Treatment of Ulcerative Colitis With a Combination of Lac... | NCT00374725

Studies
Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus.

NCT00374725

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

Sep 11, 2006Estimated

Enrollment

130

Phase

Not Applicable

Conditions

Ulcerative Colitis

Interventions

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

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2002

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2003

Primary Completion Date

Not provided

Completion Date

May 2006

First Submitted Date

Sep 7, 2006

First Submission Date that Met QC Criteria

Sep 8, 2006

First Posted Date

Sep 11, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2006

Last Update Posted Date

Sep 11, 2006Estimated

Name	Class
University of Southern Denmark	OTHER
Crohn's and Colitis Foundation	OTHER

Description Module

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.

Detailed Description

In the recent years there has been an increasing interest in the relationship between the gastrointestinal flora and gut function. Several studies have shown promising results for the use of probiotics in patient with inflammatory bowel disease.

In this trial approximately 100 patients with ulcerative colitis will receive treatment with probiotic or placebo for 8 to 10 months as adjuvant therapy.

The trial is double-blind, randomised and controlled.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130

Name	Type	Description	Arm Group Labels	Other Names
Administration of probiotic (L. rhamnosus and L. acidophilus)	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients in remission in the two groups at the end of the treatment period

Secondary Outcomes

Measure	Description	Time Frame
Difference in time to relapse in the two treatment groups
Number of patients successfully obtaining remission
Time to remission in the two groups

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital		Aarhus			Denmark
Dept. of Medical Gastroenterology (afd.S), Odense University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided