CompletedNot Applicable

Physical Activity and Gut Microbiota in Children (PA-Microbiome Kids)

China113 participantsStarted 2025-12-31

Plain-language summary

This study evaluates the effect of a 16-week moderate-to-vigorous physical activity (MVPA) program on physical fitness and gut microbiota in healthy school-aged children. Participants will be randomly assigned to either an MVPA intervention group or an attention-control group. The primary outcome is the change in a composite physical fitness score. Secondary outcomes include changes in gut microbiota diversity and composition.

Who can participate

Age range

7 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants from a previous cross-sectional study cohort conducted in 2023 (Pan et al., Sci Rep 2025;15:21351), at which time they were 6-9 years old. * Able to complete the 16-week follow-up. * Guardian provides written informed consent, and the child provides assent. * Medically cleared by a physician or school nurse to participate in moderate-intensity physical activity (no contraindications). * No antibiotic use in the 4 weeks prior to baseline. * No fever or acute gastroenteritis in the 2 weeks prior to baseline. * Able to provide stool samples as required. Exclusion Criteria: * Diagnosed with cardiopulmonary diseases, epilepsy, severe asthma, severe musculoskeletal disorders, or congenital heart disease. * Recent acute exacerbation of chronic gastrointestinal diseases. * Planning to follow a special diet (e.g., ketogenic, vegetarian) or requiring long-term prescription of antibiotics/probiotics. * Planning to be absent for \>20% of the intervention period due to travel or other commitments. * Enrolled in other high-intensity sports training programs that cannot be cancelled. * Developmental or behavioral issues that would impede cooperation, as assessed by teachers and parents.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Composite Physical Fitness Z-score

Timeframe: Baseline and 16 weeks

Trial details

NCT IDNCT07310654

SponsorAiyoudong Children and Youth Sports Health Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-22

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