Ulcerative ColitisNCT00374725
Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus.
A study testing Administration of probiotic (L. rhamnosus and L. acidophilus) in people with Ulcerative Colitis, run by Odense University Hospital at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Administration of probiotic (L. rhamnosus and L. acidophilus)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 130 participants
- Where
- 2 sitesDenmark
- Study dates
- Feb 2003to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with known ulcerative colitis
- At least one prior flare of the disease
- Clinically and endoscopically active disease
- Age: 18 and above
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital
Aarhus
Dept. of Medical Gastroenterology (afd.S), Odense University Hospital
Odense, 5000 C
About this study
Official title: Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus. A Randomised Placebo Controlled Trial
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.
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Administration of probiotic (L. rhamnosus and L. acidophilus)
- Keywords
- Ulcerative Colitis, Probiotic, Placebo controlled trial, Lactobacillus rhamnosus, Lactobacillus acidophilus
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of probiotic (L. rhamnosus and L. acidophilus)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2006 (estimated)
- Study startFeb 2003
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 130 participants
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Crohn's and Colitis Foundation
- Investigators
- Lone G Klinge, MD, Principal investigator, Odense University HospitalJens Kjeldsen, MD, PhD, Principal investigator, Odense University HospitalKarsten Lauritsen, MD, Dr.med., Study chair, Odense University HospitalLisbeth Ambrosius, MD,Dr.med., Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374725
- Sponsor's protocol ID
- VF 20020197
- Status last verified
- Nov 2002
- First submitted
- 7 Sep 2006
- Last updated
- 11 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus. A Randomised Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00374725
- Acronym / sponsor ID
- VF 20020197
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis, Probiotic, Placebo controlled trial, Lactobacillus rhamnosus, Lactobacillus acidophilus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Crohn's and Colitis Foundation
- Study start
- Feb 2003
- Study completion
- May 2006
- First posted
- 11 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with known ulcerative colitis
- At least one prior flare of the disease
- Clinically and endoscopically active disease
- Age: 18 and above
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of probiotic (L. rhamnosus and L. acidophilus) | Behavioural | – |
Primary outcome
Number of patients in remission in the two groups at the end of the treatment period
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lone G Klinge, MD principal investigator
Odense University Hospital
Jens Kjeldsen, MD, PhD principal investigator
Odense University Hospital
Karsten Lauritsen, MD, Dr.med. study chair
Odense University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of probiotic (L. rhamnosus and L. acidophilus) in people with Ulcerative Colitis, run by Odense University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients in remission in the two groups at the end of the treatment period. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2006.