NCT05002166

Brief Summary

Clinical Characteristics and Risk factors of Children Suffering from Inflammatory Bowel Diseases At Assiut University Children Hospital

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
14mo left

Started Aug 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress82%
Aug 2021Jul 2027

First Submitted

Initial submission to the registry

July 20, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

August 5, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2027

Last Updated

August 12, 2021

Status Verified

July 1, 2021

Enrollment Period

6 years

First QC Date

July 20, 2021

Last Update Submit

August 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical characteristics and risk factors for IBD

    To study the natural history, patterns, and clinical characteristics (as history of real bleeding, mucus or blood in the stool, diarrhea, abdominal pain ,vomiting)and risk factors of inflammatory bowel diseases (IBD) at Assiut University Children Hospital

    6 months

Study Arms (1)

Children aged less than 18 years with a confirmed diagnosis of IBD.

All patients admitted with inflammatory bowel disease will be subjected to: 1. History: including name, age ,sex ,family history, consanguinity, history of rectal bleeding, mucus or blood in the stool, diarrhea, abdominal pain ,vomiting ,nausea and loss of appetite. 2. Examination: including general examination, chest, cardiac, abdominal and neurological examination 3. Investigation:including labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.

Other: labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.

Interventions

labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.

Children aged less than 18 years with a confirmed diagnosis of IBD.

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

All patients admitted with inflammatory bowel disease

You may qualify if:

  • \- Children aged less than 18 years with a confirmed diagnosis of IBD.

You may not qualify if:

  • Children with colitis other than IBD or children with systemic diseases affecting GIT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christine zaghloul noos

Asyut, 23123, Egypt

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Shereen Mansour, Lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Zaghloul, Resident

CONTACT

Maher Mokhtar, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 20, 2021

First Posted

August 12, 2021

Study Start

August 5, 2021

Primary Completion (Estimated)

July 20, 2027

Study Completion (Estimated)

July 20, 2027

Last Updated

August 12, 2021

Record last verified: 2021-07

Locations