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

This study has been completed.
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00374374
First received: September 7, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted

September 7, 2006
September 7, 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00374374
19990156
Not Provided
Not Provided
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