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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00114465




Registration number
NCT00114465
Ethics application status
Date submitted
14/06/2005
Date registered
15/06/2005
Date last updated
18/09/2009

Titles & IDs
Public title
VSL#3 Versus Placebo in Maintenance of Remission in Crohn's Disease
Scientific title
Randomized, Double-Blind, Placebo-Controlled Study of VSL#3 Versus Placebo in the Maintenance of Remission in Crohn's Disease
Secondary ID [1] 0 0
VSL#3Freo
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - VSL#3
Other interventions - Placebo

Experimental: VSL#3 - Probiotic

Placebo comparator: Placebo - Placebo


Treatment: Drugs: VSL#3
VSL#3 1 sachet twice a day

Other interventions: Placebo
Placebo 1 sachel twice a day
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary objective of the study is to compare the efficacy of the probiotic VSL#3 versus placebo, in addition to standard maintenance drugs, in maintaining remission in Crohn's disease (CD)
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Time till flare of CD
Timepoint [1] 0 0
within 1 year of commencing therapy
Secondary outcome [2] 0 0
To assess whether concurrent therapy with VSL#3 leads to an improvement in the quality of life
Timepoint [2] 0 0
within 1 year of commencing therapy
Secondary outcome [3] 0 0
To assess whether concurrent therapy with VSL#3 reduces the severity of a flare if it occurs
Timepoint [3] 0 0
within 1 year of commencing therapy

Eligibility
Key inclusion criteria
* Subjects should have a definitive diagnosis of colonic CD or small bowel and colonic CD based on clinical, radiological, endoscopic and pathological findings.
* Subjects should have a CDAI score <150 at week 0
* Patients receiving the following treatment are eligible:

5 aminosalicylates, if the dose remained constant for 4 weeks before the screening visit and had been used continuously for 8 weeks before screening and the patient has previously flared whilst on the medication; Azathioprine/6MP, if the dose remained constant for 8 weeks prior to the screening visit and had been used continuously for 12 weeks before screening and the patient has previously flared whilst on the medication. Proprietary probiotic preparations must be stopped at least two weeks prior to starting the trial preparation.
* Concomitant use of any other immunosuppressant eg. Methotrexate, tacrolimus, cyclosporine, mycophenolate mofetil, must be at a stable dose of 8 weeks continuous use for 12 weeks prior to screening and the patient has previously flared whilst on the medication.
* Subjects must demonstrate their willingness to participate in the study and comply with the proceedings by signing a written informed consent.
* Men and women =18 to < 75 years of age of any race and gender
* Subjects must be free of any clinically significant disease, other than Crohn's disease, that would interfere with the study's evaluations.
* Subjects should understand and be able to adhere to the dosing and visit schedules; and agree to record symptom severity scores, medication times, concomitant medications and adverse events accurately and consistently in a daily diary.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients should not be enrolled into the study if they meet any of the following criteria:

* Patients with Ulcerative colitis
* Patients with fistulising CD or isolated small bowel CD
* Patients with a CDAI =150 at week 0
* Patients on prednisone, budesonide or any form of corticosteroids for the treatment of CD.
* Patients who are incapacitated, largely or wholly bed-ridden or confined to wheelchair, and who have little or no capacity for self-care
* Symptomatic stenosis or ileal strictures.
* Short bowel syndrome
* Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months. Less serious infections in the previous 3 months, such as acute upper respiratory tract infection (colds) or uncomplicated urinary tract infection need not be considered exclusions at the discretion of the investigator.
* Documented HIV infection.
* Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurological or cerebral disease.
* Any currently known malignancy or pre-malignant lesions or any history of malignancy within the past 5 years.
* Patients with alcoholism, alcoholic liver disease, or other chronic liver disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
6160 - Fremantle

Funding & Sponsors
Primary sponsor type
Other
Name
Orphan Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of the study is to compare the efficacy of the probiotic VSL#3 versus placebo, in addition to standard maintenance drugs, in maintaining remission in Crohn's disease (CD).

The secondary objectives are:

* To determine the time till flare of CD patients on VSL#3 compared to placebo.
* To assess whether concurrent therapy with VSL#3 leads to an improvement in the quality of life (QOL).
* To assess whether concurrent therapy with VSL#3 reduces the severity of a flare if it occurs.
Trial website
https://clinicaltrials.gov/study/NCT00114465
Trial related presentations / publications
Rachmilewitz D, Katakura K, Karmeli F, Hayashi T, Reinus C, Rudensky B, Akira S, Takeda K, Lee J, Takabayashi K, Raz E. Toll-like receptor 9 signaling mediates the anti-inflammatory effects of probiotics in murine experimental colitis. Gastroenterology. 2004 Feb;126(2):520-8. doi: 10.1053/j.gastro.2003.11.019.
Gionchetti P, Rizzello F, Helwig U, Venturi A, Lammers KM, Brigidi P, Vitali B, Poggioli G, Miglioli M, Campieri M. Prophylaxis of pouchitis onset with probiotic therapy: a double-blind, placebo-controlled trial. Gastroenterology. 2003 May;124(5):1202-9. doi: 10.1016/s0016-5085(03)00171-9.
Gionchetti P, Amadini C, Rizzello F, Venturi A, Poggioli G, Campieri M. Diagnosis and treatment of pouchitis. Best Pract Res Clin Gastroenterol. 2003 Feb;17(1):75-87. doi: 10.1053/bega.2002.0348.
Gionchetti P, Amadini C, Rizzello F, Venturi A, Campieri M. Review article: treatment of mild to moderate ulcerative colitis and pouchitis. Aliment Pharmacol Ther. 2002 Jul;16 Suppl 4:13-9. doi: 10.1046/j.1365-2036.16.s4.3.x.
Secondulfo M, de Magistris L, Fiandra R, Caserta L, Belletta M, Tartaglione MT, Riegler G, Biagi F, Corazza GR, Carratu R. Intestinal permeability in Crohn's disease patients and their first degree relatives. Dig Liver Dis. 2001 Nov;33(8):680-5. doi: 10.1016/s1590-8658(01)80045-1.
Public notes

Contacts
Principal investigator
Name 0 0
Ian C Lawrance, MD PhD
Address 0 0
School of Medicine and Pharmacology, University of Western Australia, Fremantle Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00114465