Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis

Phase 2

Terminated

• Conditions: Ulcerative Colitis

• Registration Number: NCT00268164
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

The purpose of this study is to determine whether the lactic acid bacteria " Lactobacillus acidophilus (LA5) and Bifidobacterium animalis subsp. lactis (BB12)" is effective as maintenance treatment in ulcerative colitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-12-21
• Study First Submitted QC: 2005-12-21
• Study First Posted: 2005-12-22
• Status Verified: 2006-09
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Last Update Submitted: 2015-05-05
• Last Update Posted: 2015-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Patients with ulerative colitis ording to well-known diagnostic criteria and remission for at least one month, and with at least one relapse within the last year.

Exclusion Criteria

• Pregnancy and lactating
• Serious underlying disease other than UC
• Former gastrointestinal resections
• Medication for UC other than mesalazine
• Known allergic reactions towards compounds in the study drug.
• Expected lack of compliance due to mental state or language problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of patients with relapse at 12 month.

Secondary Outcome Measures

Name	Time	Method
Number of days to relapse.
Presence and concentrations of the probiotic bacterial strains in stool.
Safety and tolerance of the probiotic mixture.

Trial Locations

Locations (1)

Dept. of Medical Gastroenterology; 🇩🇰 Hvidovre, Denmark