The Relationship Between Helicobacter Pylori Infection and Inflammatory Bowel Diseases: A Real-life Observation

Numerous epidemiological studies have investigated the association between Helicobacter pylori (H. pylori) infection and inflammatory bowel disease (IBD) with various conflicting results. The main objective of this study is to further explore the possible association between H. pylori infection and IBD and its impact on disease course. The investigators sought to conduct a prospective observational study and enroll a total of 182 IBD patients who were screened for H. pylori infection. All the participants will be clinically evaluated at the initial visit and bimonthly for 3 months. Several factors will be explored such are diet, physical activity, life style and considering specific environmental exposures that impact the development of disease or its relapse.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Helicobacter Pylori Infection
• Intervention / Treatment: Other: Observation

• Study Type: Observational
• Enrollment (Actual): 182

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21561
    • High Institute of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with inflammatory bowel disease condition

Description

Inclusion Criteria:

• Diagnosed with inflammatory bowel disease condition

Exclusion Criteria:

• Having irritable bowel disease
• Being younger than 18 years

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Inflammatory bowel disease patients; Inflammatory bowel disease patients screened for Helicobacter Pylori Infection	Other: Observation; Follow up and observe under standard of care given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the inflammatory bowel disease condition	Change in the inflammatory bowel disease condition during follow up as measured by disease related symptoms [weight loss where weight will be measured and reported in kilograms]	3 months
Change in the inflammatory bowel disease condition	Change in the inflammatory bowel disease condition during follow up as measured by frequency of disease related symptoms [number of attacks disease related symptoms per day (diarrhea, tenesmus, bleeding per rectum, abdominal pain, indigestion)]	3 months
Change in the inflammatory bowel disease condition	Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in serum samples [C reactive protein (IU/ml)]	3 months
Change in the inflammatory bowel disease condition	Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in serum samples [Hemoglobin (g/dl)]	3 months
Change in the inflammatory bowel disease condition	Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in blood samples [Complete blood picture including white blood count per cmm, platelets count per cmm]	3 months
Change in the inflammatory bowel disease condition	Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in serum samples [ESR (mm/hr)]	3 months
Change in the inflammatory bowel disease condition	Change in the inflammatory bowel disease condition during follow up as measured by changes in baseline laboratory parameters measured in serum samples [Fasting blood glucose (mg/dl)]	3 months

Collaborators and Investigators

• Sponsor: Alexandria University
• Collaborators: High Institute of Public Health, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Actual): October 10, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Diseases; Egypt; Helicobacter Pylori
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Inflammatory Bowel Diseases; Intestinal Diseases; Helicobacter Infections
• Other Study ID Numbers: 622-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No