Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00268164
NCT00268164TerminatedPhase 2

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

Hvidovre University Hospital1 site in 1 country48 target enrollmentStarted: June 1, 2004Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Enrollment
48
Locations
1
Primary Endpoint
Number of patients with relapse at 12 month.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Number of patients with relapse at 12 month.

Secondary Outcomes

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

Investigators

Sponsor Class
Other

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Treatment With Lactobacillus Rhamnosus and Lactobacillus Acidophilus for Patients With Active Colonic Crohn's Disease.Crohn's Disease
NCT00374374Odense University Hospital30
Completed
Phase 2
Efficacy of Probiotics in the Gut Microbiota and H Pylori DensityHelicobacter
NCT02725138Statistical Center, NTUHCTC40
Completed
Not Applicable
Effects of Lactic Acid Bacteria and Bifidobacterium-containing Supplements on Intestinal FloraHealthy adult
JPRN-UMIN000036843Japan clinical trial assosiation21
Withdrawn
Not Applicable
Evaluation of Two Active Lactobacilli for the Maintenance of Gingival HealthGingivitis
NCT03291327Queen Mary University of London
Active, not recruiting
Not Applicable
The effect of Lactobacillus acidophilus eBifidobacterium lactis on hepatic steatosis and difficulty in insulin action in obese adolescents: A randomized clinical trialPediatric ObesityObesity due to excess caloriesFatty (change of) liver, not elsewhere classifiedOther specified endocrine disordersC18.654.726.500.720E66.0C06.552.241K76.0C18.452.394.968.500E34.8Fatty LiverInsulin Resistance
RBR-9n7kfwEscola Bahiana de Medicina e Saúde Pública