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

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

This is a randomized controlled trial, to evaluate the effect of WONDERLAB Probiotic Compound Powder on improving immunity of preschool children

Study Overview

• Status: Recruiting
• Conditions: Immunity
• Intervention / Treatment: Dietary supplement: Wonderlab Kids instant probiotics; Dietary supplement: Instant probiotic placebo

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 Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Jinhua, Zhejiang, China, 321013
      • Recruiting
      • Wenan Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wonderlab Kids instant probiotics; Wonderlab Kids instant probiotics (hawthorn flavor) (4 strains, 20 billion CFU/bottle) 2g/bottle	Dietary supplement: 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.
Placebo Comparator: Instant probiotic placebo; Instant probiotic placebo (ET) 2g/bottle	Dietary supplement: 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.

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)

Collaborators and Investigators

• Sponsor: Shenzhen Precision Health Food Technology Co. Ltd.,
• Investigators: Principal Investigator: Xiaoyang Sheng, MD, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): May 30, 2023

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Rotavirus; Upper respiratory tract infection; Bristol scoring method
• Other Study ID Numbers: 22-SM-08-WL-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No