Fermented Milk on the Appearance of Common Winter Infectious Diseases

NCT02367612 | Completed Phase 2

• 1 other identifier: 210/12ES1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Gastroenteritis; Upper Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• The occurrence of common winter infectious diseases involving respiratory and/or gastrointestinal tract

  3 months

Study Arms (2)

Fermented milk

EXPERIMENTAL

Fermented milk with Lactobacillus paracasei CBA L74

Dietary Supplement: Fermented milk

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Fermented milk DIETARY_SUPPLEMENT

Fermented milk with Lactobacillus paracasei CBA L74

Fermented milk

Placebo DIETARY_SUPPLEMENT

Maltodextrin

Placebo

Eligibility Criteria

• Age: 12 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children aged 12-48 months attending educational program (either at nursery or primary school)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Federico II University: lead

Study Sites (3)

university of naples federico II

Naples, Naples, 80131, Italy

Location

Fabio Mosca

Milan, Italy

Location

Giovanni Corsello

Palermo, Italy

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Cultured Milk Products

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Officials

• Roberto Berni Canani, MD, PhD

  Federico II University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: February 20, 2015
• Study Start: December 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 25, 2015

Record last verified: 2015-06

Locations

IT (3)