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

Phase 2TerminatedNCT00268164

Hvidovre University Hospital48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Ulcerative Colitis

Interventions

lactobacilus acidophilus & bifidobacterium animalis/lactisDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Dept. of Medical Gastroenterology

Hvidovre, Hvidovre, Denmark

Outcomes

Primary Outcomes

Number of patients with relapse at 12 month.

Secondary Outcomes

Number of days to relapse.

Presence and concentrations of the probiotic bacterial strains in stool.

Safety and tolerance of the probiotic mixture.

Data from ClinicalTrials.gov

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