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

NCT ID: NCT05515887

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-22
• Study Completion Date: 2025-03-31

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.

Conditions

Dyspepsia; Child

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Shenqu Xiaoshi Oral liquid

Shenqu Xiaoshi Oral liquid will be taken orally.

Group Type: EXPERIMENTAL

Shenqu Xiaoshi Oral liquid

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

SXOL

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chundi Xu

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SQXS20220325

Identifier Type: -

Identifier Source: org_study_id