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Completed
NCT07310654
Physical Activity and Gut Microbiota in Children (PA-Microbiome Kids)
Conditions: Healthy
Sex: All
Ages: 7 Years – 11 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 113
Sponsor: Aiyoudong Children and Youth Sports Health Research Institute
Location: Aiyoudong Children and Youth Sports Health Research Institute Weifang Shandong
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07310654). StuddyBuddy aggregates publicly available trial information.