Crohn's Disease Clinical Trial
Official title:
Treatment With Lactobacillus Rhamnosus and Lactobacillus Acidophilus for Patients With Active Colonic Crohn’s Disease.
The purpose of this study is to determine whether a probiotic containing Lactobacillus Acidophilus and Lactobacillus Rhamnosus is effective as treatment for patients with active colonic Crohn's disease
The aetiology of Crohn’s disease is still not known. In the recent years there has been an
increasing interest in the relationship between the gastrointestinal flora and gut function.
Several studies have shown promising results for the use of probiotics in patient with
inflammatory bowel disease.
Aim: The aim of the current study is to evaluate the effect of a probiotic suspension in
patients with active colonic Crohn’s disease.
Methods: The study is a two-centre, randomised placebo-controlled, and double-blind trial.
Patients above the age of 18 years, attending our out-patient clinic, can be included if
they have Crohn’s disease in the colon or colon and small bowel and have active disease with
a CDAI: 220-400. Patients are not included if they have undergone larger bowel resections,
have been treated with antibiotics within the last two months, if dose of prednisolone has
been changed within the last 4 weeks, or dose of immunosuppressives has been changed within
the last 2 months. During the study period no changes in medication is allowed. During an 8
week period patients are treated with a combination of lactobacillus rhamnosus strain
19070-2 and lactobacillus acidophilus strain 18911-2 (10EE9 colony forming unit/ml).
Freeze-dried probiotics are dissolved in sterile water to a volume of 1 ml which is ingested
once daily, in the evening.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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