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

Primary Purpose

Ulcerative Colitis

Status
Terminated
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
lactobacilus acidophilus & bifidobacterium animalis/lactis
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Medical Gastroenterology

Outcomes

Primary Outcome Measures

Number of patients with relapse at 12 month.

Secondary Outcome Measures

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

Full Information

First Posted
December 21, 2005
Last Updated
May 5, 2015
Sponsor
Hvidovre University Hospital
Collaborators
Chr Hansen
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1. Study Identification

Unique Protocol Identification Number
NCT00268164
Brief Title
Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis
Official Title
Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Terminated
Why Stopped
Inclusion was difficult and to slow
Study Start Date
June 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hvidovre University Hospital
Collaborators
Chr Hansen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
48 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
lactobacilus acidophilus & bifidobacterium animalis/lactis
Primary Outcome Measure Information:
Title
Number of patients with relapse at 12 month.
Secondary Outcome Measure Information:
Title
Number of days to relapse.
Title
Presence and concentrations of the probiotic bacterial strains in stool.
Title
Safety and tolerance of the probiotic mixture.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flemming Bendtsen, MD, DMSci
Organizational Affiliation
Dept. of Medical Gastroenterology, Hvidovre University Hospital, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Dept. of Medical Gastroenterology
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
21453880
Citation
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. Erratum In: J Crohns Colitis. 2022 Aug 16;:
Results Reference
derived

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

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