Effect of H. Pylori Eradication on Alleviating Symptoms in Functional Dyspepsia Patients

Effect of H. Pylori Eradication on Alleviating Symptoms in Functional Dyspepsia Patients: A Multicenter, Comparative Study

In patients with Helicobacter pylori-positive functional dyspepsia, long-term follow-up for 6 months after standard triple therapy first-line eradication treatment, the rate of symptom disappearance and degree of improvement of functional dyspepsia were confirmed through changes in symptom scores and changes in drug usage, and eradication treatment The purpose of this study is to confirm the rate of symptom disappearance according to the results.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori-positive With Functional Dyspepsia
• Intervention / Treatment: Drug: K-CAB

• Study Type: Interventional
• Enrollment (Anticipated): 315
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Nam Suk Lee; Phone Number: 010-9437-4490; Email: namsuk2580@daum.net
• Study Contact Backup: Name: Jong Min Lee

Study Locations

• Korea, Republic of
  • Jeollabuk
    • Iksan, Jeollabuk, Korea, Republic of, 15865
      • Recruiting
      • Wonkwang University Hospital
      • Contact: Suck Chei Choi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female outpatients between the ages of 19 and 75
• Who have symptoms of functional dyspepsia (early fullness, postprandial discomfort, epigastric pain, epigastric soreness) that correspond to Rome criteria 4 (diagnostic criteria questionnaire)

Exclusion Criteria:

• Small intestine and large intestine disease within 6 months of the screening visit (Visit 1)
• liver, pancreatobiliary disease within 6 months of the screening visit (Visit 1)
• peptic ulcer within 6 months of the screening visit (Visit 1)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tegoprazan 50mg; single group	Drug: K-CAB; Tegoprazan 50 mg 1 tab twice daily Amoxicillin 500mg 2 cap twice daily Clarithromycin 500mg 1tab twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of disappearance of dyspepsia symptoms	Rate of disappearance of dyspepsia symptoms after 6 months of eradication treatment	Day 176

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement rate of dyspepsia symptoms	Change rate of dyspepsia symptoms after 3 months and 6 months of eradication treatment	Day 92, Day 176
Number of days of dyspepsia drug administration	Number of days of dyspepsia drug administration after 3 months and 6 months of eradication treatment compared to baseline	Day 92, Day 176

Collaborators and Investigators

• Sponsor: Wonkwang University Hospital
• Investigators: Principal Investigator: Suck Chei Choi, Wonkwang University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: KCAB_004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No