Crohn's DiseaseNCT00374374
Treatment With Lactobacillus Rhamnosus and Lactobacillus Acidophilus for Patients With Active Colonic Crohn's Disease.
A study testing Administration of probiotic in people with Crohn's Disease, run by Odense University Hospital at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Administration of probiotic
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- May 2001to Nov 2005
- 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
- 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
Who cannot join
- More than 15mg of prednisolone daily (or equivalent)
- Changes in dosage of glucocorticoids during the last four weeks prior to inclusion
- Changes in dosage of Azathioprine during the last 3 months prior to inclusion
- Antibiotic treatment during the last two months prior to inclusion
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Medical Gastroenterology (afd.S), Odense University Hospital
Odense, 5000 C
About this study
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
Read the detailed description
The aetiology of Crohn's disease is still not known. 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.
Aim: The aim of the current study is to evaluate the effect of a probiotic suspension in patients with active colonic Crohn's disease.
Methods: The study is a two-centre, randomised placebo-controlled, and double-blind trial. Patients above the age of 18 years, attending our out-patient clinic, can be included if they have Crohn's disease in the colon or colon and small bowel and have active disease with a CDAI: 220-400. Patients are not included if they have undergone larger bowel resections, have been treated with antibiotics within the last two months, if dose of prednisolone has been changed within the last 4 weeks, or dose of immunosuppressives has been changed within the last 2 months. During the study period no changes in medication is allowed. During an 8 week period patients are treated with a combination of lactobacillus rhamnosus strain 19070-2 and lactobacillus acidophilus strain 18911-2 (10EE9 colony forming unit/ml). Freeze-dried probiotics are dissolved in sterile water to a volume of 1 ml which is ingested once daily, in the evening.
- Conditions
- Crohn's Disease
- Being tested
- Administration of probiotic
- Keywords
- probiotic
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of probioticBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in CDAI
Secondary outcomes (1)
Increase in IBDQ
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 startMay 2001
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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
- 30 participants
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Investigators
- Lone G Klinge, Principal investigator, Odense University HospitalJens Kjeldsen, MD, PhD, Principal investigator, Odense University HospitalKarsten Lauritsen, Study chair, Odense University HospitalOle Oestergaard-Thomsen, Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374374
- Sponsor's protocol ID
- 19990156
- Status last verified
- Apr 2006
- 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 With Lactobacillus Rhamnosus and Lactobacillus Acidophilus for Patients With Active Colonic Crohn's Disease.
- ClinicalTrials.gov ID
- NCT00374374
- Acronym / sponsor ID
- 19990156
- Conditions
- Crohn's Disease
- Keywords
- probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- May 2001
- Study completion
- Nov 2005
- 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.
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
Detailed description
The aetiology of Crohn's disease is still not known. 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.
Aim: The aim of the current study is to evaluate the effect of a probiotic suspension in patients with active colonic Crohn's disease.
Methods: The study is a two-centre, randomised placebo-controlled, and double-blind trial. Patients above the age of 18 years, attending our out-patient clinic, can be included if they have Crohn's disease in the colon or colon and small bowel and have active disease with a CDAI: 220-400. Patients are not included if they have undergone larger bowel resections, have been treated with antibiotics within the last two months, if dose of prednisolone has been changed within the last 4 weeks, or dose of immunosuppressives has been changed within the last 2 months. During the study period no changes in medication is allowed. During an 8 week period patients are treated with a combination of lactobacillus rhamnosus strain 19070-2 and lactobacillus acidophilus strain 18911-2 (10EE9 colony forming unit/ml). Freeze-dried probiotics are dissolved in sterile water to a volume of 1 ml which is ingested once daily, in the evening.
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 (5 listed)
- 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
Key exclusion criteria (8 listed)
- More than 15mg of prednisolone daily (or equivalent)
- Changes in dosage of glucocorticoids during the last four weeks prior to inclusion
- Changes in dosage of Azathioprine during the last 3 months prior to inclusion
- Antibiotic treatment during the last two months prior to inclusion
- Symptoms of Crohn's disease assumed to be caused by mechanical obstruction og abscesses
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 | Behavioural | – |
Primary outcome
Decrease in CDAI
1 secondary outcome
Increase in IBDQ
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 principal investigator
Odense University Hospital
Jens Kjeldsen, MD, PhD principal investigator
Odense University Hospital
Karsten Lauritsen study chair
Odense University Hospital
1 site 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 in people with Crohn's Disease, run by Odense University Hospital at 1 site 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 5 inclusion and 8 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 1 site 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?
Decrease in CDAI. 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.