Detection of Helicobacter Pylori in Ulcerative Colitis Pa... | NCT03172000

Studies
Detection of Helicobacter Pylori in Ulcerative Colitis Patients

NCT03172000

Sponsor

Tanta University

Status

Unknown status

Last Update Posted

May 31, 2017Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Inflammatory Bowel Diseases

Interventions

Colonoscopy and biopsy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Aug 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

May 27, 2017

First Submission Date that Met QC Criteria

May 30, 2017

First Posted Date

May 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2017

Last Update Posted Date

May 31, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Colonoscopy and biopsy	Active Comparator	IBD patients	Diagnostic Test: Colonoscopy and biopsy
Colonoscopic biopsy	No Intervention	Non IBD patients colonoscopic biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Colonoscopy and biopsy	Diagnostic Test	Colonoscopic biopsy were taken from the rectum, the sigmoid, descending, transverse, ascending colon, and the cecum of each patient.	Colonoscopy and biopsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with Helicobacter	Number of patients with Helicobacter	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

newly diagnosed ulcerative colitis

Exclusion Criteria:

Other diagnosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherief Abd-Elsalam, MD	Contact	00201147773440		Sheriefabdelsalam@yahoo.com
sherief Abd-Elsalam, Consultant	Contact	00201147773440	002	sheriefabdelsalam@yahoo.com

Overall Officials

Name	Affiliation	Role
Loai Mansour, MD	Tanta University Faculty of Medicine	Principal Investigator
Ferial El-kalla, MD	Tanta university Faculty of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta university - faculty of medicine	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003113	Colonoscopy
D001706	Biopsy

Ancestor Terms

ID	Term
D016099	Endoscopy, Gastrointestinal
D016145	Endoscopy, Digestive System
D003938	Diagnostic Techniques, Digestive System
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided