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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00268164
• Other study ID #: AB coul
• Status: Terminated
• Phase: Phase 2
• First received: December 21, 2005
• Last updated: May 5, 2015
• Start date: June 2004
• Est. completion date: March 2007

Study information

• Verified date: September 2006
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• lactobacilus acidophilus & bifidobacterium animalis/lactis

Locations

Country	Name	City	State
Denmark	Dept. of Medical Gastroenterology	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Chr Hansen A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with relapse at 12 month.
Secondary	Number of days to relapse.
Secondary	Presence and concentrations of the probiotic bacterial strains in stool.
Secondary	Safety and tolerance of the probiotic mixture.