Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia

Asan Medical Center

Status and phase: Unknown; Phase 4

Conditions: Dyspepsia

Treatments: Drug: Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days

Study type: Interventional

Funder types: Other

Identifiers

NCT04449185

2020-0621

Details and patient eligibility

About

The aims of the investigators' study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.

Full description

Accumulating evidence shows that Helicobacter pylori protects against some metabolic and immunological diseases in which the development of these diseases coincide with temporal or permanent dysbiosis. Helicobacter pylori eradication therapy has the potential to improve symptoms of functional dyspepsia. The aims of our study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who has diagnosed with functional dyspesia by Rome IV criteria

Exclusion criteria

• Known GI malignancy
• Previous Helicobater pylori eradication history
• Severe systemic disease
• Previous GI surgery
• Uncorrectable coagulopathy: INR > 1.5 or platelet < 50,000/ml
• Pregnant or breastfeeding women
• Atrophic gastritis, open type

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

HP eradication group

Experimental group

Description:

HP eradication group Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days

Treatment:

Drug: Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days