NCT00374725

Brief Summary

In this trial we test the hypothesis that a probiotic containing Lactobacillus acidophilus and Lactobacillus rhamnosus is an effective therapy for patients with ulcerative colitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
Last Updated

September 11, 2006

Status Verified

November 1, 2002

First QC Date

September 7, 2006

Last Update Submit

September 8, 2006

Conditions

Ulcerative Colitis

Keywords

Ulcerative ColitisProbioticPlacebo controlled trialLactobacillus rhamnosusLactobacillus acidophilus

Outcome Measures

Primary Outcomes (1)

  • Number of patients in remission in the two groups at the end of the treatment period

Secondary Outcomes (4)

  • Difference in time to relapse in the two treatment groups

  • Number of patients successfully obtaining remission

  • Time to remission in the two groups

  • Time ro relapse after study treatment is discontinued

Interventions

Administration of probiotic (L. rhamnosus and L. acidophilus)BEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • Patients with known ulcerative colitis
  • At least one prior flare of the disease
  • Clinically and endoscopically active disease
  • Age: 18 and above

You may not qualify if:

  • Changes in azathioprine dosage within the last three months
  • Patients with toxic megacolon, peritoneal reaction or severe colonic bleeding
  • Known immunodeficiencies
  • On-going infectious disease
  • On-going treatment with NSAID or cholestyramine
  • Pregnant og lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University Hospital

Aarhus, Denmark

Location

Dept. of Medical Gastroenterology (afd.S), Odense University Hospital

Odense, 5000 C, Denmark

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Lone G Klinge, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

  • Jens Kjeldsen, MD, PhD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

  • Karsten Lauritsen, MD, Dr.med.

    Odense University Hospital

    STUDY CHAIR

  • Lisbeth Ambrosius, MD,Dr.med.

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2006

First Posted

September 11, 2006

Study Start

February 1, 2003

Study Completion

May 1, 2006

Last Updated

September 11, 2006

Record last verified: 2002-11

Locations

DK(2)