NCT07310654

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

Effects of a 16-week Moderate-to-Vigorous Physical Activity Program on Physical Fitness and Gut Microbiota in Children: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 113 (estimated)
• Sponsor: Aiyoudong Children and Youth Sports Health Research Institute · Academic / Other
• Sex: All
• Age: 7 Years – 11 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a two-arm, parallel-group, randomized controlled trial with 1:1 allocation. Healthy children aged 7-10 years will be recruited. The intervention group will receive a 16-week structured MVPA program (3 sessions/week, 45-60 min/session). The control group will receive attention-matched sedentary activities (e.g., reading, crafts) and will be offered the MVPA program after the trial (waitlist). Blinding will be applied to outcome assessors and laboratory/bioinformatics analysts. The primary analysis will follow the intention-to-treat (ITT) principle. The study aims to determine if the MVPA intervention improves physical fitness and modulates the gut microbiota, and to explore baseline microbiota features as potential modifiers of the intervention response.

Conditions

• Healthy

Interventions

Type	Name	Description
BEHAVIORAL	16-week Structured MVPA Program	A 16-week structured moderate-to-vigorous physical activity program.
BEHAVIORAL	Attention Control Sedentary Activities	Time-matched sedentary activities such as reading, science experiments, or crafts.

Timeline

• Start date: 2025-12-20
• Primary completion: 2026-04-20
• Completion: 2026-06-30
• First posted: 2025-12-30
• Last updated: 2025-12-30

Locations

1 site across 1 country: China