ImmunityNCT05585021
Clinical Study on the Effect of Probiotic Compound Powder on the Immunity Improvement of Preschool Children
A study testing Wonderlab Kids instant probiotics in people with Immunity, run by Shenzhen Precision Health Food Technology Co. Ltd., at 1 site in China.
Trial summary
This is a randomized controlled trial, to evaluate the effect of WONDERLAB Probiotic Compound Powder on improving immunity of preschool children Read more about this study
- Who is it for?
- Ages 5 to 6 years
- Conditions the study is for
- Immunity
- What is being tested?
- Wonderlab Kids instant probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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%.
- Conditions
- Immunity
- Being tested
- Wonderlab Kids instant probiotics, Instant probiotic placebo
- Keywords
- Rotavirus, Upper respiratory tract infection, Bristol scoring method
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wonderlab Kids instant probioticsDietary 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.
Instant probiotic placeboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Wonderlab Kids instant probiotics | Experimental | Wonderlab Kids instant probiotics (hawthorn flavor) (4 strains, 20 billion CFU/bottle) 2g/bottle Receives: Dietary Supplement: Wonderlab Kids instant probiotics |
| Instant probiotic placebo | Placebo comparator | Instant probiotic placebo (ET) 2g/bottle Receives: Dietary Supplement: Instant probiotic placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotavirus diarrhea Testing at baseline
Records of sick leave days, medical visits and hospitalization days due to rotavirus infection within past 12 month
Measured: 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
Measured: endpoint( day 168)
Infection of the upper respiratory tract at baseline
Drug records of upper respiratory tract infection within past 12 months.
Measured: baseline(day 0)
Infection of the upper respiratory tract at endpoint
Drug records of upper respiratory tract infection within past 168 days.
Measured: endpoint ( day 168)
Secondary outcomes (4)
Bristol Stool Chart
To evaluate samples of human feces based on the shape and consistency of the stool.
Measured: baseline(day 0)/interim ( day 84)/endpoint( day 168)/recession period( day 175)
Faeces
sIgA 、16sRNA、SCFA、Fecal calprotectin
Measured: baseline(day 0)/interim ( day 84)/endpoint( day 168)/recession period( day 175)
Saliva
sIgA testing
Measured: 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.
Measured: baseline(day 0)/interim ( day 84)/endpoint( day 168)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start19 Oct 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Precision Health Food Technology Co. Ltd.,
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Xiaoyang Sheng, MD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585021
- Sponsor's protocol ID
- 22-SM-08-WL-001
- Status last verified
- Nov 2023
- First submitted
- 12 Oct 2022
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on The Effect of Probiotic Compound Powder (WONDERLAB) on The Immunity Improvement of Preschool Children (RCT)
- ClinicalTrials.gov ID
- NCT05585021
- Acronym / sponsor ID
- 22-SM-08-WL-001
- Conditions
- Immunity
- Keywords
- Rotavirus, Upper respiratory tract infection, Bristol scoring method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Shenzhen Precision Health Food Technology Co. Ltd.,Other government
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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%.
| Arm | Type | Receives |
|---|---|---|
| Wonderlab Kids instant probiotics | Experimental | Dietary Supplement: Wonderlab Kids instant probioticsWonderlab Kids instant probiotics (hawthorn flavor) (4 strains, 20 billion CFU/bottle) 2g/bottle |
| Instant probiotic placebo | Placebo comparator | Dietary Supplement: Instant probiotic placeboInstant probiotic placebo (ET) 2g/bottle |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Preschool children, male or female, 5 to 6 years old;
- Those with weak constitution and easy to get sick:
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wonderlab Kids instant probioticsDuring 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. | Dietary supplement | Wonderlab Kids instant probiotics |
| Instant probiotic placeboSubjects 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. | Dietary supplement | Instant probiotic placebo |
Primary outcome
Rotavirus diarrhea Testing at baseline
Time frame: 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
Time frame: 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 baseline
Time frame: baseline(day 0)
Drug records of upper respiratory tract infection within past 12 months.
Infection of the upper respiratory tract at endpoint
Time frame: endpoint ( day 168)
Drug records of upper respiratory tract infection within past 168 days.
4 secondary outcomes
Bristol Stool Chart
Time frame: baseline(day 0)/interim ( day 84)/endpoint( day 168)/recession period( day 175)
Faeces
Time frame: baseline(day 0)/interim ( day 84)/endpoint( day 168)/recession period( day 175)
Saliva
Time frame: baseline(day 0)/interim ( day 84)/endpoint( day 168)/recession period( day 175)
Pittsburgh sleep quality index
Time frame: baseline(day 0)/interim ( day 84)/endpoint( day 168)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoyang Sheng, MD principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wonderlab Kids instant probiotics in people with Immunity, run by Shenzhen Precision Health Food Technology Co. Ltd., at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rotavirus diarrhea Testing at baseline (time frame: baseline(day 0)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.