NCT05542368

Brief Summary

. The aim of the present study is to study thyroid state in patients with IBD

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
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

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

First Submitted

Initial submission to the registry

May 20, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

2 years

First QC Date

May 20, 2022

Last Update Submit

September 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of thyroid disorders in patients with IBD

    By use of Thyroid function test (include T3-T4- TSH), thyroid antibodies and thyroid sonography

    1 year

Study Arms (2)

Patients with IBD

All patients were subjected to history taking and physical examination with emphasis on history of autoimmune disease, extraintestinal manifestations of IBD, neck examination for goiter, symptoms and signs of thyroid dysfunction. b) Laboratory investigations: Thyroid function test (include T3-T4- TSH) * ESR - CRP - thyroid antibodies: (Anti TPO -Anti Thyroglobulin) c)-Imaging: * Neck U/S on thyroid gland to identify patients with ultrasonographic evidence of autoimmune thyroiditis (diffuse hypoechogenicity or heterogenicity echotexture or both) and to detect thyroid nodularity. d ) Endoscopic findings regarding diagnosis of IBD confirmed by histopathological examination

Diagnostic Test: Thyroid tests

Healty individuals as a control group

All patients were subjected to history taking and physical examination with emphasis on history of autoimmune disease, extraintestinal manifestations of IBD, neck examination for goiter, symptoms and signs of thyroid dysfunction. b) Laboratory investigations: Thyroid function test (include T3-T4- TSH) * ESR - CRP - thyroid antibodies: (Anti TPO -Anti Thyroglobulin) c)-Imaging: * Neck U/S on thyroid gland to identify patients with ultrasonographic evidence of autoimmune thyroiditis (diffuse hypoechogenicity or heterogenicity echotexture or both) and to detect thyroid nodularity.

Diagnostic Test: Thyroid tests

Interventions

Thyroid testsDIAGNOSTIC_TEST

Thyroid function test TSH ,T3,T4 Thyroid antibody test anti TPO,antithyroglobulin

Also known as: Thyroid function test and thyroid antibodies
Healty individuals as a control groupPatients with IBD

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with IBD admitted at Assiut University Hospital, Al Rajhi Liver Hospital or attending IBD outpatient clinic. a. Inclusion criteria: All patients with IBD Exclusion criteria: patients with * Thyroid disease * Acute or chronic kidney * Acute or Chronic Liver Disease. Active Lupus - * Malignancy * patients taking medications that affect thyroid function as rifampin, amiodarone

You may not qualify if:

  • patients with
  • Thyroid disease
  • Acute or chronic kidney
  • Acute or Chronic Liver Disease. Active Lupus -
  • Malignancy
  • patients taking medications that affect thyroid function as rifampin, amiodarone …..

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Links

MeSH Terms

Conditions

Thyroid DiseasesIrritable Bowel Syndrome

Interventions

Thyroid Function Tests

Condition Hierarchy (Ancestors)

Endocrine System DiseasesColonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, EndocrineDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Abo zaid Ali, assistant prof

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abu Bakr Elisily, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2022

First Posted

September 15, 2022

Study Start

December 1, 2022

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

September 15, 2022

Record last verified: 2022-09

Locations