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

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.

Study Overview

• Status: Recruiting
• Conditions: Dyspepsia; Child
• Intervention / Treatment: Drug: Shenqu Xiaoshi Oral liquid

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xinqiong Wang; Phone Number: 600905 0086-021-64370045; Email: wxq11671@rjh.com.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 021
      • Recruiting
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Contact: Xinqiong Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shenqu Xiaoshi Oral liquid; Shenqu Xiaoshi Oral liquid will be taken orally.	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.; Other Names: SXOL

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Chundi Xu, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Estimated): December 25, 2023
• Study Completion (Estimated): March 25, 2024

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: SQXS20220325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No