Treatment With Lactobacillus Rhamnosus and Lactobacillus Acidophilus for Patients With Active Colonic Crohn’s Disease.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Treatment With Lactobacillus Rhamnosus and Lactobacillus Acidophilus for Patients With Active Colonic Crohn’s Disease.|
- Decrease in CDAI
- Increase in IBDQ
|Study Start Date:||May 2001|
|Estimated Study Completion Date:||November 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374374
|Dept. of Medical Gastroenterology (afd.S), Odense University Hospital|
|Odense, Denmark, 5000 C|
|Principal Investigator:||Lone G Klinge||Odense University Hospital|
|Principal Investigator:||Jens Kjeldsen, MD, PhD||Odense University Hospital|
|Study Chair:||Karsten Lauritsen||Odense University Hospital|
|Principal Investigator:||Ole Oestergaard-Thomsen||Herlev Hospital|