Status:

COMPLETED

Helicobacter Pylori Eradication in Functional Dyspepsia

Lead Sponsor:

Sir Ganga Ram Hospital

Conditions:

Dyspepsia

Helicobacter Pylori Infection

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 F...

Detailed Description

Functional dyspepsia (FD), is a common problem with many associations. About 50% of the patients with FD have coexistent Helicobacter pylori (HP) associated gastritis. Many investigators have tried t...

Eligibility Criteria

Inclusion

  • Age \> 18 years
  • Patients fulfilling the ROME-IV criteria of Functional Dyspepsia
  • Signed informed consent.

Exclusion

  • Pregnant and lactating females
  • Patients with predominant symptoms of heartburn or irritable bowel syndrome; alarm symptoms; history of peptic ulcer, upper gastrointestinal tract surgery, or biliary colic
  • Previous treatment for eradication of H pylori.
  • Known allergies to study medication or alcohol or drug abuse.
  • Use of antibiotics or bismuth during the 4 weeks before enrolment, proton pump inhibitors during the 2 weeks before enrolment, or treatment with histamine-2 receptor blockers in the week before enrolment will not be permitted.
  • Patients unable to answer the study questionnaires.
  • Patients unwilling or unable to provide consent.
  • Patient on HIV/AIDS medications, blood thinners, clopidogrel, cyclosporine, digoxin, iron supplements, fluconazole or ketoconazole, probenecid, rifabutin, sildenafil, tacrolimus, theophylline, sulfa drugs, cholesterol-lowering medicines, heart rhythm medications, sedatives, seizure medications, or tetracycline antibiotics.

Key Trial Info

Start Date :

September 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 31 2019

Estimated Enrollment :

202 Patients enrolled

Trial Details

Trial ID

NCT04697641

Start Date

September 1 2017

End Date

May 31 2019

Last Update

January 14 2021

Active Locations (1)

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Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital

New Delhi, India, 110060