Hepatobilliary Manifestations in Inflammatory Bowel Disease PatientsNCT04613479
Frequency of Hepatobilliary Manifestations in Patients With Inflammatory Bowel Disease
An observational study of Hepatobilliary Manifestations in Inflammatory Bowel Disease Patients, run by Assiut University.
Trial summary
Hepatobilliary manifestations as extraintestinal manifestations of IBD are sometimes underdiagnosed which can impair patient prognosis Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hepatobilliary Manifestations in Inflammatory Bowel Disease Patients
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Jun 2022
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: All patients diagnosed IBD either crohns or ulcerative, male or female, age above 18 years old.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
Hepatobilliary manifestations as extraintestinal manifestations of IBD are sometimes underdiagnosed which can impair patient prognosis
Read the detailed description
Non alcoholic fatty liver is aliver disease most commonly found in patient with IBD most commonly without intestinal activity.
On the other hand primary according cholangitis is the most common specific with IBD commonly with ulcerative colitis. and is commonly overlap with autoimmune hepatitis IBD therapy can also be a cause it can lead to hepatic toxicity and some drugs like ant TNF can cause hepatitis b virus activation.
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevelance of hepatobilliary manifestations in IBD patients
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 posted3 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatobilliary Manifestations in Inflammatory Bowel Disease PatientsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayam Fathy Nasr, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613479
- Sponsor's protocol ID
- Inflammatory bowel disease
- Status last verified
- Nov 2020
- First submitted
- 28 Oct 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Hepatobilliary Manifestations in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04613479
- Acronym / sponsor ID
- Inflammatory bowel disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 3 Nov 2020 (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.
Hepatobilliary manifestations as extraintestinal manifestations of IBD are sometimes underdiagnosed which can impair patient prognosis
Detailed description
Non alcoholic fatty liver is aliver disease most commonly found in patient with IBD most commonly without intestinal activity.
On the other hand primary according cholangitis is the most common specific with IBD commonly with ulcerative colitis. and is commonly overlap with autoimmune hepatitis IBD therapy can also be a cause it can lead to hepatic toxicity and some drugs like ant TNF can cause hepatitis b virus activation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients diagnosed IBD either crohns or ulcerative, male or female, age above 18 years old.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevelance of hepatobilliary manifestations in IBD patients
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatobilliary Manifestations in Inflammatory Bowel Disease Patients, run by Assiut University.
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 0 inclusion and 1 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 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Hussein Elamin (01004084187, sehshammam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevelance of hepatobilliary manifestations in IBD patients (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 13 Nov 2020.