NCT05515887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 22, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

April 4, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

August 10, 2022

Last Update Submit

April 3, 2025

Conditions

DyspepsiaChild

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

Shenqu Xiaoshi Oral liquid

EXPERIMENTAL

Shenqu Xiaoshi Oral liquid will be taken orally.

Drug: Shenqu Xiaoshi Oral liquid

Interventions

Shenqu Xiaoshi Oral liquidDRUG

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.

Also known as: SXOL
Shenqu Xiaoshi Oral liquid

Eligibility Criteria

Age3 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 021, China

Location

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chundi Xu

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2022

First Posted

August 25, 2022

Study Start

November 22, 2022

Primary Completion

December 31, 2024

Study Completion

March 31, 2025

Last Updated

April 4, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)