Back to resultsHelicobacter Pylori Eradication and Irritable Bowel Syndrome: A Prospective Study
Primary Purpose
Irritable Bowel Syndrome
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Triple therapy for H.pylori
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient with IBS
Arm Description
Patients with IBS and positive H. pylori.
Outcomes
Primary Outcome Measures
Questionnaire for Rome IV criteria
Symptoms of IBS
Secondary Outcome Measures
Quality of life questionnaire
Quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04512898
Brief Title
Helicobacter Pylori Eradication and Irritable Bowel Syndrome: A Prospective Study
Official Title
Effect of Helicobacter Pylori Eradication on Symptoms and Quality of Life of Irritable Bowel Syndrome: A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 10, 2020 (Anticipated)
Primary Completion Date
November 10, 2020 (Anticipated)
Study Completion Date
November 10, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Patients with IBS and have H. pylori
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient with IBS
Arm Type
Experimental
Arm Description
Patients with IBS and positive H. pylori.
Intervention Type
Drug
Intervention Name(s)
Triple therapy for H.pylori
Intervention Description
Triple therapy of proton pump inhibitors, clarithromycin and metronidazole.
Primary Outcome Measure Information:
Title
Questionnaire for Rome IV criteria
Description
Symptoms of IBS
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Quality of life questionnaire
Description
Quality of life.
Time Frame
2 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Helicobacter Pylori Eradication and Irritable Bowel Syndrome: A Prospective Study
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