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

Shandong University

Status: Unknown

Conditions: Dyspepsia

Treatments: Drug: Puyuanhewei; Device: pCLE examination

Study type: Interventional

Funder types: Other

Identifiers

NCT02465996

2015SDU-QILU-G02

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

postprandial distress syndrome (PDS)

Other group

Description:

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.

Treatment:

Device: pCLE examination

Drug: Puyuanhewei

epigastric pain syndrome (EPS)

Other group

Description:

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.

Treatment:

Device: pCLE examination

Drug: Puyuanhewei