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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
  Purpose

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 Intervention
Crohn's Disease
Behavioral: Administration of probiotic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Treatment With Lactobacillus Rhamnosus and Lactobacillus Acidophilus for Patients With Active Colonic Crohn’s Disease.

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Decrease in CDAI

Secondary Outcome Measures:
  • Increase in IBDQ

Estimated Enrollment: 30
Study Start Date: May 2001
Estimated Study Completion Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374374

Locations
Denmark
Dept. of Medical Gastroenterology (afd.S), Odense University Hospital
Odense, Denmark, 5000 C
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00374374     History of Changes
Other Study ID Numbers: 19990156
Study First Received: September 7, 2006
Last Updated: September 7, 2006
Health Authority: Denmark: Ethics Committee

Keywords provided by Odense University Hospital:
probiotic

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014