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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

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Crohn's Disease Behavioral: Administration of probiotic Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Treatment With Lactobacillus Rhamnosus and Lactobacillus Acidophilus for Patients With Active Colonic Crohn's Disease.
Study Start Date : May 2001
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Primary Outcome Measures :
  1. Decrease in CDAI

Secondary Outcome Measures :
  1. Increase in IBDQ

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00374374

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Dept. of Medical Gastroenterology (afd.S), Odense University Hospital
Odense, Denmark, 5000 C
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
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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
Layout table for additonal information Identifier: NCT00374374    
Other Study ID Numbers: 19990156
First Posted: September 11, 2006    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: April 2006
Keywords provided by Odense University Hospital:
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases