Inflammatory Bowel DiseasesNCT07387588
Anemia as Predictor of Outcome in IBD Pateints in Assuit University Hospitals
An observational study of Inflammatory Bowel Diseases, run by Assiut University.
Trial summary
Inflammatory bowel diseases (IBD), encompassing ulcerative colitis (UC) and Crohn's disease (CD), are chronic, relapsing inflammatory disorders of the gastrointestinal tract with significant morbidity and impact on patients' quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years old) diagnosed with inflammatory bowel diseases (ulcerative colitis or Crohn's disease).
Who may be able to join
- • Adult patients (≥18 years old) diagnosed with inflammatory bowel diseases (ulcerative colitis or Crohn's disease).
- Patients admitted or followed up in Assiut University Hospitals during the study period.
- Patients who have given written informed consent to participate in the study.
Who cannot join
- • Patients with other chronic hematological disorders unrelated to IBD (e.g., aplastic anemia, hemoglobinopathies).
- Patients with concurrent chronic renal failure, liver failure, or other systemic diseases causing anemia.
- Patients receiving recent blood transfusion (within the last 3 months) before enrollment
- Pregnant or lactating women.
- Patients unwilling or unable to complete the study protocol.
About this study
Inflammatory bowel diseases (IBD), encompassing ulcerative colitis (UC) and Crohn's disease (CD), are chronic, relapsing inflammatory disorders of the gastrointestinal tract with significant morbidity and impact on patients' quality of life. Despite advances in diagnostic and therapeutic strategies, many patients continue to experience complications, frequent hospitalizations, and impaired long-term outcomes. Identifying prognostic factors that can predict disease course and response to therapy is therefore crucial in guiding clinical management and optimizing resource utilization.
Anemia is one of the most frequent extraintestinal manifestations of IBD, with prevalence estimates ranging from 20% to 70% depending on disease activity and population studied. The pathogenesis of anemia in IBD is multifactorial, including iron deficiency due to chronic intestinal blood loss, anemia of chronic disease driven by inflammation, vitamin B12 or folate deficiency, and medication-related bone marrow suppression. Anemia has been consistently associated with increased disease activity, reduced health-related quality of life, higher rates of hospitalization, and poorer overall prognosis in IBD patients.
Given its potential as a simple and accessible biomarker, hemoglobin level and anemia status may serve as valuable predictors of disease outcome. However, local data from Egyptian populations, particularly from Assiut University Hospitals, remain scarce. Studying anemia as a prognostic factor in IBD patients may provide insight into disease severity, help stratify patients at higher risk, and support the development of tailored therapeutic and monitoring strategies. This research aims to fill this knowledge gap by evaluating the prognostic significance of anemia in IBD patients managed at Assiut University Hospitals.
- Conditions
- Inflammatory Bowel Diseases
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | Adult patients (≥18 years old) diagnosed with inflammatory bowel diseases (ulcerative colitis or Crohn's disease). |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospitalization rate
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Kotb Abdullah Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387588
- Sponsor's protocol ID
- Anemia IDB
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anemia as Predictor of Outcome in IBD Pateints in Assuit University Hospitals
- ClinicalTrials.gov ID
- NCT07387588
- Acronym / sponsor ID
- Anemia IDB
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Feb 2026 (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.
Inflammatory bowel diseases (IBD), encompassing ulcerative colitis (UC) and Crohn's disease (CD), are chronic, relapsing inflammatory disorders of the gastrointestinal tract with significant morbidity and impact on patients' quality of life. Despite advances in diagnostic and therapeutic strategies, many patients continue to experience complications, frequent hospitalizations, and impaired long-term outcomes. Identifying prognostic factors that can predict disease course and response to therapy is therefore crucial in guiding clinical management and optimizing resource utilization.
Anemia is one of the most frequent extraintestinal manifestations of IBD, with prevalence estimates ranging from 20% to 70% depending on disease activity and population studied. The pathogenesis of anemia in IBD is multifactorial, including iron deficiency due to chronic intestinal blood loss, anemia of chronic disease driven by inflammation, vitamin B12 or folate deficiency, and medication-related bone marrow suppression. Anemia has been consistently associated with increased disease activity, reduced health-related quality of life, higher rates of hospitalization, and poorer overall prognosis in IBD patients.
Given its potential as a simple and accessible biomarker, hemoglobin level and anemia status may serve as valuable predictors of disease outcome. However, local data from Egyptian populations, particularly from Assiut University Hospitals, remain scarce. Studying anemia as a prognostic factor in IBD patients may provide insight into disease severity, help stratify patients at higher risk, and support the development of tailored therapeutic and monitoring strategies. This research aims to fill this knowledge gap by evaluating the prognostic significance of anemia in IBD patients managed at Assiut University Hospitals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –Adult patients (≥18 years old) diagnosed with inflammatory bowel diseases (ulcerative colitis or Crohn's disease). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years old) diagnosed with inflammatory bowel diseases (ulcerative colitis or Crohn's disease).
Key inclusion criteria (3 listed)
- • Adult patients (≥18 years old) diagnosed with inflammatory bowel diseases (ulcerative colitis or Crohn's disease).
Key exclusion criteria (5 listed)
- • Patients with other chronic hematological disorders unrelated to IBD (e.g., aplastic anemia, hemoglobinopathies).
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
hospitalization rate
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, 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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 4 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospitalization rate (time frame: baseline). 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 4 Feb 2026.