Back to resultsChange of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia
Primary Purpose
Dyspepsia
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days
Sponsored by
About this trial
This is an interventional treatment trial for Dyspepsia focused on measuring Dyspepsia, Microbiome, Eradication therapy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HP eradication group
Arm Description
HP eradication group Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days
Outcomes
Primary Outcome Measures
Change of gut microbiome
Change of gut microbiome at 3 months, and 6 months regardless of Helicobater positive or negative
Secondary Outcome Measures
Symptom of dyspepsia
Improvement of NDI-K, HADS,SEQ-FD at 3 and 6 months
Eradication of helicobacter pylori
Eradication rate of helicobacter pylori at 3 months
Histologic finding of UGI tract
Change of accumulationof inflammatory cells, eosinophils of esophagus, stomachm duodenal mucosal biopsy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04449185
Brief Title
Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia
Official Title
Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2020 (Anticipated)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
October 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
Keywords
Dyspepsia, Microbiome, Eradication therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HP eradication group
Arm Type
Experimental
Arm Description
HP eradication group
Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days
Intervention Type
Drug
Intervention Name(s)
Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days
Intervention Description
Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days
Primary Outcome Measure Information:
Title
Change of gut microbiome
Description
Change of gut microbiome at 3 months, and 6 months regardless of Helicobater positive or negative
Time Frame
at 3 months, and 6 months
Secondary Outcome Measure Information:
Title
Symptom of dyspepsia
Description
Improvement of NDI-K, HADS,SEQ-FD at 3 and 6 months
Time Frame
at 3 months, and 6 months
Title
Eradication of helicobacter pylori
Description
Eradication rate of helicobacter pylori at 3 months
Time Frame
at 3 months
Title
Histologic finding of UGI tract
Description
Change of accumulationof inflammatory cells, eosinophils of esophagus, stomachm duodenal mucosal biopsy
Time Frame
at initial and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kee Wook Jung, MD, PhD
Phone
821026778856
Email
jung.keewook30@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ga Hee Kim, MD, PhD
Phone
821028732884
Email
smallgh@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kee Wook Jung, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia
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