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

Primary Purpose

Dyspepsia, Child

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Shenqu Xiaoshi Oral liquid

About this trial

This is an interventional treatment trial for Dyspepsia

Eligibility Criteria

3 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Ruijin Hospital, Shanghai Jiaotong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Shenqu Xiaoshi Oral liquid

Arm Description

Shenqu Xiaoshi Oral liquid will be taken orally.

Outcomes

Primary Outcome Measures

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.

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.

Levels of hormones

e.g., Gastrin and Motilin

Levels of inflammatory cytokines

e.g., TNF-α and IL-6

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05515887

First Posted

August 10, 2022

Last Updated

December 13, 2022

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05515887

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 22, 2022 (Actual)

Primary Completion Date

December 25, 2023 (Anticipated)

Study Completion Date

March 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyspepsia, Child

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Shenqu Xiaoshi Oral liquid

Arm Type

Experimental

Arm Description

Shenqu Xiaoshi Oral liquid will be taken orally.

Intervention Type

Drug

Intervention Name(s)

Shenqu Xiaoshi Oral liquid

Other Intervention Name(s)

SXOL

Intervention Description

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.

Primary Outcome Measure Information:

Title

Intestinal microbiome characteristics

Description

Time Frame

Treatment for 2-week

Title

Intestinal microbiome metabolites

Description

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.

Time Frame

Treatment for 2-week

Title

Levels of hormones

Description

e.g., Gastrin and Motilin

Time Frame

Treatment for 2-week

Title

Levels of inflammatory cytokines

Description

e.g., TNF-α and IL-6

Time Frame

Treatment for 2-week

Title

Clinical symptoms evaluation

Description

Time Frame

Treatment for 1-week and 2-week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xinqiong Wang

Phone

0086-021-64370045

Ext

600905

wxq11671@rjh.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chundi Xu

Organizational Affiliation

Ruijin Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xinqiong Wang

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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