Treatment With Lactobacillus Rhamnosus and Lactobacillus Acidophilus for Patients With Active Colonic Crohn’s Disease.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00374374
Recruitment Status : Completed
First Posted : September 11, 2006
Last Update Posted : September 11, 2006
University of Southern Denmark
Information provided by:
Odense University Hospital

September 7, 2006
September 11, 2006
September 11, 2006
May 2001
Not Provided
Decrease in CDAI
Same as current
No Changes Posted
Increase in IBDQ
Same as current
Not Provided
Not Provided
Treatment With Lactobacillus Rhamnosus and Lactobacillus Acidophilus for Patients With Active Colonic Crohn’s Disease.
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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Crohn's Disease
Behavioral: Administration of probiotic
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2005
Not Provided

Inclusion Criteria:

  • Previously diagnosed Crohn’s disease of the large bowel or large and small bowel according to established criteria.
  • At least one prior episode of active disease
  • Stoolcultures and microscopies without pathogenic bacteria or parasites
  • CDAI 220-400
  • Informed consent

Exclusion Criteria:

  • More than 15mg of prednisolone daily (or equivalent)
  • Changes in dosage of glucocorticoids during the last four weeks prior to inclusion
  • Changes in dosage of Azathioprine during the last 3 months prior to inclusion
  • Antibiotic treatment during the last two months prior to inclusion
  • Symptoms of Crohn's disease assumed to be caused by mechanical obstruction og abscesses
  • Long term treatment with NSAID or colestyramine
  • Pregnant and lactating women
  • Bowel resections removing more than 100 centimetres of small intestine or any colonic resection other than ileo-cecal resection
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
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Odense University Hospital
University of Southern Denmark
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
Odense University Hospital
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP