Thalidomide Therapy for VEOIBD
Observational · No treatment assigned · 1 site · Children's Hospital of Fudan University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 28 Days to 6
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 1 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2024-05-15.
- Main results expected around 2025-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- endoscopic response rate (week 52)
In the researchers’ words
This is a single center, observational study to investigate the clinical outcomes of thalidomide treatment for very early onset inflammatory bowel disease
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Diseases |
| Lead sponsor | Children's Hospital of Fudan University |
| Enrollment | 40 (estimated) |
| Start date | 2024-05-15 |
| Primary completion (est.) | 2025-12-31 |
| First posted | 2024-04-24 |
| Last updated | 2025-05-22 |
| Official title | Thalidomide Therapy for Very Early Onset Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT06382519 |
Interventions
- Thalidomide (Drug)
thalidomide, dose 1.5-2.5mg/kg.d, orally taken before bedtime.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Lin Wang | Shanghai, Shanghai Municipality | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.