NCT05585021

Clinical Study on the Effect of Probiotic Compound Powder on the Immunity Improvement of Preschool Children

A Clinical Study on The Effect of Probiotic Compound Powder (WONDERLAB) on The Immunity Improvement of Preschool Children (RCT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Shenzhen Precision Health Food Technology Co. Ltd., · Other Government
• Sex: All
• Age: 5 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled trial, to evaluate the effect of WONDERLAB Probiotic Compound Powder on improving immunity of preschool children

Detailed description

The community hospital will recruit 140 preschool children, aged 5 to 6 years old, according to the inclusion and exclusion criteria, and randomly assigned them to 2 groups. 70 subjects in the placebo group and 70 in the experimental product group. First entered a one-week washout period, and then entered a 25-week clinical intervention, and finally ensured that 100 volunteers completed the whole study, and the withdrawal rate was about 28%.

Conditions

• Immunity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Wonderlab Kids instant probiotics	During study intervention, subjects are required to take the randomly assigned product based on the randomization list. Taking assigned product directly or mix it with milk/water/other liquids below 37 ℃, take it half an hour after meal.1 bottle a day. Lasting for 24 weeks intervention period.
DIETARY_SUPPLEMENT	Instant probiotic placebo	Subjects are required to take the randomly assigned Instant probiotic placebo based on the randomization list. Taking assigned product directly or mix it with milk/water/other liquids below 37 ℃, half an hour after meal. 1 bottle a day. Lasting for 24 weeks intervention period.

Timeline

• Start date: 2022-10-19
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2022-10-18
• Last updated: 2023-11-24

Locations

1 site across 1 country: China