the Relationship Between Helicobacter Pylori Infection and Irritable Bowel Syndrome

• Conditions: Irritable Bowel Syndrome
• Interventions: Diagnostic Test: H. pylori stool antigen

• Registration Number: NCT04847401
• Lead Sponsor: Sohag University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-14
• Last Update Submitted: 2021-04-14
• Study First Posted: 2021-04-19
• Last Update Posted: 2021-04-19
• Study Start: 2021-05-25
• Primary Completion: 2021-11-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	H. pylori stool antigen	patients with Irritable Bowel Syndrome
Group 2	H. pylori stool antigen	normal

Primary Outcome Measures

Name	Time	Method
number of irritable bowel syndrome patients who had H.pylori infection	through study completion, an average of 1 year	H.pylori stool antigen kits