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

FMT Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05024188
• Other study ID #: 0277-19-ASF
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: January 20, 2023

Study information

• Verified date: December 2021
• Source: Assaf-Harofeh Medical Center
• Contact: Ilan Youngster, Dr.
• Phone: +972-50630119
• Email: youngsteri[@]asaf.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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, 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 20, 2023
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• FMT
• Physical Abilities

Intervention

Drug:
• Antibiotics
Ciprofloxacin, 500 mg 2/day & Metronidazole (Flagyl), 500 mg 3/day.

Other:
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assaf Harofeh MC	Weizmann Institute of Science

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiome Profiling	Collection of stool and buccal samples samples for microbiome composition analysis with16s rRNA sequencing.	2 years
Primary	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
Primary	Body Circumferences	waist, hips, and limbs (cm).	2 years
Secondary	Glycemic Responses	Performing continuous glucose monitor (CGM)	2 years
Secondary	Bone Mineral Density (BMD)	Using Dual X-ray absorptiometry (DXA) test	2 years