Cholera, Inflammatory Bowel Diseases
Conditions
Brief summary
Assessment of the immunogenicity and safety of immunization against cholera in children with inflammatory bowel disease.
Interventions
BIOLOGICALVaccination against cholera
Participants will receive two doses of an oral cholera vaccine with an interval of 2-4 weeks.
Sponsors
Medical University of Gdansk
Medical University of Warsaw
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achieving seroprotective antibody concentration | 4-6 weeks after the second dose | Serum antibody concentration indicating protection against cholera. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects | 3 days after each dose | Evaluation of adverse effects after vaccination. |
| 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. |
Countries
Poland
Outcome results
None listed