NCT00268164

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2004

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

May 6, 2015

Status Verified

September 1, 2006

Enrollment Period

2.7 years

First QC Date

December 21, 2005

Last Update Submit

May 5, 2015

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Number of patients with relapse at 12 month.

Secondary Outcomes (3)

  • Number of days to relapse.

  • Presence and concentrations of the probiotic bacterial strains in stool.

  • Safety and tolerance of the probiotic mixture.

Interventions

lactobacilus acidophilus & bifidobacterium animalis/lactisDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Medical Gastroenterology

Hvidovre, Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 21453880DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Flemming Bendtsen, MD, DMSci

    Dept. of Medical Gastroenterology, Hvidovre University Hospital, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 22, 2005

Study Start

June 1, 2004

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

May 6, 2015

Record last verified: 2006-09

Locations

DK(1)