Back to resultsDetection of Helicobacter Pylori in Ulcerative Colitis Patients
Primary Purpose
Inflammatory Bowel Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Colonoscopy and biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Inflammatory Bowel Diseases
Eligibility Criteria
Inclusion Criteria:
- newly diagnosed ulcerative colitis
Exclusion Criteria:
- Other diagnosis
Sites / Locations
- Tanta university - faculty of medicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Colonoscopy and biopsy
Colonoscopic biopsy
Arm Description
IBD patients
Non IBD patients colonoscopic biopsy
Outcomes
Primary Outcome Measures
Number of patients with Helicobacter
Number of patients with Helicobacter
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03172000
Brief Title
Detection of Helicobacter Pylori in Ulcerative Colitis Patients
Official Title
Detection of Helicobacter Pylori in Colonic Tissue in Newly Diagnosed Ulcerative Colitis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Helicobacter pylori (H. pylori) infection is one of the most common infectious diseases in humans.
Detailed Description
Several bacterial and viral agents may have a role in the aetiology of IBD. In theory, H. pylori infection could be involved in IBD by inducing alterations in gastric and/or intestinal permeability or by causing immunological derangements resulting in absorption of antigenic material and autoimmunity via various immunological pathways.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Colonoscopy and biopsy
Arm Type
Active Comparator
Arm Description
IBD patients
Arm Title
Colonoscopic biopsy
Arm Type
No Intervention
Arm Description
Non IBD patients colonoscopic biopsy
Intervention Type
Diagnostic Test
Intervention Name(s)
Colonoscopy and biopsy
Intervention Description
Colonoscopic biopsy were taken from the rectum, the sigmoid, descending, transverse, ascending colon, and the cecum of each patient.
Primary Outcome Measure Information:
Title
Number of patients with Helicobacter
Description
Number of patients with Helicobacter
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
newly diagnosed ulcerative colitis
Exclusion Criteria:
Other diagnosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, MD
Phone
00201147773440
Email
Sheriefabdelsalam@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
sherief Abd-Elsalam, Consultant
Phone
00201147773440
Ext
002
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loai Mansour, MD
Organizational Affiliation
Tanta University Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ferial El-kalla, MD
Organizational Affiliation
Tanta university Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abdelrahman Kobtan, MD
Organizational Affiliation
Tanta University Faculty of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hanan Soliman, MD
Organizational Affiliation
Tanta University Faculty of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, MD
Organizational Affiliation
Tanta University Faculty of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Tanta university - faculty of medicine
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief M Abdelsalam, lecturer
Phone
00201095159522
Email
Sheriefabdelsalam@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Detection of Helicobacter Pylori in Ulcerative Colitis Patients
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