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

NCT04708405 | Completed

• 1 other identifier: 622-2019
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases; Helicobacter Pylori Infection

Keywords

Inflammatory Bowel Diseases; Helicobacter Pylori; Egypt

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

Inflammatory bowel disease patients

Inflammatory bowel disease patients screened for Helicobacter Pylori Infection

Other: Observation

Interventions

Observation OTHER

Follow up and observe under standard of care given

Inflammatory bowel disease patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with inflammatory bowel disease condition

You may qualify if:

• Diagnosed with inflammatory bowel disease condition

You may not qualify if:

• Having irritable bowel disease
• Being younger than 18 years

Sponsors & Collaborators

• Alexandria University: lead
• High Institute of Public Health, Egypt: collaborator

Study Sites (1)

High Institute of Public Health

Alexandria, 21561, Egypt

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 14, 2021
• Study Start: September 10, 2019
• Primary Completion: October 10, 2020
• Study Completion: October 30, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Locations

EG (1)