DyspepsiaPhase 4NCT05515887
Influence of Shenqu Xiaoshi Oral Liquid on Intestinal Microbiome of Children With Functional Dyspepsia
A Phase 4 study testing Shenqu Xiaoshi Oral liquid in people with Dyspepsia and Child, run by Ruijin Hospital at 1 site in China.
Trial summary
It has been confirmed that treatment with Shenqu Xiaoshi Oral liquid (SXOL) effectively improves dyspeptic symptoms and is well tolerated. It is not inferior to domperidone syrup and leads to sustained improvement in Chinese children with functional dyspepsia (FD). Read more about this study
- Who is it for?
- Ages 3 to 14 years
- What is being tested?
- Shenqu Xiaoshi Oral liquid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2022to 31 Mar 2025
- Phase
- Phase 4
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Outpatients aged 3-14 years old;
- Meeting ≥1 condition(s): (1)Postprandial fullness;(2)early satiation;(3)Epigastric pain or burning not associated with defecation;
- Having symptoms at least 2 months and at least 4 days per month before diagnosis;
- During the 2-wk lead-in period, no relevant drugs for the treatment of dyspepsia and anorexia were used, good eating habits have been established, and the FD symptoms still existed (symptom score≥3).
- Informed consent was obtained from the parents/guardians of the participant. If the child was more than 8 years old, additional informed consent would be required from the participant.
Who cannot join
- Anorexia and dyspepsia caused by certain drugs and confirmed organic diseases such as erosive gastritis, peptic ulcer, etc;
- Severe malnutrition;
- Serious primary diseases of the cardiovascular, nervous, respiratory, hepatobiliary and endocrine systems;
- Mental disorders, intellectual disabilities, and/or communication impairments;
- Lactose intolerant or allergic to the ingredients of Shenqu Xiaoshi Oral Liquid or Traditional Chinese medicine;
- Probiotics or antibiotics within 4-wk;
- Participated in a clinical trial within the past 12-wk;
- Individuals deemed unsuitable for this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 021
About this study
Official title: Evaluation on the Influence of Shenqu Xiaoshi Oral Liquid for the Intestinal Microbiome of Children With Functional Dyspepsia
It has been confirmed that treatment with Shenqu Xiaoshi Oral liquid (SXOL) effectively improves dyspeptic symptoms and is well tolerated. It is not inferior to domperidone syrup and leads to sustained improvement in Chinese children with functional dyspepsia (FD). This study aims to evaluate the possible regulatory effect of SXOL on intestinal microbiome in children with FD, further exploring its related mechanism.
- Being tested
- Shenqu Xiaoshi Oral liquid
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shenqu Xiaoshi Oral liquidDrug
Also called SXOL
The dosage was determined by age: 3-4 years old, 5 ml/dose; 5-14 years old 10 ml/dose. Taken half an hour after meals, three times a day.
| Study group | Role | What they receive |
|---|---|---|
| Shenqu Xiaoshi Oral liquid | Experimental | Shenqu Xiaoshi Oral liquid will be taken orally. Receives: Drug: Shenqu Xiaoshi Oral liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal microbiome characteristics
All subjects faeces will be collected and analyzed by high-throughput metagenomic sequencing to find the characteristics (e.g., the α and β diversity, the abundance of changed species) and composition of intestinal microbiome.
Measured: Treatment for 2-week
Intestinal microbiome metabolites
Microbiome metabolites (e.g., short-chain fatty acid and bile acid) will be detected and analyzed by liquid chromatography-mass spectrometry (LC-MC) non-targeted metabolomics.
Measured: Treatment for 2-week
Levels of hormones
e.g., Gastrin and Motilin
Measured: Treatment for 2-week
Levels of inflammatory cytokines
e.g., TNF-α and IL-6
Measured: Treatment for 2-week
Clinical symptoms evaluation
Measured by a scale filling by subjects or their parents. The scale contains clinical symptoms of functional dyspepsia, such as postprandial fullness and early satiation. Scores range from 0 to 3 and higher scores represent more severe or more frequent.
Measured: Treatment for 1-week and 2-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start22 Nov 2022
- Primary completion31 Dec 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chundi Xu, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515887
- Sponsor's protocol ID
- SQXS20220325
- Status last verified
- Mar 2025
- First submitted
- 10 Aug 2022
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation on the Influence of Shenqu Xiaoshi Oral Liquid for the Intestinal Microbiome of Children With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT05515887
- Acronym / sponsor ID
- SQXS20220325
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 25 Aug 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.
It has been confirmed that treatment with Shenqu Xiaoshi Oral liquid (SXOL) effectively improves dyspeptic symptoms and is well tolerated. It is not inferior to domperidone syrup and leads to sustained improvement in Chinese children with functional dyspepsia (FD). This study aims to evaluate the possible regulatory effect of SXOL on intestinal microbiome in children with FD, further exploring its related mechanism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shenqu Xiaoshi Oral liquid | Experimental | Drug: Shenqu Xiaoshi Oral liquidShenqu Xiaoshi Oral liquid will be taken orally. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Outpatients aged 3-14 years old;
- Meeting ≥1 condition(s): (1)Postprandial fullness;(2)early satiation;(3)Epigastric pain or burning not associated with defecation;
- Having symptoms at least 2 months and at least 4 days per month before diagnosis;
- During the 2-wk lead-in period, no relevant drugs for the treatment of dyspepsia and anorexia were used, good eating habits have been established, and the FD symptoms still existed (symptom score≥3).
- Informed consent was obtained from the parents/guardians of the participant. If the child was more than 8 years old, additional informed consent would be required from the participant.
Key exclusion criteria (8 listed)
- Anorexia and dyspepsia caused by certain drugs and confirmed organic diseases such as erosive gastritis, peptic ulcer, etc;
- Severe malnutrition;
- Serious primary diseases of the cardiovascular, nervous, respiratory, hepatobiliary and endocrine systems;
- Mental disorders, intellectual disabilities, and/or communication impairments;
- Lactose intolerant or allergic to the ingredients of Shenqu Xiaoshi Oral Liquid or Traditional Chinese medicine;
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 |
|---|---|---|
| Shenqu Xiaoshi Oral liquidAlso: SXOLThe dosage was determined by age: 3-4 years old, 5 ml/dose; 5-14 years old 10 ml/dose. Taken half an hour after meals, three times a day. | Drug | Shenqu Xiaoshi Oral liquid |
Primary outcome
Intestinal microbiome characteristics
Time frame: Treatment for 2-week
All subjects faeces will be collected and analyzed by high-throughput metagenomic sequencing to find the characteristics (e.g., the α and β diversity, the abundance of changed species) and composition of intestinal microbiome.
Intestinal microbiome metabolites
Time frame: Treatment for 2-week
Microbiome metabolites (e.g., short-chain fatty acid and bile acid) will be detected and analyzed by liquid chromatography-mass spectrometry (LC-MC) non-targeted metabolomics.
Levels of hormones
Time frame: Treatment for 2-week
e.g., Gastrin and Motilin
Levels of inflammatory cytokines
Time frame: Treatment for 2-week
e.g., TNF-α and IL-6
Clinical symptoms evaluation
Time frame: Treatment for 1-week and 2-week
Measured by a scale filling by subjects or their parents. The scale contains clinical symptoms of functional dyspepsia, such as postprandial fullness and early satiation. Scores range from 0 to 3 and higher scores represent more severe or more frequent.
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 4 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Dyspepsia
Active, not recruitingPhase 1
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Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Functional Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Functional Dyspepsia, Probiotics
RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
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.
Chundi Xu principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shenqu Xiaoshi Oral liquid in people with Dyspepsia and Child, run by Ruijin Hospital 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 5 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 4 Apr 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Intestinal microbiome characteristics (time frame: Treatment for 2-week). The study lists 5 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 4 Apr 2025.