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

Study Overview
=================
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%.

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

Conditions
-----------------
Immunity

Intervention / Treatment
-----------------
* Dietary Supplement: Wonderlab Kids instant probiotics
* Dietary Supplement: Instant probiotic placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model 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%.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wonderlab Kids instant probiotics<br>Wonderlab Kids instant probiotics (hawthorn flavor) (4 strains, 20 billion CFU/bottle) 2g/bottle | Dietary Supplement: Wonderlab Kids instant probiotics<br>* 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.<br>|
| Placebo Comparator: Instant probiotic placebo<br>Instant probiotic placebo (ET) 2g/bottle | Dietary Supplement: Instant probiotic placebo<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bristol Stool Chart | To evaluate samples of human feces based on the shape and consistency of the stool. | baseline(day 0)/interim ( day 84)/endpoint( day 168)/recession period( day 175) | 
| Faeces | sIgA 、16sRNA、SCFA、Fecal calprotectin | baseline(day 0)/interim ( day 84)/endpoint( day 168)/recession period( day 175) | 
| Saliva | sIgA testing | baseline(day 0)/interim ( day 84)/endpoint( day 168)/recession period( day 175) | 
| Pittsburgh sleep quality index | 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. | baseline(day 0)/interim ( day 84)/endpoint( day 168) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rotavirus, Upper respiratory tract infection, Bristol scoring method