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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374374
• Other study ID #: 19990156
• Status: Completed
• Phase: N/A
• First received: September 7, 2006
• Last updated: September 7, 2006
• Start date: May 2001
• Est. completion date: November 2005

Study information

• Verified date: April 2006
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Behavioral:
• Administration of probiotic

Locations

Country	Name	City	State
Denmark	Dept. of Medical Gastroenterology (afd.S), Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in CDAI
Secondary	Increase in IBDQ