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

Phase 4

Completed

• Conditions: Dyspepsia; Child
• Interventions: Drug: Shenqu Xiaoshi Oral liquid

• Registration Number: NCT05515887
• Lead Sponsor: Ruijin Hospital

Brief 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). This study aims to evaluate the possible regulatory effect of SXOL on intestinal microbiome in children with FD, further exploring its related mechanism.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-25
• Study Start: 2022-11-22
• Primary Completion: 2024-12-31
• Status Verified: 2025-03
• Study Completion: 2025-03-31
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Outpatients aged 3-14 years old;
2. Meeting ≥1 condition(s): (1)Postprandial fullness;(2)early satiation;(3)Epigastric pain or burning not associated with defecation;
3. Having symptoms at least 2 months and at least 4 days per month before diagnosis;
4. 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).
5. 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

1. Anorexia and dyspepsia caused by certain drugs and confirmed organic diseases such as erosive gastritis, peptic ulcer, etc;
2. Severe malnutrition;
3. Serious primary diseases of the cardiovascular, nervous, respiratory, hepatobiliary and endocrine systems;
4. Mental disorders, intellectual disabilities, and/or communication impairments;
5. Lactose intolerant or allergic to the ingredients of Shenqu Xiaoshi Oral Liquid or Traditional Chinese medicine;
6. Probiotics or antibiotics within 4-wk;
7. Participated in a clinical trial within the past 12-wk;
8. Individuals deemed unsuitable for this clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Shenqu Xiaoshi Oral liquid	Shenqu Xiaoshi Oral liquid	Shenqu Xiaoshi Oral liquid will be taken orally.

Primary Outcome Measures

Name	Time	Method
Levels of hormones	Treatment for 2-week	e.g., Gastrin and Motilin
Clinical symptoms evaluation	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.
Intestinal microbiome characteristics	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	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 inflammatory cytokines	Treatment for 2-week	e.g., TNF-α and IL-6

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China