Functional Constipation (FC)NCT07002489
Efficacy of Notrande Shuhuajun Probiotic Supplement on Lmproving Constipation in Preschool Children
A study testing Nuotelande Shuhuajun Study Product in people with Functional Constipation (FC), run by Shandong Sibote Biotechnology Co., Ltd. at 1 site in China.
Trial summary
The goal of this interventional study is to evaluate the effectiveness of Notrande Shuhuajun Probiotic Supplement intake on the improvement of functional constipation in preschool children (3-6 years old). Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Functional Constipation (FC)
- What is being tested?
- Nuotelande Shuhuajun Study Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2025to 24 Aug 2025
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants must be preschool children (aged 3-6);
- Participants were diagnosed with functional constipation based on Rome IV criteria;
- Participants agreed not to take any drugs, supplements, or other dairy products during the trial period;
- Participants agreed not to take any other prebiotic/bacterial drugs, supplements, or dairy products including yogurt beverages during the trial period;
- Be willing to refrain from participating in other interventional clinical studies during the trial period;
- Be able to fully understand the nature, purpose, benefits obtained, as well as possible risks and side effects of this study;
- Be willing to comply with all test requirements and procedures;
- Sign the informed consent form;
Who cannot join
- In the treatment of gastrointestinal symptoms;
- Lactose intolerance;
- Currently suffering from other organic diseases that affect intestinal function, such as a history of gastrointestinal resection, colon or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, congenital megacolon, scleroderma, anorexia nervosa, etc;
- Have been controlling diet, increasing exercise, or taking drugs to control weight or affect appetite in the last three months;
- Have any of the following medical histories or have been clinically diagnosed with any of the following diseases that may affect the evaluation of the trial effect: obvious gastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases;
- Current or past abuse of alcohol or other prohibited drugs, supplements or OTC prescription drugs may cause intestinal dysfunction or affect the evaluation of the test results;
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- According to the researchers' judgment, drugs that may affect gastrointestinal function or the immune system are currently being frequently used;
- Laxatives or other digestive AIDS were used two weeks before the start of the trial;
- Have consumed dairy products or other foods containing prebiotics/bacteria 10 days before the start of the trial;
- The research doctors believed that the volunteers could not fully cooperate with the trial arrangements;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-arm, Open-label Study of Efficacy of Notrande Shuhuajun Probiotic Supplement on Lmproving Constipation in Preschool Children Aged 3-6
The goal of this interventional study is to evaluate the effectiveness of Notrande Shuhuajun Probiotic Supplement intake on the improvement of functional constipation in preschool children (3-6 years old). The main questions it aims to answer are:
- Does Notrande Shuhuajun Probiotic Supplement intake improve functional constipation in preschool children?
Read more
105 eligible participants will be enrolled in one center and assigned the study product. After one week washout period participants need to take in the product for two weeks, followed by a one-week regression period.
Researchers will collect data, analyze data and conclude whether the study product is effective to improve constipation in participants, by comparing the change of concentration of biochemical indicators SCFA (Short-chain fatty acids), Lactobacillus and Bifidobacterium, and visual analysis of Bristol Stool scale etc..
- Conditions
- Functional Constipation (FC)
- Being tested
- Nuotelande Shuhuajun Study Product
- Keywords
- probiotics, constipation, functional constipation, pre-school children
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuotelande Shuhuajun Study ProductDietary supplement
Participants in this arm need to take in the assigned product - Notrande Shuhuajun Probiotic Supplement, 1 capsule per day, for 14 consecutive days. Don't take in similar products in the following 7 days (regression phase).
| Study group | Role | What they receive |
|---|---|---|
| Notrande Shuhuajun Probiotic Supplement Study Product | Other | Notrande Shuhuajun Probiotic Supplement, Each capsule contains the following active ingredients: ≥79.5 mg of the specially developed formula, 1 × 108 CFU of Lactobacillus fermentum CECT5716, 5 × 109 CFU of Lactobacillus rhamnosus GG, 5 × 109 CFU of Bifidobacterium animalis (Lactobacillus subspecies HNO19), and 1 × 108 CFU of Lactobacillus rhamnosus HNO01. Receives: Dietary Supplement: Nuotelande Shuhuajun Study Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of constipation indicators-SCFA (Short-chain fatty acids) level in the fecal samples
Change of constipation indicators: SCFA (Short-chain fatty acids) level in the fecal samples, from baseline day 0, to day 14, and to end day 21. unit: mg/100g fecal sample, higher level means improved constipation.
Measured: day 0, day 14, and day 21
Change of constipation indicators- Probiotics - Lactobacillus and Bifidobacterium concentration level in the fecal samples
Change of constipation indicators: Probiotics - Lactobacillus and Bifidobacterium concentration level via qPCR in the fecal samples, from baseline day 0, to day 14, and to end day 21. unit: CFU/g, higher level means improved constipation.
Measured: day 0, day 14, and day 21
Secondary outcomes (1)
Change of Bristol Stool Form Scale (BSFS)
Change of Bristol Stool Form Scale (BSFS) by visual judgement of look and form of participants' bowel movements, type 1 to type 7, mapping to score 1 to 7, the smaller value indicates improved constipation.
Measured: day 0 , day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start30 May 2025
- Primary completion24 Aug 2025
- Study completion24 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Constipation (FC)Studies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Sibote Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charlie Zhang, MD, Principal investigator, Raison Biotech Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002489
- Sponsor's protocol ID
- 25-RD-04-JJ-001
- Status last verified
- Dec 2025
- First submitted
- 25 May 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The abstract of final clinical study report will be shared via official website.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Study of Efficacy of Notrande Shuhuajun Probiotic Supplement on Lmproving Constipation in Preschool Children Aged 3-6
- ClinicalTrials.gov ID
- NCT07002489
- Acronym / sponsor ID
- 25-RD-04-JJ-001
- Conditions
- Functional Constipation (FC)
- Keywords
- probiotics, constipation, functional constipation, pre-school children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Shandong Sibote Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 May 2025 (actual)
- Primary completion
- 24 Aug 2025 (actual)
- Study completion
- 24 Aug 2025 (actual)
- First posted
- 3 Jun 2025 (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.
The goal of this interventional study is to evaluate the effectiveness of Notrande Shuhuajun Probiotic Supplement intake on the improvement of functional constipation in preschool children (3-6 years old). The main questions it aims to answer are:
- Does Notrande Shuhuajun Probiotic Supplement intake improve functional constipation in preschool children?
105 eligible participants will be enrolled in one center and assigned the study product. After one week washout period participants need to take in the product for two weeks, followed by a one-week regression period.
Researchers will collect data, analyze data and conclude whether the study product is effective to improve constipation in participants, by comparing the change of concentration of biochemical indicators SCFA (Short-chain fatty acids), Lactobacillus and Bifidobacterium, and visual analysis of Bristol Stool scale etc..
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Notrande Shuhuajun Probiotic Supplement Study Product | Other | Dietary Supplement: Nuotelande Shuhuajun Study ProductNotrande Shuhuajun Probiotic Supplement, Each capsule contains the following active ingredients: ≥79.5 mg of the specially developed formula, 1 × 108 CFU of Lactobacillus fermentum CECT5716, 5 × 109 CFU of Lactobacillus rhamnosus GG, 5 × 109 CFU of Bifidobacterium animalis (Lactobacillus subspecies HNO19), and 1 × 108 CFU of Lactobacillus rhamnosus HNO01. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Participants must be preschool children (aged 3-6);
- Participants were diagnosed with functional constipation based on Rome IV criteria;
- Participants agreed not to take any drugs, supplements, or other dairy products during the trial period;
- Participants agreed not to take any other prebiotic/bacterial drugs, supplements, or dairy products including yogurt beverages during the trial period;
- Be willing to refrain from participating in other interventional clinical studies during the trial period;
Key exclusion criteria (10 listed)
- In the treatment of gastrointestinal symptoms;
- Lactose intolerance;
- Currently suffering from other organic diseases that affect intestinal function, such as a history of gastrointestinal resection, colon or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, congenital megacolon, scleroderma, anorexia nervosa, etc;
- Have been controlling diet, increasing exercise, or taking drugs to control weight or affect appetite in the last three months;
- Have any of the following medical histories or have been clinically diagnosed with any of the following diseases that may affect the evaluation of the trial effect: obvious gastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases;
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 |
|---|---|---|
| Nuotelande Shuhuajun Study ProductParticipants in this arm need to take in the assigned product - Notrande Shuhuajun Probiotic Supplement, 1 capsule per day, for 14 consecutive days. Don't take in similar products in the following 7 days (regression phase). | Dietary supplement | Notrande Shuhuajun Probiotic Supplement Study Product |
Primary outcome
Change of constipation indicators-SCFA (Short-chain fatty acids) level in the fecal samples
Time frame: day 0, day 14, and day 21
Change of constipation indicators: SCFA (Short-chain fatty acids) level in the fecal samples, from baseline day 0, to day 14, and to end day 21. unit: mg/100g fecal sample, higher level means improved constipation.
Change of constipation indicators- Probiotics - Lactobacillus and Bifidobacterium concentration level in the fecal samples
Time frame: day 0, day 14, and day 21
Change of constipation indicators: Probiotics - Lactobacillus and Bifidobacterium concentration level via qPCR in the fecal samples, from baseline day 0, to day 14, and to end day 21. unit: CFU/g, higher level means improved constipation.
1 secondary outcome
Change of Bristol Stool Form Scale (BSFS)
Time frame: day 0 , day 21
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 19 Dec 2025.
- Individual participant dataSharing planned: Yes. The abstract of final clinical study report will be shared via official website.
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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.
Charlie Zhang, MD principal investigator
Raison Biotech Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nuotelande Shuhuajun Study Product in people with Functional Constipation (FC), run by Shandong Sibote Biotechnology 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 8 inclusion and 10 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 19 Dec 2025. 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. 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?
Change of constipation indicators-SCFA (Short-chain fatty acids) level in the fecal samples (time frame: day 0, day 14, and day 21). The study lists 2 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 19 Dec 2025.