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

NCT05585021 | Completed DMC

• 1 other identifier: 22-SM-08-WL-001
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Immunity

Keywords

Rotavirus; Upper respiratory tract infection; Bristol scoring method

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Bristol Stool Chart

  baseline(day 0)/interim ( day 84)/endpoint( day 168)/recession period( day 175)

• Faeces

  baseline(day 0)/interim ( day 84)/endpoint( day 168)/recession period( day 175)

• Saliva

  baseline(day 0)/interim ( day 84)/endpoint( day 168)/recession period( day 175)

• Pittsburgh sleep quality index

  baseline(day 0)/interim ( day 84)/endpoint( day 168)

Study Arms (2)

Wonderlab Kids instant probiotics

EXPERIMENTAL

Wonderlab Kids instant probiotics (hawthorn flavor) (4 strains, 20 billion CFU/bottle) 2g/bottle

Dietary Supplement: Wonderlab Kids instant probiotics

Instant probiotic placebo

PLACEBO COMPARATOR

Instant probiotic placebo (ET) 2g/bottle

Dietary Supplement: Instant probiotic placebo

Interventions

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.

Wonderlab Kids instant probiotics

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.

Instant probiotic placebo

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Precision Health Food Technology Co. Ltd.,: lead

Study Sites (1)

Wenan Wang

Jinhua, Zhejiang, 321013, China

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Xiaoyang Sheng, MD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: October 12, 2022
• First Posted: October 18, 2022
• Study Start: October 19, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

CN (1)