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Helicobacter Pylori Eradication and Irritable Bowel Syndrome: A Prospective Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04512898
Recruitment Status : Not yet recruiting
First Posted : August 14, 2020
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
Haidi Karam, Assiut University

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

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: Triple therapy for H.pylori Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients with IBS and have H. pylori
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Helicobacter Pylori Eradication on Symptoms and Quality of Life of Irritable Bowel Syndrome: A Prospective Study
Estimated Study Start Date : August 10, 2020
Estimated Primary Completion Date : November 10, 2020
Estimated Study Completion Date : November 10, 2020
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Questionnaire for Rome IV criteria [ Time Frame: 2 weeks ]
    Symptoms of IBS


Secondary Outcome Measures :
  1. Quality of life questionnaire [ Time Frame: 2 weeks ]
    Quality of life.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients newly diagnosed with IBS and H.pylori

Exclusion Criteria:

  • Patients received previous treatment of H.pylori
  • Patients receiving treatment for IBS.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Haidi Karam, Lecturer of Tropical Medicine and Gastroenterology, Assiut University
ClinicalTrials.gov Identifier: NCT04512898    
Other Study ID Numbers: H. Pylori
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
 Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases