Fecal Microbiota Transplant/placebo administration. Subjects will be NPO at least 4 h before and for 1 hour following capsule intake, to minimize the risk of vomiting during ingestion of capsules. In the event of vomiting, patients will not be re-dosed. All patients will be evaluated after taking capsules by the study investigators and observed for 15 minutes. Phone follow up and assessment using open-ended questions and a standardized adverse event grading scale will take place 24-48hrs after the administration.

Throughout the study, participants will collect stool and buccal samples which will be used for microbiota profiling.

In study meetings, anthropometric measurements, medical history, GI symptoms questioner, blood samples, urine samples, and Dual X-ray absorptiometry (DXA) will be taken. Participants will also perform an extensive set of physical abilities test.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Assessing the Potential Role of the Gut Microbiome in Modulating Physical Abilities in Humans
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Antibiotics+FMT

7 days of antibiotics- Ciprofloxacin, 500 mg 2/day & Metronidazole (Flagyl), 500 mg 3/day. Fecal Microbiota Transplant

Drug: Ciprofloxacin & Metronidazole
Ciprofloxacin, 500 mg 2/day & Metronidazole (Flagyl), 500 mg 3/day
Other Names:
  • antibiotics

    • Other: Fecal microbiome transplant
    Fecal bacteriotherapy is the process of transferring stool from a healthy donor to another.
    Placebo Comparator: Placebo

    7 days of cellulose placebo pills.

    Other: Placebo
    Placebo pills

    Outcome Measures

    Primary Outcome Measures

    1. Microbiome composition [1 year]

      Stool, urine and oral samples will be sequenced and used for microbiota profiling

    2. Glycemic response [1 year]

      Continuous glucose monitoring (CGM)

    3. Muscle strength [1 year]

      "System 4 ™" BIODEX

    4. Maximal aerobic capacity [1 year]

      VO2max test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • BMI<28

    • Age - 20-35

    • Use to exercise in one or more of the following sports areas: running, swimming, Zumba, dance or Aerobe class, football, basketball, functional training, volleyball, surfing, tennis, wrestling athletics.

    • Exercise at least twice a week, for a minimum duration of 6 months.

    Exclusion Criteria:

    • Consumption of antibiotics or probiotics 3 months prior to the first day of the experiment.

    • Diagnosis of type 1 or type 2 diabetes.

    • Pregnancy, fertility treatments

    • Chronic disease (e.g. AIDS, Cushing syndrome, CKD, acromegaly, hyperthyroidism etc.)

    • Cancer and recent anticancer treatment

    • Psychiatric disorders

    • Coagulation disorders

    • IBD (inflammatory bowel diseases)

    • Bariatric surgery

    • Alcohol or substance abuse

    • BMI>28

    • Any physical condition precluding the completion of a routine effort test

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Weizmann Institute of Science
    • Assaf-Harofeh Medical Center

    Investigators

    • Principal Investigator: Eran Elinav, Prof, Weizmann Institute of Science

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eran Elinav, Principal Investigator, Host-Microbiome Interaction Research Group, Weizmann Institute of Science
    ClinicalTrials.gov Identifier:
    NCT04707222
    Other Study ID Numbers:
    • 0277-19-ASF
    First Posted:
    Jan 13, 2021
    Last Update Posted:
    Nov 5, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Anti-Bacterial Agents
    Metronidazole
    Ciprofloxacin

    Study Results

    No Results Posted as of Nov 5, 2021