|
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: |
NCT01632462 |
|
Date of registration:
|
25/06/2012 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A Prospective, Placebo Controlled, Double-Blind, Cross-over Study on the Effects of a Probiotic Preparation (VSL#3) on Metabolic Profile, Intestinal Permeability, Microbiota, Cytokines and Chemokines Expression and Other Inflammatory Markers in Pediatric Patients With Crohn's Disease
|
|
Scientific title:
|
A Prospective, Placebo Controlled, Double-Blind, Cross-over Study on the Effects of a Probiotic Preparation (VSL#3) on Metabolic Profile, Intestinal Permeability, Microbiota, Cytokines and Chemokines Expression and Other Inflammatory Markers in Pediatric Patients With Crohn's Disease |
|
Date of first enrolment:
|
September 2012 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01632462 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Contacts
|
|
Name:
|
Erasmo Miele, Assistant professor |
|
Address:
|
|
|
Telephone:
|
00390817464565 |
|
Email:
|
erasmo.miele@unina.it |
|
Affiliation:
|
|
|
|
Name:
|
Erasmo Miele, Assistant professor |
|
Address:
|
|
|
Telephone:
|
00390816474565 |
|
Email:
|
erasmo.miele@unina.it |
|
Affiliation:
|
|
|
|
Name:
|
Erasmo Miele, Assistant Professor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Federico II University |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- diagnosis of CD as defined by clinical, radiological, histological and endoscopic
criteria with negative stool culture
- Males and Females ages 5-17 years
- Subjects should have CD in remission as defined by a PCDAI < 10
- Absence of extraintestinal manifestations
- Patients receiving the following treatment:
- Azathioprine: if the dose remained constant for 8 weeks prior to the screening visit
and had been used continuously for 12 weeks before screening associated or not to
5ASA: if the dose remained constant for 4 weeks before the screening visit and had
been used continuously for 8 weeks before screening
- Written informed consent by parents
Exclusion Criteria:
- Patients with Ulcerative Colitis (UC)
- Subjects with documented intestinal stricture, stenosis, obstruction, fistula,
abscess, ileostomy
- Patients with perianal or active CD
- Treatment with anti-TNFa, ciprofloxacin, metronidazole, systemic corticosteroids,
infliximab within 12 weeks of the start of the trial
- Patients with systemic or intestinal infection
- Renal, hepatic, haematological, pulmonary, cardiac, neurologic or cerebral diseases
- Probiotic use in the previous 2 months
- Inability or unwillingness to give an informed consent
- Subjects who require outpatient antibiotic therapy.
- Patients who require surgery for complications related to CD.
- Concurrent participation in an investigational drug trial
- Documented history of allergic reaction to Lactobacillus or other probiotic compound
- Use of Lactobacillus, Bifidobacterium, Enterococcus, Saccharomyces, or any other
probiotic bacterial supplement within the past 10 days
- History of endocarditis, rheumatic valvular disease, congenital cardiac
malformations, or cardiac surgery
- Presence of any other significant medical condition
- Pregnant or breastfeeding female subjects
Age minimum:
5 Years
Age maximum:
17 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Crohn's Disease
|
|
Intervention(s)
|
|
Drug: VSL#3
|
|
Primary Outcome(s)
|
|
to evaluate the effect of a probiotic formulation, VSL#3, versus placebo, on metabolic profile, intestinal permeability, microbiota, cytokines and chemokines expression and other inflammatory markers in pediatric patients with Crohn's Disease
[Time Frame: 22 weeks from the enrollment]
|
|
Secondary Outcome(s)
|
|
To determine the effect on Pediatric Crohn Disease Activity Index (PCDAI);
[Time Frame: 8, 14, 22 weeks from the enrollment]
|
|
to determine the time till flare of CD pediatric patients on VSL#3 compared to placebo.
[Time Frame: 8, 14, 22 weeks from the enrollment]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|