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

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

Study Overview

• Status: Unknown
• Conditions: Dyspepsia
• Intervention / Treatment: Device: pCLE examination; Drug: Puyuanhewei

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Department of Gastroenterology, Qilu Hospital, Shandong University
      • Contact: Yanqing Li, MD.PhD.; Phone Number: 82169508 86-531-82169236; Email: liyanqing@sdu.edu.cn
      • Sub-Investigator: Rui Ji, MD. PhD.
      • Sub-Investigator: Kang Jiang, MD.
      • Sub-Investigator: Xiu-Li Zuo, MD. PhD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: postprandial distress syndrome (PDS); 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.	Device: pCLE examination; All FD patients received pCLE examination.; Other Names: prob-based confocal laser endomicroscopy examination; Drug: Puyuanhewei; FD patients willing to receive Puyuanhewei were given 4 pills three times a day regardless of PDS or EPS for 4 weeks after pCLE examination.; Other Names: Puyanhewei capsule administration
Other: epigastric pain syndrome (EPS); 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.	Device: pCLE examination; All FD patients received pCLE examination.; Other Names: prob-based confocal laser endomicroscopy examination; Drug: Puyuanhewei; FD patients willing to receive Puyuanhewei were given 4 pills three times a day regardless of PDS or EPS for 4 weeks after pCLE examination.; Other Names: Puyanhewei capsule administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCLE score	Used to assess the gastric barrier dysfunction of FD patients	within 1 hour after pCLE examination

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shandong University

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: June 1, 2015
• First Submitted That Met QC Criteria: June 4, 2015
• First Posted (Estimate): June 9, 2015

Study Record Updates

• Last Update Posted (Estimate): June 9, 2015
• Last Update Submitted That Met QC Criteria: June 4, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: functional dyspepsia; therapeutic response; barrier dysfunction; Confocal Laser Endomicroscopic
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: 2015SDU-QILU-G02