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Completed

NCT Number: NCT04708405

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.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Helicobacter Pylori Infection Intestinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

High Institute of Public Health

Alexandria, 21561, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with inflammatory bowel disease condition

Exclusion criteria

  • Having irritable bowel disease
  • Being younger than 18 years

Treatment and study plan

observation

Other

Follow up and observe under standard of care given

Primary outcomes

  1. Change in the inflammatory bowel disease condition

    Time frame: 3 months

    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]

  2. Change in the inflammatory bowel disease condition

    Time frame: 3 months

    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. Change in the inflammatory bowel disease condition

    Time frame: 3 months

    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)]

  4. Change in the inflammatory bowel disease condition

    Time frame: 3 months

    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)]

  5. Change in the inflammatory bowel disease condition

    Time frame: 3 months

    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]

  6. Change in the inflammatory bowel disease condition

    Time frame: 3 months

    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)]

  7. Change in the inflammatory bowel disease condition

    Time frame: 3 months

    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)]

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Collaborators

  • High Institute of Public Health, Egypt

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 14, 2021
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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