Oral immunoglobulin - a novel treatment of children with Crohn´s disease - Oral immunoglobuli

• Conditions: Children with the chronic inflammatory bowel Crohn´s disease in an active phase

• Registration Number: EUCTR2004-005016-93-SE
• Lead Sponsor: Vrinnevi Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

? Age < 18 years.
? A diagnosis of CD according to current diagnostic criteria. The patient can be newly diagnosed or have a previously diagnosed CD.
? Active disease with a PCDAI-index > 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

? 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.