Clinical Study on the Effect of Probiotic Compound Powder on the Immunity Improvement of Preschool Children
NCT ID: NCT05585021
Last Updated: 2023-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2022-10-19
2023-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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%.
OTHER
SINGLE
Study Groups
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Wonderlab Kids instant probiotics
Wonderlab Kids instant probiotics (hawthorn flavor) (4 strains, 20 billion CFU/bottle) 2g/bottle
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.
Instant probiotic placebo
Instant probiotic placebo (ET) 2g/bottle
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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, endocrine, blood, respiratory and cardiovascular diseases;
* According to the judgment of the researchers, frequent use of drugs that may affect gastrointestinal function or the immune system;
* Subjects who took laxatives or other digestive aids 2 weeks before the start of the study;
* Consumed dairy products or other foods containing prebiotics/bacteria within 10 days before the start of the study;
* PI believes that volunteers cannot fully cooperate with the trial arrangement.
5 Years
6 Years
ALL
No
Sponsors
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Shenzhen Precision Health Food Technology Co. Ltd.,
OTHER_GOV
Responsible Party
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Principal Investigators
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Xiaoyang Sheng, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiao Tong University School of Medicine
Locations
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Wenan Wang
Jinhua, Zhejiang, China
Countries
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Other Identifiers
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22-SM-08-WL-001
Identifier Type: -
Identifier Source: org_study_id