VSL#3 Versus Placebo in Maintenance of Remission in Crohn's Disease

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orphan Australia

Criteria

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.

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