Status:
COMPLETED
Treatment With Lactobacillus Rhamnosus and Lactobacillus Acidophilus for Patients With Active Colonic Crohn's Disease.
Lead Sponsor:
Odense University Hospital
Collaborating Sponsors:
University of Southern Denmark
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 diseas...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00374374
Start Date
May 1 2001
End Date
November 1 2005
Last Update
September 11 2006
Active Locations (1)
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1
Dept. of Medical Gastroenterology (afd.S), Odense University Hospital
Odense, Denmark, 5000 C