Influence of Shenqu Xiaoshi Oral Liquid on Intestinal Microbiome of Children With Functional Dyspepsia

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation on the Influence of Shenqu Xiaoshi Oral Liquid for the Intestinal Microbiome of Children With Functional Dyspepsia

Conditions
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Dyspepsia, Child

Intervention / Treatment
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* Drug: Shenqu Xiaoshi Oral liquid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shenqu Xiaoshi Oral liquid<br>Shenqu Xiaoshi Oral liquid will be taken orally. | Drug: Shenqu Xiaoshi Oral liquid<br>* 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.<br>* Other names: SXOL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Treatment for 2-week | 
| Levels of hormones | e.g., Gastrin and Motilin | Treatment for 2-week | 
| Levels of inflammatory cytokines | e.g., TNF-α and IL-6 | 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. | Treatment for 1-week and 2-week |