NCT07387588

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

January 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 28, 2026

Last Update Submit

January 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • hospitalization rate

    baseline

Study Arms (1)

study group

Adult patients (≥18 years old) diagnosed with inflammatory bowel diseases (ulcerative colitis or Crohn's disease).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients (≥18 years old) diagnosed with inflammatory bowel diseases (ulcerative colitis or Crohn's disease).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
residant doctor at Assiut university hospital

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 4, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 4, 2026

Record last verified: 2026-01