Fermented Milk on the Appearance of Common Winter Infectious Diseases
Primary Purpose
Acute Gastroenteritis, Upper Respiratory Tract Infections
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Fermented milk
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Acute Gastroenteritis
Eligibility 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)
Sites / Locations
- Fabio Mosca
- university of naples federico II
- Giovanni Corsello
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fermented milk
Placebo
Arm Description
Fermented milk with Lactobacillus paracasei CBA L74
Placebo
Outcomes
Primary Outcome Measures
The occurrence of common winter infectious diseases involving respiratory and/or gastrointestinal tract
Secondary Outcome Measures
Full Information
NCT ID
NCT02367612
First Posted
February 12, 2015
Last Updated
June 24, 2015
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT02367612
Brief Title
Fermented Milk on the Appearance of Common Winter Infectious Diseases
Official Title
Fermented Milk on the Appearance of Common Winter Infectious Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Respiratory and gastrointestinal infections are common in children under the age of 4 years, especially after the start of schooling. These conditions are facilitated by a still incomplete functional maturation of the immune system and the anatomical structure and function of the respiratory and gastrointestinal tract still developing. The frequency and duration of these conditions involves a high discomfort and significant costs, in relation to medical appointments, taking medication, the need for hospitalization, days of absence from school and work days lost by parents. Functional foods derived from the fermentation of cow's milk with probiotic strains have been proposed for the prevention of infectious diseases in children. Several products have been investigated, with sometimes conflicting results. Diversity in experimental designs, populations evaluated, and bacterial strains used in the preparation of fermented products are probably responsible for these discrepancies. Recently we started a study approved by the Ethics Committee for Biomedical Activities "Carlo Romano" of the University of Naples "Federico II" (protocol number 210/12) to evaluate the effectiveness of foods fermented with Lactobacillus paracasei CBA-L74 in the prevention of common winter infections in school children aged between 12 and 48 months. Studies of pre-clinical phase showed anti-inflammatory activity of milk fermented with the strain Lactobacillus paracasei L74-CBA in terms of stimulation of the production of the cytokine IL-10 and decreased synthesis of IL-12, also in response to stimulation with Salmonella typhimurium. The data were obtained in in vitro studies on dendritic cells and ex vivo intestinal biopsies as well as in tests on healthy mice and on a mouse model of experimental colitis. A preliminary analysis of the data was found that subjects treated with fermented milk showed fewer infectious episodes, as well as a lower incidence of respiratory tract infections or gastrointestinal, with a statistically significant difference between the study groups. It was also observed a significant increase in the levels of α- and β- defensins, LL-37 and secretory IgA in the group of subjects treated with fermented milk compared to subjects treated with fermented rice or placebo.
Therefore, we decided to extend the period of study of five additional months, in order to perform an evaluation of the effectiveness of fermented milk (which was more effective)vs placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gastroenteritis, Upper Respiratory Tract Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fermented milk
Arm Type
Experimental
Arm Description
Fermented milk with Lactobacillus paracasei CBA L74
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Fermented milk
Intervention Description
Fermented milk with Lactobacillus paracasei CBA L74
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Maltodextrin
Primary Outcome Measure Information:
Title
The occurrence of common winter infectious diseases involving respiratory and/or gastrointestinal tract
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Berni Canani, MD, PhD
Organizational Affiliation
Federico II University
Official's Role
Study Director
Facility Information:
Facility Name
Fabio Mosca
City
Milan
Country
Italy
Facility Name
university of naples federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Giovanni Corsello
City
Palermo
Country
Italy
12. IPD Sharing Statement
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Fermented Milk on the Appearance of Common Winter Infectious Diseases
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