Immunogenicity of Cholera Vaccine in Children With IBD
Not Applicable
Completed
- Conditions
- Inflammatory Bowel DiseasesCholera
- Registration Number
- NCT03998449
- Lead Sponsor
- Medical University of Warsaw
- Brief Summary
Assessment of the immunogenicity and safety of immunization against cholera in children with inflammatory bowel disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- diagnosis of Crohn's disease or ulcerative colitis based on standard clinical, endoscopic, histologic and radiographic criteria (Porto criteria),
- no vaccination against cholera in the past,
- written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age.
Exclusion Criteria
- serious exacerbation of inflammatory bowel disease defined as Paediatric Ulcerative Colitis Activity Index (PUCAI) > 65 points for patients with ulcerative colitis or Pediatric Crohn's Disease Activity Index (PCDAI) > 40 points for patients with Crohn's disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Achieving seroprotective antibody concentration 4-6 weeks after the second dose Serum antibody concentration indicating protection against cholera.
- Secondary Outcome Measures
Name Time Method Inflammatory bowel disease exacerbation occurrence. 4-6 weeks after the second dose Disease exacerbation assessed according to the Paediatric Ulcerative Colitis Activity Index (PUCAI) for patients with ulcerative colitis or Pediatric Crohn's Disease Activity Index (PCDAI) for patients with Crohn's disease.
Adverse effects 3 days after each dose Evaluation of adverse effects after vaccination.
Trial Locations
- Locations (1)
Medical University of Warsaw
🇵🇱Warsaw, Poland
Medical University of Warsaw🇵🇱Warsaw, Poland