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

Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05515887
• Other study ID #: SQXS20220325
• Status: Recruiting
• Phase: Phase 4
• Start date: November 22, 2022
• Est. completion date: March 25, 2024

Study information

• Verified date: November 2023
• Source: Ruijin Hospital
• Contact: Xinqiong Wang
• Phone: 0086-021-64370045
• Email: wxq11671[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 25, 2024
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child
• Dyspepsia

Intervention

Drug:
• Shenqu Xiaoshi Oral liquid
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.

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal microbiome characteristics	All subjects faeces will be collected and analyzed by high-throughput metagenomic sequencing to find the characteristics (e.g., the a and ß diversity, the abundance of changed species) and composition of intestinal microbiome.	Treatment for 2-week
Primary	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
Primary	Levels of hormones	e.g., Gastrin and Motilin	Treatment for 2-week
Primary	Levels of inflammatory cytokines	e.g., TNF-a and IL-6	Treatment for 2-week
Primary	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