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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04708405
• Other study ID #: 622-2019
• Status: Completed
• Start date: September 10, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: January 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: October 30, 2020
• Est. primary completion date: October 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Diagnosed with inflammatory bowel disease condition

Exclusion Criteria:

• Having irritable bowel disease

• Being younger than 18 years

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Other:
• Observation
Follow up and observe under standard of care given

Locations

Country	Name	City	State
Egypt	High Institute of Public Health	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Alexandria University	High Institute of Public Health, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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