Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2020
CompletedFirst Posted
Study publicly available on registry
June 26, 2020
CompletedStudy Start
First participant enrolled
June 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2021
CompletedJune 26, 2020
June 1, 2020
1.3 years
June 22, 2020
June 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Symptom of dyspepsia
at 3 months, and 6 months
Eradication of helicobacter pylori
at 3 months
Histologic finding of UGI tract
at initial and 3 months
Study Arms (1)
HP eradication group
EXPERIMENTALHP eradication group Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days
Interventions
Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days
Eligibility Criteria
You may qualify if:
- Patients who has diagnosed with functional dyspesia by Rome IV criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kee Wook Jung, MD, PhD
Asan Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 22, 2020
First Posted
June 26, 2020
Study Start
June 30, 2020
Primary Completion
October 30, 2021
Study Completion
October 30, 2021
Last Updated
June 26, 2020
Record last verified: 2020-06