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This is a randomized controlled trial, to evaluate the effect of WONDERLAB Probiotic Compound Powder on improving immunity of preschool children
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wonderlab Kids instant probiotics | Experimental | Wonderlab Kids instant probiotics (hawthorn flavor) (4 strains, 20 billion CFU/bottle) 2g/bottle |
|
| Instant probiotic placebo | Placebo Comparator | Instant probiotic placebo (ET) 2g/bottle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wonderlab Kids instant probiotics | Dietary Supplement | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoyang Sheng, MD | Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wenan Wang | Jinhua | Zhejiang | 321013 | China |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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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%.
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|
| Instant probiotic placebo | Dietary Supplement | 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. |
|
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) |