ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00367705
Date of registration:	22/08/2006
Prospective Registration:	Yes
Primary sponsor:	Hadassah Medical Organization
Public title:	VSL#3 Treatment in Children With Crohn's Disease
Scientific title:	Double-blind Placebo Controlled Trial of VSL#3 in Children With Crohn's Disease
Date of first enrolment:	August 2009
Target sample size:	300
Recruitment status:	Not yet recruiting
URL:	http://clinicaltrials.gov/show/NCT00367705
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Phase:	Phase 4

Countries of recruitment
Israel

Contacts

Name:	Arik Tzukert, DMD
Address:
Telephone:	00 972 2 6776095
Email:	arik@hadassah.org.il
Affiliation:

Name:	Michael Wilschanski, MD
Address:
Telephone:
Email:
Affiliation:	Hadassah Medical Organization

Name:	David Branski, MD
Address:
Telephone:	00972-2-6777543
Email:	branski@hadassah.org.il
Affiliation:

Name:	David Branski, MD
Address:
Telephone:
Email:
Affiliation:	Hadassah Medical Organization

Key inclusion & exclusion 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.

Age minimum: 6 Years
Age maximum: 18 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Dietary Supplement: VSL#3®

Dietary Supplement: Placebo

Primary Outcome(s)

remission [Time Frame: 1 year]

Secondary Outcome(s)

Secondary ID(s)

VSL-HMO-CTIL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.