Thalidomide treatment for very early onset inflammatory bowel disease
Official title: Thalidomide Therapy for Very Early Onset Inflammatory Bowel Disease
Run by Children's Hospital of Fudan University · NCT06382519 · Data updated 2026-11-12
This study is testing if thalidomide can help young children with very early onset inflammatory bowel disease feel better and stay safe while using the medication.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 28 Days to 6 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | May 15, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | May 22, 2025 |
| Trial ID | NCT06382519 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children diagnosed with inflammatory bowel disease before the age of 6 who have moderate to severe disease activity.
✕Probably not a fit
Patients with liver dysfunction, allergies to thalidomide, or those who have received certain treatments recently may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the clinical outcomes of thalidomide treatment in children diagnosed with very early onset inflammatory bowel disease (VEOIBD), which occurs before the age of 6. VEOIBD is characterized by a strong genetic predisposition and more severe disease course compared to typical IBD. The study aims to evaluate the efficacy and safety of thalidomide, an oral medication known for its immunomodulatory and anti-inflammatory properties, in this specific pediatric population. Participants will be monitored for their response to treatment and any potential side effects.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for managing very early onset inflammatory bowel disease in children.
How similar studies have gone: Previous studies have shown thalidomide to be effective in treating IBD in adults and older children, suggesting potential success in this novel pediatric application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosed with inflammatory bowel disease * disease onset less than 6 years old * Pediatric Crohn's disease Activity Index (PCDAI)\>30 or Pediatric Ulcerative Colitis Activity Index (PUCAI)\>35 * patients and their legal guardians were willing to receive thalidomide treatment and participate in this study. Exclusion Criteria: * liver dysfunction * allergy to thalidomide * with Neuropathy * with thrombosis * thalidomide treatment in the previous 30 days * biologics treatment in the previous 8 weeks * not suitable participated in this study
Where it's running
-
Lin Wang
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Principal investigator: Ying Huang — Children's Hospital of Fudan University
- Study coordinator: Ying Huang
- Email: yhuang815@163.com
- Phone: 021-64931727
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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.