NCT07925450RecruitingPhase 4
Iron Treatment for Iron Deficiency Anemia in Children and Young Adults With Crohn's Disease
Developing and Validating a Predictive Model for the Management of Iron Deficiency Anemia in Pediatric Crohn's Disease Through Analysis of Microbiome and Patient Laboratory Data
Source: ClinicalTrials.gov · Last updated 9 Nov 2026
Brief summary (registry, in English)
Children and young adults with Crohn's disease may develop iron deficiency anemia, a condition in which low iron levels reduce the number of healthy red blood cells. This study aims to develop and test a model to help identify which iron treatment approached are most effective for these patients. Researchers will examine laboratory results, disease activity, treatment information, and information about bacteria in the digestive tract. Participants will be followed over time, and questionnaires will assess iron supplement use and related symptoms. The findings may help guide iron treatment for children and young adults with Crohn's disease.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 3 Nov 2026
- Start date
- 13 Sept 2023
- Primary completion date
- 13 Mar 2029
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- Crohn's disease
- NCT number
- NCT07925450
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 150
- From 13 Sept 2023 to the primary completion date, 13 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and young adults with Crohn's disease that is currently quiet and who also have low iron in the blood (iron deficiency anemia).
- Age
- 3 to 21 years
- Sex
- Male or female
- Disease stage
- Crohn's disease confirmed by biopsy in the stomach, duodenum and/or jejunum lining. The disease must be quiet (quiescent), judged by biopsy findings, CRP, ESR and PCDAI scores. Iron deficiency anemia: hemoglobin or transferrin saturation below age-defined norms and/or MCV <80.
- Earlier treatment
- No antibiotic use within 6 weeks of the endoscopic evaluation.
- Biomarker or test result
- Hemoglobin or transferrin saturation below age-defined norms and/or MCV <80.
Main reasons for not taking part
- Antibiotic use within 6 weeks of the endoscopic evaluation
Read by machine on 10 Nov 2026.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- antibiotic use with 6 weeks of endoscopic evaluation
Who the study is looking for
- Male or female
- 3 to 21 years of age
- Biopsy confirmed Crohns disease involving gastric, duodenal, and/or jejunal mucosa
- Quiescent Crohns disease, assessed by histopathology, CRP, ESR, and PCDAI scores
- Iron deficiency anemia, defined as hemoglobin or transferrin saturation below age-defined norms and/or MCV <80.
Age in the registry: 3 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Weill Cornell Medicine | New York | United States | Recruiting |
The registry text, word for word
This page is information, not medical advice. Discuss any trial with your doctor.