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

NCT02465996 | Unknown DMC

• 1 other identifier: 2015SDU-QILU-G02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dyspepsia

Keywords

barrier dysfunction; functional dyspepsia; Confocal Laser Endomicroscopic; therapeutic response

Outcome Measures

Primary Outcomes (1)

• pCLE score

  Used to assess the gastric barrier dysfunction of FD patients

  within 1 hour after pCLE examination

Secondary Outcomes (2)

• Leeds dyspepsia questionaire

  baseline and 4th week

• Main dyspepsia symptom score

  baseline and 4th weeks

Study Arms (2)

postprandial distress syndrome (PDS)

OTHER

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; Drug: Puyuanhewei

epigastric pain syndrome (EPS)

OTHER

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; Drug: Puyuanhewei

Interventions

pCLE examination DEVICE

All FD patients received pCLE examination.

Also known as: prob-based confocal laser endomicroscopy examination

epigastric pain syndrome (EPS); postprandial distress syndrome (PDS)

Puyuanhewei DRUG

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.

Also known as: Puyanhewei capsule administration

epigastric pain syndrome (EPS); postprandial distress syndrome (PDS)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe liver, heart, or kidney diseases.
• Current or past evidence of uncontrolled diabetes mellitus, psychosomatic disorders, such as depressive and anxiety disorders, and drug or alcohol abuse.
• Pregnant or breastfeeding women.
• Inability to give informed consent.
• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Dyspepsia

Interventions

Organization and Administration

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Services Administration

Study Officials

• Yanqing Li

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanqing Li, MD.PhD.

CONTACT

86-531-82169236; liyanqing@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Qilu Hospital

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 9, 2015
• Study Start: July 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 9, 2015

Record last verified: 2015-06

Locations

CN (1)