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

June 24, 2020 updated by: Kee Wook Jung, Asan Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HP eradication group

HP eradication group

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of gut microbiome
Time Frame: at 3 months, and 6 months
Change of gut microbiome at 3 months, and 6 months regardless of Helicobater positive or negative
at 3 months, and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Kee Wook Jung, MD, PhD, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 30, 2020

Primary Completion (Anticipated)

October 30, 2021

Study Completion (Anticipated)

October 30, 2021

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (Actual)

June 26, 2020

Study Record Updates

Last Update Posted (Actual)

June 26, 2020

Last Update Submitted That Met QC Criteria

June 24, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0621

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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