Gastric Barrier Dysfunction of Functional Dyspepsia and Therapeutic Response to Puyuanhewei Detected by Endomicroscopy

Not Applicable

• Conditions: Dyspepsia
• Interventions: Device: pCLE examination; Drug: Puyuanhewei

• Registration Number: NCT02465996
• Lead Sponsor: Shandong University

Brief Summary

Functional dyspepsia might have impaired gastric mucosal dysfunction and Puyuanhewei may be helpful to improve the symptoms of FD.

Detailed Description

This study aimed to investigate the gastric mucosal dysfunction in functional dyspepsia (FD) and verify the efficacy of Puyuanhewei for treating FD and assess the relationship between gastric microalterations and therapeutic response by endomicroscopy.

Study Timeline

• Study Start: 2014-07
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2015-06-01
• Study First Submitted QC: 2015-06-04
• Last Update Submitted: 2015-06-04
• Study First Posted: 2015-06-09
• Last Update Posted: 2015-06-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Consecutive outpatients aged 18 to 75 years old.
2. FD patients defined by the Rome III classification.
3. Willing to choose pCLE and no organic diseases.

Exclusion Criteria

1. Severe liver, heart, or kidney diseases.
2. Current or past evidence of uncontrolled diabetes mellitus, psychosomatic disorders, such as depressive and anxiety disorders, and drug or alcohol abuse.
3. Pregnant or breastfeeding women.
4. Inability to give informed consent.
5. Use of nonsteroidal anti-inflammatory drugs, proton pump inhibitors, H2-receptor antagonists, antacids, prokinetics, or other injurious drugs (antibiotics, and steroids) in the prior two weeks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
postprandial distress syndrome (PDS)	pCLE examination	FD patients fulfilled Rome III criteria were subclassified into postprandial distress syndrome (PDS) or epigastric pain syndrome (EPS). pCLE examination was performed in PDS patients, and then those who were willing to receive Puyuanhewei to treat FD were given 4 pills three times a day for 4 weeks after pCLE examination.
postprandial distress syndrome (PDS)	Puyuanhewei	FD patients fulfilled Rome III criteria were subclassified into postprandial distress syndrome (PDS) or epigastric pain syndrome (EPS). pCLE examination was performed in PDS patients, and then those who were willing to receive Puyuanhewei to treat FD were given 4 pills three times a day for 4 weeks after pCLE examination.
epigastric pain syndrome (EPS)	pCLE examination	pCLE examination was performed in EPS patients, and then those who were willing to receive Puyuanhewei to treat FD were given 4 pills three times a day for 4 weeks after pCLE examination.
epigastric pain syndrome (EPS)	Puyuanhewei	pCLE examination was performed in EPS patients, and then those who were willing to receive Puyuanhewei to treat FD were given 4 pills three times a day for 4 weeks after pCLE examination.

Primary Outcome Measures

Name	Time	Method
pCLE score	within 1 hour after pCLE examination	Used to assess the gastric barrier dysfunction of FD patients

Secondary Outcome Measures

Name	Time	Method
Leeds dyspepsia questionaire	baseline and 4th week	Used to describe the change of severity of FD from baseline to the 4th week during the treatment
Main dyspepsia symptom score	baseline and 4th weeks	Used to describe the change of severity and frequency of despepsia symptoms from baseline to the 4th week during the treatment

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China