Iron treatment for children and young adults with Crohn’s disease and iron deficiency anemia
Official title: 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
Run by Weill Medical College of Cornell University · NCT07925450 · Data updated 2026-11-12
This study tests how different iron treatment approaches work for kids and young adults with Crohn’s disease and iron deficiency anemia.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 3 Years to 21 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | September 13, 2023 |
| Main results expected | March 13, 2029 |
| Study ends | June 30, 2029 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07925450 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Male or female patients aged 3–21 with biopsy-confirmed Crohn’s disease involving the upper small intestine and iron deficiency anemia, with quiescent disease.
✕Probably not a fit
Patients with active Crohn’s disease or iron deficiency not responsive to standard iron therapy may see limited benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional phase 4 study will develop and test a model to identify which iron treatment approach best helps patients with Crohn’s disease and iron deficiency anemia. Researchers will analyze lab values, disease activity, treatment data, and gut bacteria information, then follow participants over time and collect questionnaires on iron supplement use and related symptoms. The goal is to guide iron therapy decisions for pediatric and young adult patients. Enrollment focuses on those with Crohn’s affecting gastric, duodenal, or jejunal mucosa and confirmed iron deficiency anemia with stable disease activity. Exclusion criteria include recent antibiotic use within six weeks of an endoscopic evaluation.
Why it matters
Potential benefit: If successful, the model could help clinicians choose more effective iron therapies for children and young adults with Crohn’s disease and iron deficiency anemia.
How similar studies have gone: Previous studies have explored iron supplementation in Crohn’s, but this approach aims to optimize treatment choice using a predictive model.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * antibiotic use with 6 weeks of endoscopic evaluation
Where it's running
-
Weill Cornell Medicine
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Robbyn E Sockolow, MD — Weill Medical College of Cornell University
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.