NCT03172000

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

2.4 years

First QC Date

May 27, 2017

Last Update Submit

May 30, 2017

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

  • Number of patients with Helicobacter

    Number of patients with Helicobacter

    6 months

Study Arms (2)

Colonoscopy and biopsy

ACTIVE COMPARATOR

IBD patients

Diagnostic Test: Colonoscopy and biopsy

Colonoscopic biopsy

NO INTERVENTION

Non IBD patients colonoscopic biopsy

Interventions

Colonoscopy and biopsyDIAGNOSTIC_TEST

Colonoscopic biopsy were taken from the rectum, the sigmoid, descending, transverse, ascending colon, and the cecum of each patient.

Colonoscopy and biopsy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • newly diagnosed ulcerative colitis

You may not qualify if:

  • Other diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university - faculty of medicine

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

ColonoscopyBiopsy

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresCytodiagnosisCytological TechniquesClinical Laboratory TechniquesSpecimen HandlingInvestigative Techniques

Study Officials

  • Loai Mansour, MD

    Tanta University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

  • Ferial El-kalla, MD

    Tanta university Faculty of Medicine

    PRINCIPAL INVESTIGATOR

  • Abdelrahman Kobtan, MD

    Tanta University Faculty of Medicine

    STUDY DIRECTOR

  • Hanan Soliman, MD

    Tanta University Faculty of Medicine

    STUDY DIRECTOR

  • Sherief Abd-Elsalam, MD

    Tanta University Faculty of Medicine

    STUDY CHAIR

Central Study Contacts

Sherief Abd-Elsalam, MD

CONTACT

00201147773440Sheriefabdelsalam@yahoo.com

sherief Abd-Elsalam, Consultant

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2017

First Posted

May 31, 2017

Study Start

March 1, 2017

Primary Completion

August 1, 2019

Study Completion

December 1, 2019

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

EG(1)