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

Not Applicable

Completed

• Conditions: Immunity
• Interventions: Dietary Supplement: Instant probiotic placebo; Dietary Supplement: Wonderlab Kids instant probiotics

• Registration Number: NCT05585021
• Lead Sponsor: Shenzhen Precision Health Food Technology Co. Ltd.,

Brief 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%.

Study Timeline

• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-14
• Study First Posted: 2022-10-18
• Study Start: 2022-10-19
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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, 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Instant probiotic placebo	Instant probiotic placebo	Instant probiotic placebo (ET) 2g/bottle
Wonderlab Kids instant probiotics	Wonderlab Kids instant probiotics	Wonderlab Kids instant probiotics (hawthorn flavor) (4 strains, 20 billion CFU/bottle) 2g/bottle

Primary Outcome Measures

Name	Time	Method
Infection of the upper respiratory tract at baseline	baseline(day 0)	Drug records of upper respiratory tract infection within past 12 months.
Rotavirus diarrhea Testing at baseline	baseline(day 0)	Records of sick leave days, medical visits and hospitalization days due to rotavirus infection within past 12 month
Rotavirus diarrhea Testing at endpoint	endpoint( day 168)	Records of sick leave days, medical visits and hospitalization days due to rotavirus infection within past 168 days
Infection of the upper respiratory tract at endpoint	endpoint ( day 168)	Drug records of upper respiratory tract infection within past 168 days.

Secondary Outcome Measures

Name	Time	Method
Saliva	baseline(day 0)/interim ( day 84)/endpoint( day 168)/recession period( day 175)	sIgA testing
Bristol Stool Chart	baseline(day 0)/interim ( day 84)/endpoint( day 168)/recession period( day 175)	To evaluate samples of human feces based on the shape and consistency of the stool.
Faeces	baseline(day 0)/interim ( day 84)/endpoint( day 168)/recession period( day 175)	sIgA 、16sRNA、SCFA、Fecal calprotectin
Pittsburgh sleep quality index	baseline(day 0)/interim ( day 84)/endpoint( day 168)	18 items comprise 7 components, each of which is scored according to o\~3 grade. The cumulative score of each component is the total score of PSQI, with a total score range of 0\~2l. The higher the score, the worse the sleep quality.

Trial Locations

Locations (1)

Wenan Wang; 🇨🇳 Jinhua, Zhejiang, China