Fermented Milk on the Appearance of Common Winter Infectious Diseases

Upper Respiratory Tract Infections Clinical Trial

Official title:

Fermented Milk on the Appearance of Common Winter Infectious Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367612
• Other study ID #: 210/12ES1
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2015
• Last updated: June 24, 2015
• Start date: December 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 48 Months

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Communicable Diseases
• Gastroenteritis
• Infection
• Respiratory Tract Infections
• Upper Respiratory Tract Infections

Intervention

Dietary Supplement:
• Fermented milk
Fermented milk with Lactobacillus paracasei CBA L74
• Placebo
Maltodextrin

Locations

Country	Name	City	State
Italy	Fabio Mosca	Milan
Italy	university of naples federico II	Naples
Italy	Giovanni Corsello	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of common winter infectious diseases involving respiratory and/or gastrointestinal tract		3 months	No