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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-55
SponsorAssaf-Harofeh Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Antibiotics

    Drug

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

  • Autologous Fecal Microbiota Transplantation

    Other intervention

    Autologous Fecal Microbiota Transplantation( aFMT( stool taken from the participant, prior to antibiotic treatment)

  • Cellules Pills

    Other intervention

    7 days of cellules placebo pills.

  • placebo capsules

    Other intervention

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

Treatment groups

70 Participants
are divided into 3 treatment groups
Group A: Antibiotics + FMTExperimental treatment 3 interventions
Group B: PlaceboPlacebo comparator 2 interventions
Group C: Antibiotics+placeboExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Microbiome Profiling

Using stool and buccal samples for microbiome composition analysis

Time frame
1 month
2

Physical ability

will be measured by several tests: flexibility, Biodex, maximal oxygen uptake (VO2 max), high jumps, 30 seconds jumps, lactate measurement.

Time frame
1 month

Secondary outcomes

1

Glycemic Responses

Performing continuous glucose monitor (CGM)

Time frame
1 month

Other outcomes

1

D- lactate measurement

measuring D-Lactate threshold

Time frame
18 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assaf-Harofeh Medical Center

Lead sponsor

Weizmann Institute of Science

Collaborator

Wingate Institute

Collaborator