Association Between Helicobacter Pylori and Inflammatory Bowel Disease

NCT03820284 | Completed DMC

• 1 other identifier: L23457
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Helicobacter pylori has been linked to a variety of gastric and extra gastric diseases. Chronic infection with H. pylori causes histologically evident gastritis in all colonized individuals and is the predominant risk factor for gastric and duodenal ulcers as well as gastric adenocarcinoma. However, increasingly robust experimental and epidemiological evidence suggests that H. pylori may at the same time be beneficial to its carriers, as it efficiently prevents allergic disorders and chronic inflammatory conditions . Inflammatory bowel disease (IBD) is characterized by chronic, nonspecific intestinal inflammation with an unexplained pathology and an alternating relapsing and remitting clinical progression. IBD is divided into two subtypes: ulcerative colitis (UC) and Crohn's disease (CD). Most studies in the IBD field attribute its etiology to the complex interactions among immune dysfunction, genetic susceptibility of the host, and environmental risk factors. Since the twenty-first century, improving hygienic conditions and socioeconomic status have reduced the H. pylori infection rate and this trend has concurrently been accompanied by an increased IBD incidence in most countries Numerous studies have reported a lower H. pylori infection rate in patients with CD and/or UC than in non-IBD control individuals. although a small number of studies showed no significant association .Recently, emerging epidemiologic studies and animal experiments revealed an inverse correlation between H. pylori infection and IBD onset, suggesting that H. pylori colonization exerts a special protective effect on autoimmune diseases observation Cross sectional study will be conducted at assuit university hospitals on all patients with inflammatory disease to detect the prevalence of helicobacter pylori among them .Then the examined patients will be divided in to two group receiving the same medication group A : inflammatory bowel disease patient with H.PYLORI group B: inflammatory bowel disease Patient without H.PYLORI longitudinal study will be conducted to both group to study the clinical outcomes in both group .

Conditions

Helicobacter Infections

Outcome Measures

Primary Outcomes (3)

• prevalance of H.pylori among patients with inflammatory bowel disease

  Number of patient with inflammatory bowel disease with H.pylori infection

  One years

• Mayo score activity index among ulcerative colitis patients with H.pylori and without H.pylori

  Stool frequency 0 = Normal 1 = 1-2 stools/day more than normal 2 = 3-4 stools/day more than normal 3 = 4 stools/day more than normal Rectal bleeding 0 = None 1 = Visible blood with stool less than half the time 2 = Visible blood with stool half of the time or more 3 = Passing blood alone Mucosal appearance at endoscopy 0 = Normal or inactive disease 1 = Mild disease (erythema, decreased vascular pattern, mild friability) 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions) 3 = Severe disease (spontaneous bleeding, ulceration) Physician rating of disease activity 0 = Normal 1 = Mild 2 = Moderate 3 = Severe

  Two years

• Mucosal healing among inflammatory bowel disease with H.pylori and without H.pylori

  Histological examination of the biopsied colonic mucosal every 3 months in both groups

  1years

Study Arms (2)

Group A

Group A inflammatory bowel disease with helicobacter pylori infection

Group B

Inflammatory bowel disease without helicobacter pylori infection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inflammatory bowel disease patients with or without H.pylori infection

You may qualify if:

• all inflammatory bowel disease at assiut university will be included and examined in cross sectional study for detection of presence of H.pylori in one year 2019-2020 .then the examined patients will be divided in two group A ,B according to presence or absence of H pylori . Both group will be studied in cohort study for two years

You may not qualify if:

• patients with history of administration of proton pump inhibitor or antibiotics with in eight weeks .
• patients with history of recent upper gastrointestinal bleeding

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Bahaa osman taha

Asyut, Egypt

Location

MeSH Terms

Conditions

Helicobacter Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Bahaa Os Taha, Master of internal medicine

  Assiut University

  PRINCIPAL INVESTIGATOR

• Zain elabdeen Ah Sayed, Doctorate of internal medicine

  Assiut

  STUDY DIRECTOR

• Alaa El Abdelmonem, Doctorate of internal medicine

  Assiut University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 19, 2019
• First Posted: January 29, 2019
• Study Start: February 1, 2019
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2021
• Last Updated: June 30, 2021

Record last verified: 2021-06

Locations

EG (1)