Thalidomide Therapy for VEOIBD

Fudan University

Status: Enrolling

Conditions: Inflammatory Bowel Diseases

Treatments: Drug: Thalidomide

Study type: Observational

Funder types: Other

Identifiers

NCT06382519

Thal in VEOIBD

Details and patient eligibility

About

This is a single center, observational study to investigate the clinical outcomes of thalidomide treatment for very early onset inflammatory bowel disease

Full description

Very early onset inflammatory bowel disease (VEOIBD) refers to IBD diagnosed before 6 years of age. VEOIBD comprises a distinct subset of pediatric IBD characterized by stronger genetic predisposition, predominant colonic involvement, more extensive inflammation, more severe course, and peculiar response to treatments. Previous studies have been demonstrated that thalidomide, an oral molecule with immunomodulatory, antiangiogenic, and TNF-suppressing properties, is an effective and safe treatment for adults and children with IBD refractory to conventional therapies. This study is aimed to evaluate the efficacy and tolerance of thalidomide in VEOIBD.

Enrollment: 40 estimated patients

Sex: All

Ages: 28 days to 6 years old

Volunteers: No Healthy Volunteers

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