VSL#3 Treatment in Children With Crohn's Disease
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|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
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Dietary Supplement: VSL#3® Dietary Supplement: Placebo||Phase 4|
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.
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|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Active Comparator: T
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
- remission [ Time Frame: 1 year ]
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
|Contact: David Branski, MDfirstname.lastname@example.org|
|Hadassah Medical Organization,||Not yet recruiting|
|Jerusalem, Israel, 91120|
|Contact: Arik Tzukert, DMD 00 972 2 6776095 email@example.com|
|Contact: Hadas Lemberg, PhD 00 972 2 6777572 firstname.lastname@example.org|
|Principal Investigator: David Branski, MD|
|Principal Investigator: Michael Wilschanski, MD|
|Study Director:||David Branski, MD||Hadassah Medical Organization|
|Principal Investigator:||Michael Wilschanski, MD||Hadassah Medical Organization|