Thyroid DiseaseNCT05542368
Study of Thyroid Status in Patients With IBD
An observational study of Thyroid Disease and Irritable Bowel Disease, run by Assiut University at 1 site in Egypt.
Trial summary
. The aim of the present study is to study thyroid state in patients with IBD Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Thyroid Disease, Irritable Bowel Disease
- What is being tested?
- Thyroid tests
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2022to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- -
Who cannot join
- 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 …..
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Thyroid State in Patients With Inflammatory Bowel Diseases
. The aim of the present study is to study thyroid state in patients with IBD
Read the detailed description
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.
- 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
- Conditions
- Thyroid Disease, Irritable Bowel Disease
- Being tested
- Thyroid tests
- Medical subject headings
- Thyroid Diseases, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid testsDiagnostic test
Also called Thyroid function test and thyroid antibodies
Thyroid function test TSH ,T3,T4 Thyroid antibody test anti TPO,antithyroglobulin
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Diagnostic Test: Thyroid tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of thyroid disorders in patients with IBD
By use of Thyroid function test (include T3-T4- TSH), thyroid antibodies and thyroid sonography
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study startDec 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesreen Hassan Mansour Ali, Assiut University
- Investigators
- Abo zaid Ali, assistant prof, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542368
- Sponsor's protocol ID
- thyroid state in IBD patients
- Status last verified
- Sep 2022
- First submitted
- 20 May 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Thyroid State in Patients With Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT05542368
- Acronym / sponsor ID
- thyroid state in IBD patients
- Conditions
- Thyroid Disease, Irritable Bowel Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
. The aim of the present study is to study thyroid state in patients with IBD
Detailed description
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.
- 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
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with IBD | – | Diagnostic Test: Thyroid testsAll 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 |
| Healty individuals as a control group | – | Diagnostic Test: Thyroid testsAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (6 listed)
- patients with
- Thyroid disease
- Acute or chronic kidney
- Acute or Chronic Liver Disease. Active Lupus -
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroid testsAlso: Thyroid function test and thyroid antibodiesThyroid function test TSH ,T3,T4 Thyroid antibody test anti TPO,antithyroglobulin | Diagnostic test | Healty individuals as a control group, Patients with IBD |
Primary outcome
Percentage of thyroid disorders in patients with IBD
Time frame: 1 year
By use of Thyroid function test (include T3-T4- TSH), thyroid antibodies and thyroid sonography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- nflammatory bowel disease severity and activity are correlated to thyroid gland nodularity, chronic nonthyroidal illness, and thyroid autoantibodies but not thyroid dysfunctionLink provided by the sponsor.
- Role of autoantibodies in the pathogenesis and association of endocrine autoimmune disordersLink provided by the sponsor.
- Autoimmune thyroid disease (Graves' disease and hashimoto's thyroiditis) in two patients with Crohn's disease: case reports and literature reviewLink provided by the sponsor.
- Simultaneous occurrence of inflammatory bowel disease and thyroid diseaseLink provided by the sponsor.
- Coexistence of Addison's disease, ulcerative colitis, hypothyroidism and pernicious anemiaLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abo zaid Ali, assistant prof principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Disease and Irritable Bowel Disease, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hassan, Resident (+201144971296, nisreenhassan6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of thyroid disorders in patients with IBD (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.