the Relationship Between Helicobacter Pylori Infection and Irritable Bowel Syndrome

April 14, 2021 updated by: Reham Mohy El-Din Kamel, Sohag University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

outpatient clinic patients

Description

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 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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 2
normal
Diagnostic test: H. pylori stool antigen
using H. pylori antigen kits in stool
Group 1
patients with Irritable Bowel Syndrome
Diagnostic test: H. pylori stool antigen
using H. pylori antigen kits in stool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of irritable bowel syndrome patients who had H.pylori infection
Time Frame: through study completion, an average of 1 year
H.pylori stool antigen kits
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Sohag 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)

May 25, 2021

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-04-03

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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