Clinical Study on the Effect of Probiotic Compound Powder on the Immunity Improvement of Preschoo… (NCT05585021) | Clinical Trial Compass
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 range5 Years – 6 Years
SexALL
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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…
What they're measuring
1
Rotavirus diarrhea Testing at baseline
Timeframe: baseline(day 0)
2
Rotavirus diarrhea Testing at endpoint
Timeframe: endpoint( day 168)
3
Infection of the upper respiratory tract at baseline
Timeframe: baseline(day 0)
4
Infection of the upper respiratory tract at endpoint
Timeframe: endpoint ( day 168)
Trial details
NCT IDNCT05585021
SponsorShenzhen Precision Health Food Technology Co. Ltd.,