|
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:
|
3 August 2015 |
|
Main ID: |
NCT02367612 |
|
Date of registration:
|
12/02/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Fermented Milk on the Appearance of Common Winter Infectious Diseases
|
|
Scientific title:
|
Fermented Milk on the Appearance of Common Winter Infectious Diseases |
|
Date of first enrolment:
|
December 2014 |
|
Target sample size:
|
140 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02367612 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Contacts
|
|
Name:
|
Roberto Berni Canani, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Federico II University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- children aged 12-48 months attending educational program (either at nursery or
primary school)
Exclusion Criteria:
- concomitant chronic/congenital diseases and disabilities
- active tubercolosis
- congenital cardiac defects
- autoimmune diseases
- immunodeficiency
- cystic fibrosis
- metabolic diseases
- malignancy
.chronic pulmonary diseases
- malformation of he GI tract
- food allergy
- antibiotic use
- pre/pro/symbiotic use
- severe wasting (less than 3 standard deviations of weight-for-height z score)
Age minimum:
12 Months
Age maximum:
48 Months
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Acute Gastroenteritis
|
|
Upper Respiratory Tract Infections
|
|
Intervention(s)
|
|
Dietary Supplement: Placebo
|
|
Dietary Supplement: Fermented milk
|
|
Primary Outcome(s)
|
|
The occurrence of common winter infectious diseases involving respiratory and/or gastrointestinal tract
[Time Frame: 3 months]
|
|
Secondary ID(s)
|
|
210/12ES1
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|