ClinicalTrials.gov
ClinicalTrials.gov Menu

VSL#3 Treatment in Children With Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00367705
Recruitment Status : Unknown
Verified August 2006 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : August 23, 2006
Last Update Posted : August 18, 2009
Sponsor:
Information provided by:
Hadassah Medical Organization

Brief Summary:
Crohn's disease (CD) in childhood is a chronic relapsing and remitting condition that has a significant impact on growth and development. The disease is characterized by an increased and unregulated immune response. The main therapy over the last 30 years has been corticosteroids leading to remission in 50-80% of patients within 2-4 weeks. However, the use of steroids in children is limited by side-effects including acne, moon-face, hirsutism, hypertension, metabolic disturbances and above all reduced growth. Hence, pediatricians are very interested to find alternative therapies. Therapeutic manipulation of gut flora with probiotics promises to be a useful strategy for several disorders including inflammation of the gut. The efficacy of the highly concentrated probiotic VSL#3 has been documented in maintenance and prophylaxis treatment of pouchitis in double blind, placebo controlled studies in adults. The aim of this study is to compare probiotic therapy with VSL#3 versus placebo in maintenance therapy of children with mild to moderate CD, treated with either 5-ASA, corticosteroids (local or budesonide), imuran/6 mercaptopurine (MP), as long as no change in medication dosage has been made in the previous 12 weeks (for imuran/6MP) or 4 weeks (for corticosteroids).

Condition or disease Intervention/treatment Phase
Crohn's Disease Dietary Supplement: VSL#3® Dietary Supplement: Placebo Phase 4

Detailed Description:

The aim of this study is to compare probiotic therapy with VSL#3 versus placebo in maintenance therapy of children with mild to moderate CD, treated with either 5-ASA, corticosteroids (local or budesonide), imuran/6MP, as long as no change in medication dosage has been made in the previous 12 weeks (for imuran/6MP) or 4 weeks (for corticosteroids). The primary goal will be to compare their ability to maintain remission and to decrease disease activity in each of the two study groups. Data will be collected during this 16 week period regarding the safety and tolerability of VSL#3, as well as data of changes in stool composition of microflora upon treatment.

The follow up will be continued for up to 6 months with a monthly telephone questionnaire and a clinical visit at 6 months.

Study Design:

The study will be a multinational, double-blind, randomized controlled study (Munich, Paris, Rotterdam, Porto, Brussels, London, Warsaw, Chicago, Toronto, Boston, New York, Baltimore, Cleveland, Karachi and Jerusalem).

The study will include 300 children and will last for at least 16 weeks. These children will receive either 1-2 packet according to their weight; each sachet containing 900 billion bacteria/day of VSL#3 or an identical placebo, for 16 weeks.

All patients participating in this study will continue regular medications throughout the study period.

According to the Pediatric Crohn's Disease Activity Index (PCDAI) patients will be assessed clinically at regular intervals and will have stool cultured (including lactobacillus, bifidobacteria and Strep salivarius) as well as a stool calprotectin before and after treatment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind Placebo Controlled Trial of VSL#3 in Children With Crohn's Disease
Study Start Date : August 2009
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Active Comparator: T
VSL-#3
Dietary Supplement: VSL#3®
1-2 sachets/day per os, 6 months

Placebo Comparator: P Dietary Supplement: Placebo
1-2 sachets/day per os, 6 months
Other Name: placebo powder




Primary Outcome Measures :
  1. remission [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children aged 6 - 18 years
  2. Previous diagnosis of Crohn's disease or newly diagnosed with symptoms for at least three months before recruitment to the study.The diagnosis of CD is established by:

    1. history and symptoms of the disease
    2. endoscopy/histology or radiology with negative stool culture.
  3. Written informed consent by parent
  4. PCDAI > 12.5 and < 30
  5. Treatment with 5-ASA, budesonide and imuran/6MP daily provided that the dose has remained stable for the 4 weeks (corticosteroids) or 12 weeks (for imuran/6MP) prior to inclusion. Children treated with other medications (such as anti-TNF or antibiotics including ciprofloxacilin or metronidazole) cannot enter this study.

Exclusion Criteria:

  1. Short bowel syndrome/ileostomy/abscess/fistula/small bowel obstruction/stenosis/stricture
  2. Imminent surgery
  3. Treatment with anti-TNF, systemic corticosteroids, ciprofloxacillin, metronidazole within 12 weeks of the start of the trial.
  4. Participation in another clinical trial within the last 30 days.
  5. Patients should not take antibiotics during the study.
  6. Patients should not take opioids, cholestyramine, ursodeoxycholic acid during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367705


Contacts
Contact: David Branski, MD 00972-2-6777543 branski@hadassah.org.il

Locations
Israel
Hadassah Medical Organization, Not yet recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: David Branski, MD         
Principal Investigator: Michael Wilschanski, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Study Director: David Branski, MD Hadassah Medical Organization
Principal Investigator: Michael Wilschanski, MD Hadassah Medical Organization

Publications:
Responsible Party: Prof. David Branski, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00367705     History of Changes
Other Study ID Numbers: VSL-HMO-CTIL
First Posted: August 23, 2006    Key Record Dates
Last Update Posted: August 18, 2009
Last Verified: August 2006

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases