VSL#3 Treatment in Children With Crohn's Disease
Crohn's Disease
About this trial
This is an interventional treatment trial for Crohn's Disease
Eligibility Criteria
Inclusion Criteria: Children aged 6 - 18 years 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: history and symptoms of the disease endoscopy/histology or radiology with negative stool culture. Written informed consent by parent PCDAI > 12.5 and < 30 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: Short bowel syndrome/ileostomy/abscess/fistula/small bowel obstruction/stenosis/stricture Imminent surgery Treatment with anti-TNF, systemic corticosteroids, ciprofloxacillin, metronidazole within 12 weeks of the start of the trial. Participation in another clinical trial within the last 30 days. Patients should not take antibiotics during the study. Patients should not take opioids, cholestyramine, ursodeoxycholic acid during the study.
Sites / Locations
- Hadassah Medical Organization,
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
T
P
VSL-#3