Association Between Helicobacter Pylori and Inflammatory Bowel Disease

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 .

Study Overview

• Status: Completed
• Conditions: Helicobacter Infections

Detailed Description

PATIENT AND METHOD :

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 .

1. Thorough medical history and full clinical examination will be taken from all patient including

   -Personal history focus on special habit especially smoking

   -documented previous history for H.pylori eradication

   • Onset and duration of inflammatory bowel disease
   • current medication
   • presence of any extra intestinal manifestation of Inflammatory bowel disease
   • presence of any complications from Inflammatory bowel disease

2. Investigation :

   -All patients with inflammatory bowel disease will be tested for presence or absence of H.PYLORI by histological examination of endoscopically biopsied gastric mucosa

   -his to logical examination of colonic mucosal every 3 months

   -complete blood count

   -serum albumin

   -c reactive protein, erythrocyte sedimentation rate (ESR).

   -fecal calprotectin if possible

   • assess the severity of among both group (A,B) every 3 month for 2years. ulcerative by Mayo Score/Ulcerative Colitis Disease Activity Index and Crohn's disease by Montreal classifications for Crohn's Disease .

   Mayo Score/Ulcerative Colitis Disease Activity 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

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Bahaa Osman Taha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inflammatory bowel disease patients with or without H.pylori infection

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group A; Group A inflammatory bowel disease with helicobacter pylori infection
Group B; Inflammatory bowel disease without helicobacter pylori infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Bahaa Os Taha, Master of internal medicine, Assiut University; Study Director: Zain elabdeen Ah Sayed, Doctorate of internal medicine, Assiut; Study Chair: Alaa El Abdelmonem, Doctorate of internal medicine, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: January 19, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Inflammatory Bowel Diseases; Helicobacter Infections
• Other Study ID Numbers: L23457

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No