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

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.

Timeline

Start

2004-06

Primary completion

2007-03

Completion

2007-03

Outcome

Missed primary endpoint

Stopped: “Inclusion was difficult and to slow”

paper Five patients (25%) in the Probio-Tec AB-25 group and one patient (8%) in the placebo group maintained remission after 1 year of treatment (p=0.37). PMID 21453880 ↗

paper no significant clinical benefit of Probio-Tec AB-25 could be demonstrated in comparison with placebo for maintaining remission PMID 21453880 ↗

Publications

• Wildt S, Nordgaard I, Hansen U, Brockmann E, Rumessen JJ. A randomised double-blind placebo-controlled trial with Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp. lactis BB-12 for maintenance of remission in ulcerative colitis. J Crohns Colitis. 2011 Apr;5(2):115-21. doi: 10.1016/j.crohns.2010.11.004. Epub 2011 Jan 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bifidobacterium animalis subsp. lactis	Other / unclassified	—	—
Subject	Lactobacillus acidophilus	Other / unclassified	—	—

Indications