ClinicalTrials.gov
ClinicalTrials.gov Menu

Detection of Helicobacter Pylori in Ulcerative Colitis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03172000
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Tanta University

Brief Summary:
Helicobacter pylori (H. pylori) infection is one of the most common infectious diseases in humans.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Diagnostic Test: Colonoscopy and biopsy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Detection of Helicobacter Pylori in Colonic Tissue in Newly Diagnosed Ulcerative Colitis Patients
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Colonoscopy and biopsy
IBD patients
Diagnostic Test: Colonoscopy and biopsy
Colonoscopic biopsy were taken from the rectum, the sigmoid, descending, transverse, ascending colon, and the cecum of each patient.

No Intervention: Colonoscopic biopsy
Non IBD patients colonoscopic biopsy



Primary Outcome Measures :
  1. Number of patients with Helicobacter [ Time Frame: 6 months ]
    Number of patients with Helicobacter



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • newly diagnosed ulcerative colitis

Exclusion Criteria:

  • Other diagnosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172000


Contacts
Contact: Sherief Abd-Elsalam, MD 00201147773440 Sheriefabdelsalam@yahoo.com
Contact: sherief Abd-Elsalam, Consultant 00201147773440 ext 002 sheriefabdelsalam@yahoo.com

Locations
Egypt
Tanta university - faculty of medicine Recruiting
Cairo, Egypt
Contact: Sherief M Abdelsalam, lecturer    00201095159522    Sheriefabdelsalam@yahoo.com   
Sponsors and Collaborators
Tanta University
Investigators
Principal Investigator: Loai Mansour, MD Tanta University Faculty of Medicine
Principal Investigator: Ferial El-kalla, MD Tanta university Faculty of Medicine
Study Director: Abdelrahman Kobtan, MD Tanta University Faculty of Medicine
Study Director: Hanan Soliman, MD Tanta University Faculty of Medicine
Study Chair: Sherief Abd-Elsalam, MD Tanta University Faculty of Medicine

Responsible Party: Tanta University
ClinicalTrials.gov Identifier: NCT03172000     History of Changes
Other Study ID Numbers: IBD Helicobacter
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases