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

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04449185
• Other study ID #: 2020-0621
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 30, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: June 2020
• Source: Asan Medical Center
• Contact: Kee Wook Jung, MD, PhD
• Phone: 821026778856
• Email: jung.keewook30[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of gut microbiome	Change of gut microbiome at 3 months, and 6 months regardless of Helicobater positive or negative	at 3 months, and 6 months
Secondary	Symptom of dyspepsia	Improvement of NDI-K, HADS,SEQ-FD at 3 and 6 months	at 3 months, and 6 months
Secondary	Eradication of helicobacter pylori	Eradication rate of helicobacter pylori at 3 months	at 3 months
Secondary	Histologic finding of UGI tract	Change of accumulationof inflammatory cells, eosinophils of esophagus, stomachm duodenal mucosal biopsy	at initial and 3 months