NCT00374374

Brief Summary

The purpose of this study is to determine whether a probiotic containing Lactobacillus Acidophilus and Lactobacillus Rhamnosus is effective as treatment for patients with active colonic Crohn's disease

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2001

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
10 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

April 1, 2006

First QC Date

September 7, 2006

Last Update Submit

September 7, 2006

Conditions

Crohn's Disease

Keywords

probiotic

Outcome Measures

Primary Outcomes (1)

  • Decrease in CDAI

Secondary Outcomes (1)

  • Increase in IBDQ

Interventions

Administration of probioticBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • Previously diagnosed Crohn's disease of the large bowel or large and small bowel according to established criteria.
  • At least one prior episode of active disease
  • Stoolcultures and microscopies without pathogenic bacteria or parasites
  • CDAI 220-400
  • Informed consent

You may not qualify if:

  • More than 15mg of prednisolone daily (or equivalent)
  • Symptoms of Crohn's disease assumed to be caused by mechanical obstruction og abscesses
  • Long term treatment with NSAID or colestyramine
  • Pregnant and lactating women
  • Bowel resections removing more than 100 centimetres of small intestine or any colonic resection other than ileo-cecal resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Odense, 5000 C, Denmark

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Lone G Klinge

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

  • Jens Kjeldsen, MD, PhD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

  • Karsten Lauritsen

    Odense University Hospital

    STUDY CHAIR

  • Ole Oestergaard-Thomsen

    Herlev 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

May 1, 2001

Study Completion

November 1, 2005

Last Updated

September 11, 2006

Record last verified: 2006-04

Locations

DK(1)