Association Between Helicobacter Pylori and Inflammatory Bowel Disease

NCT ID: NCT03820284

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2021-02-01

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 .

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

Conditions

Helicobacter Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A

Group A inflammatory bowel disease with helicobacter pylori infection

No interventions assigned to this group

Group B

Inflammatory bowel disease without helicobacter pylori infection

No interventions assigned to this group

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Bahaa osman taha

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bahaa Os Taha, Master of internal medicine

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Zain elabdeen Ah Sayed, Doctorate of internal medicine

Role: STUDY_DIRECTOR

Assiut

Alaa El Abdelmonem, Doctorate of internal medicine

Role: STUDY_CHAIR

Assiut University

Locations

Bahaa osman taha

Asyut, , Egypt

Countries

Egypt

Other Identifiers

L23457

Identifier Type: -

Identifier Source: org_study_id