Children with the chronic inflammatory bowel Crohn´s disease in an active phase
Conditions
Interventions
Trade Name: Polyglobin 10%
Product Name: Polyglobin 10%
Pharmaceutical Form: Intravenous infusion
Sponsors
Vrinnevi Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Age 10 ? Medication with 5-ASA-drugs, corticosteroids or azathioprin is accepted if ongoing for at least 2 months immediately prior to entry of the study. ? Treatment with partial or exclusive enteral nutrition is accepted. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Patients, who are expected to be unable to fulfil the treatment protocol or come to hospital visits agreed upon. ? Patients with selective IgA deficiency. ? Patients, who due to their CD are in immediate need for an operation or are expected to need an operation within 2 months from entry of the study. ? Patients with stoma. ? Ongoing antibiotic treatment (sulphasalazine not included). ? Signs of ongoing gastrointestinal infection. ? Immediate need for total parenteral nutrition. ? Immediate need for increasing the medication (5-ASA preparations, corticosteroids, azathioprin).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the efficacy of oral immunoglobulin treatment of children with active Crohn´s disease.;Secondary Objective: To assess the tolerability of oral immunoglobulin treatment of children with active Crohn´s disease.;Primary end point(s): The efficacy of oral immunoglobulin as treatment of children with active Crohn´s disease. | — |
Countries
Sweden
Outcome results
None listed