CompletedNot Applicable

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

China140 participantsStarted 2022-10-19

Plain-language summary

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

Who can participate

Age range

5 Years – 6 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: * Preschool children, male or female, 5 to 6 years old; * Those with weak constitution and easy to get sick: One of them can be satisfied: AGet cold ≥ 3 times a year B Bronchitis or pneumonia ≥2 times per year C Rotavirus diarrhea ≥1 time per year * During the trial, participants agree not to take any drugs, supplements, or other dairy products containing probiotics; * During the trial, participants agree not to take any other prebiotic/bacterial drugs, supplements, or dairy products including yogurt drinks; * Willing to refrain from participating in other interventional clinical studies during the trial period; * Be able to fully understand the nature, purpose, benefits and possible risks and side effects of the research; * Willing to obey all test requirements and procedures; * Informed consent signed by parents or legal guardians. Exclusion Criteria: * Subject who is in the treatment of gastrointestinal diseases; * Subject who has lactose intolerance; * The subjects are currently suffering from other organic diseases that affect intestinal function, such as history of gastrointestinal resection, colonic or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, Hirschsprung's disease, scleroderma, anorexia nervosa, etc.; * Subjects have any of the following medical histories or clinically diagnosed diseases that may affect the evaluation of the test effect: obvious gastrointestinal dysfunction, liver, kidney, endocr…

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

Rotavirus diarrhea Testing at baseline

Timeframe: baseline(day 0)

Rotavirus diarrhea Testing at endpoint

Timeframe: endpoint( day 168)

Infection of the upper respiratory tract at baseline

Timeframe: baseline(day 0)

Infection of the upper respiratory tract at endpoint

Timeframe: endpoint ( day 168)

Trial details

NCT IDNCT05585021

SponsorShenzhen Precision Health Food Technology Co. Ltd.,

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-04-30

View on ClinicalTrials.gov More Immunity trials

Who can participate

Age range

5 Years – 6 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.