Helicobacter Pylori Eradication and Irritable Bowel Syndrome: A Prospective Study

August 11, 2020 updated by: Haidi Karam, Assiut University

Effect of Helicobacter Pylori Eradication on Symptoms and Quality of Life of Irritable Bowel Syndrome: A Prospective Study

H. Pylori is frequently observed in patients with irritable bowel syndrome(IBS). However, the effect of H. pylori eradication on IBS is not clear.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients with IBS symptoms using Rome IV criteria will be included. Testing for H. pylori will be done. Patients with H. pylori will receive triple therapy and followed after two weeks for eradication and assessment of IBS symptoms.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients newly diagnosed with IBS and H.pylori

Exclusion Criteria:

  • Patients received previous treatment of H.pylori
  • Patients receiving treatment for IBS.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient with IBS
Patients with IBS and positive H. pylori.
Drug: Triple therapy for H.pylori
Triple therapy of proton pump inhibitors, clarithromycin and metronidazole.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire for Rome IV criteria
Time Frame: 2 weeks
Symptoms of IBS
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life questionnaire
Time Frame: 2 weeks
Quality of life.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 10, 2020

Primary Completion (Anticipated)

November 10, 2020

Study Completion (Anticipated)

November 10, 2020

Study Registration Dates

First Submitted

August 3, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (Actual)

August 14, 2020

Study Record Updates

Last Update Posted (Actual)

August 14, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H. Pylori

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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