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

Vrinnevi Hospital0 个研究点目标入组 15 人开始时间: 2004年12月13日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•? 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

•? 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).

发起方

Vrinnevi Hospital