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

Fecal Microbiota Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04707222
• Other study ID #: 0277-19-ASF
• Status: Withdrawn
• Phase: N/A
• Start date: December 2021
• Est. completion date: September 2024

Study information

• Verified date: October 2021
• Source: Weizmann Institute of Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2024
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Fecal Microbiota Transplant
• Physical Abilities

Intervention

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

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Weizmann Institute of Science	Assaf-Harofeh Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiome composition	Stool, urine and oral samples will be sequenced and used for microbiota profiling	1 year
Primary	Glycemic response	Continuous glucose monitoring (CGM)	1 year
Primary	Muscle strength	"System 4 ™" BIODEX	1 year
Primary	Maximal aerobic capacity	VO2max test	1 year