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

NCT00114465 | Completed Phase 4 DMC

• 1 other identifier: VSL#3Freo
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease

Keywords

Randomized; Double-Blind; Probiotic; Remission; Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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)

  2 years

Secondary Outcomes (3)

• Time till flare of CD

  within 1 year of commencing therapy

• To assess whether concurrent therapy with VSL#3 leads to an improvement in the quality of life

  within 1 year of commencing therapy

• To assess whether concurrent therapy with VSL#3 reduces the severity of a flare if it occurs

  within 1 year of commencing therapy

Study Arms (2)

VSL#3

EXPERIMENTAL

Probiotic

Drug: VSL#3

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

VSL#3 DRUG

VSL#3 1 sachet twice a day

VSL#3

Placebo OTHER

Placebo 1 sachel twice a day

Also known as: Blacebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Orphan Australia: lead

Study Sites (1)

Fremantle Hospital

Fremantle, Western Australia, 6160, Australia

Location

Related Publications (5)

• 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.

  PMID: 14762789 BACKGROUND

• 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.

  PMID: 12730861 BACKGROUND

• 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.

  PMID: 12617884 BACKGROUND

• 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.

  PMID: 12047254 BACKGROUND

• 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.

  PMID: 11785714 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Ian C Lawrance, MD PhD

  School of Medicine and Pharmacology, University of Western Australia, Fremantle Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 14, 2005
• First Posted: June 15, 2005
• Study Start: June 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 18, 2009

Record last verified: 2009-09

Locations

AU (1)