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NCT04847401 Clinical Trial

the Relationship Between Helicobacter Pylori Infection and Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:
Evaluation of the Relationship Between Helicobacter Pylori Infection and Irritable Bowel Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04847401
Other study ID # Soh-Med-21-04-03
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 25, 2021
Est. completion date January 1, 2022

Study information
Verified date April 2021
Source Sohag University
Contact Reham Mohy Kamel, MBBCh
Phone 01274648573
Email reham.amin@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Evaluating any possible relationship between irritable bowel syndrome occurrence and Helicobacter pylori infection

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date January 1, 2022
Est. primary completion date November 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - All patients will be selected according to Rome IV criteria for the diagnosis of IBS, which include: Recurrent abdominal pain at least 1 day/week in the last 3 months, with two or more of the following criteria: - Related to defecation - Associated with a change in frequency of stool - Associated with a change in form of stool. Criteria achieved for the last 3 months with symptom onset at least 6 months before diagnosis Exclusion Criteria: - • Rectal bleeding - Anemia - Weight loss - Onset after 50 years of age - Recent antibiotic use - Abnormal abdominal examination (organomegaly, lump) - Family history of colorectal cancer. - Family history of inflammatory bowel disease, or celiac disease.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• H. pylori stool antigen
using H. pylori antigen kits in stool

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sohag University

Outcome
Type Measure Description Time frame Safety issue
Primary number of irritable bowel syndrome patients who had H.pylori infection H.pylori stool antigen kits through study completion, an average of 1 year
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