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

Phase 4

• Conditions: Dyspepsia
• Interventions: Drug: Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days

• Registration Number: NCT04449185
• Lead Sponsor: Asan Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-24
• Last Update Submitted: 2020-06-24
• Study First Posted: 2020-06-26
• Last Update Posted: 2020-06-26
• Study Start: 2020-06-30
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change of gut microbiome	at 3 months, and 6 months	Change of gut microbiome at 3 months, and 6 months regardless of Helicobater positive or negative

Secondary Outcome Measures

Name	Time	Method
Eradication of helicobacter pylori	at 3 months	Eradication rate of helicobacter pylori at 3 months
Histologic finding of UGI tract	at initial and 3 months	Change of accumulationof inflammatory cells, eosinophils of esophagus, stomachm duodenal mucosal biopsy
Symptom of dyspepsia	at 3 months, and 6 months	Improvement of NDI-K, HADS,SEQ-FD at 3 and 6 months