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

NCT ID: NCT00268164

Last Updated: 2015-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-03-31

Brief Summary

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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

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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lactobacilus acidophilus & bifidobacterium animalis/lactis

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chr Hansen

INDUSTRY

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Flemming Bendtsen, MD, DMSci

Role: STUDY_CHAIR

Dept. of Medical Gastroenterology, Hvidovre University Hospital, Denmark

Locations

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Dept. of Medical Gastroenterology

Hvidovre, Hvidovre, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 21453880 (View on PubMed)

Other Identifiers

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AB coul

Identifier Type: -

Identifier Source: org_study_id

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