drugset / Trial / NCT04697641

Helicobacter Pylori Eradication in Functional Dyspepsia

NCT04697641 ↗

Completed 202 enrolled Sir Ganga Ram Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is designed to study benefit of eradicating Helicobacter Pylori in patients with functional dyspepsia as compared to symptomatic treatment only. Helicobacter pylori positive patients with Functional Dyspepsia will be divided into two study groups, one will receive Helicobacter pylori eradication therapy and other will receive symptomatic treatment. Symptom relief based on Likert scale will be compared in both groups.

Timeline

Start
2017-09-01
Primary completion
2019-05-31
Completion
2019-05-31

Outcome

Missed primary endpoint

paper Thirty-two patients in group 1 and 31 in group 2 had treatment success (31.7% vs. 30.7%, p=1.000). PMID 34708338 ↗

paper CONCLUSIONS: H. pylori eradication therapy does not provide additional benefit in symptom relief in patients with FD as compared with SMT. PMID 34708338 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 1000 mg —
Subject Clarithromycin Small molecule 500 mg —
Comparator Acotiamide Small molecule 100 mg —
Comparator Itopride Small molecule 50 mg —
Comparator Levosulpiride Small molecule 25 mg —
Background Pantoprazole Other / unclassified 40 mg —