- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00374374
Treatment With Lactobacillus Rhamnosus and Lactobacillus Acidophilus for Patients With Active Colonic Crohn's Disease.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Odense, Denmark, 5000 C
- Dept. of Medical Gastroenterology (afd.S), Odense University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Decrease in CDAI
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Secondary Outcome Measures
Outcome Measure |
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Increase in IBDQ
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jens Kjeldsen, MD, PhD, Odense University Hospital
- Principal Investigator: Lone G Klinge, Odense University Hospital
- Study Chair: Karsten Lauritsen, Odense University Hospital
- Principal Investigator: Ole Oestergaard-Thomsen, Herlev Hospital
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19990156
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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