Preventive Effect of Cow's Milk Fermented With Lactobacillus Paracasei CBA L74 on Common Infectious Diseases in Children

Study Overview
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Brief Summary
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this is a double-blind randomized placebo controlled clinical trial. 200 healthy children aged 12-48 months, attending day care or preschool for at least 5 days a week, regularly checked by the family pediatrician (FP) involved in the trial, were considered for the study and consecutively contacted during scheduled medical examinations at the FPs office. study plan is 3-month treatment period. The clinical evaluation will be carried out at enrollment, at 30, 60 and 90 days from the beginning of the treatment by the pediatrician. fecal and nasal mucus samples for immunological and microbiological analysis will be collected before the treatment and at 90 days (end of treatment).

Detailed Description
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Subjects were supplemented daily for 3 months with cow's skim milk fermented with L. paracasei CBA L74 (group A) or placebo (group B).Enrolled children will be randomly assigned, with the use of a computer-generated randomization list to receive either milk fermented with Lactobacillus paracasei CBA L74 or placebo once. Placebo and fermented milk had the same shape, the placebo's taste, dimension, indication, and appearance. At enrollment the family pediatricians consulted the clinical records of each child for previous diseases and pharmacological treatments. At the baseline, after obtaining informed consent from the parents/tutors of each child, the health status of all the study subjects was carefully assessed, and the presence of infectious diseases or other disease was ruled out by means of a complete physical examination, including vital signs (body temperature, pulse rate, respiration rate, blood pressure); neurological status; body growth status; nutritional status; hydration; skin evaluation; otoscopy; evaluation of oral cavity; respiratory/abdomen/lymphonode examination; and genital examination. A diary will be given to the parents; on a daily basis, patients will monitor and record the frequency/severity of symptoms, episodes of respiratory and/or gastrointestinal infection and their duration and school absence on the diary. Fecal Analysis: three fecal samples for microbiological and immunological analysis will be collected before treatment and at 90 days (end of treatment). Nasal mucus samples for immunological analysis will be collected before the treatment and at 90 days (end of the treatment). The study was approved by the Ethics Committee of the Universities of Bari.

Official Title
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Preventive Effect of Cow's Milk Fermented With Lactobacillus Paracasei CBA L74 on Upper Respiratory Tract and Gastrointestinal Infectious Diseases in Children: a Double-blind, Randomized, Placebo-controlled Trial

Conditions
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Upper Respiratory Tract Infections, Gastrointestinal Infection, Children, Only

Intervention / Treatment
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* Dietary Supplement: milk fermented with lactobacillus paracasei CBA L74
* Dietary Supplement: placebo milk formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children aged 12-48 months attending day care or preschool for at least 5 days a week Exclusion Criteria: The exclusion criteria were: age <12 months or >48 months concomitant chronic infections, chronic systemic diseases, chronic inflammatory bowel diseases, autoimmune diseases, immunodeficiency, malignancy, metabolic diseases chronic respiratory tract diseases including respiratory allergies and cystic fibrosis malformations of gastrointestinal or urinary or respiratory tract history of respiratory or gastrointestinal or urinary tract surgery congenital cardiac defects functional bowel disorders suspected or challenge-proved food allergy, food intolerances severe malnutrition (z-score for weight-for-height <3 standard deviation scores) use of antibiotics or pre/pro/synbiotics or immune stimulating products in the 2 weeks before the enrolment Siblings of subjects enrolled in the study were not allowed to participate to the trial.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 48 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blind randomized placebo controlled clinical trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lactobacillus paracasei CBA L74<br>100 enrolled children will receive milk fermented with lactobacillus paracasei CBA L74 daily for 3 months. | Dietary Supplement: milk fermented with lactobacillus paracasei CBA L74<br>* milk fermented with lactobacillus paracasei CBA L74 will be administered daily for 3 months to 100 children. Participants were supplied with the milk product in powder form, by Heinz Italia SpA, Segrate, Italy. The study products were provided in tins containing 400 g of powder, and the packaging was similar and the tins were stored at room temperature in a dry environment. The family pediatricians instructed parents about the daily amount of the assigned study product and the method of preparation. All subjects received 7 g/day of study products diluted in a maximum of 150 mL of cow's milk or water. After dilution, the look and the taste were the same for all of the study products.<br>|
| Placebo Comparator: placebo<br>100 enrolled children will receive placebo milk formula containing maltodextrins daily for 3 months. | Dietary Supplement: placebo milk formula<br>* placebo milk formula containing maltodextrins will be administered daily for 3 months to 100 children. The study products were provided in tins containing 400 g of powder, and the packaging was similar and the tins were stored at room temperature in a dry environment. The family pediatricians instructed parents about the daily amount of the assigned study product and the method of preparation. All subjects received 7 g/day of study products diluted in a maximum of 150 mL of cow's milk or water. After dilution, the look and the taste were the same for all of the study products.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preventive effect of cow's milk fermented with Lactobacillus paracasei CBA L74 on common infectious disease | the rate of children experiencing at least one episode of common infectious disease | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of common infectious disease | evaluate the total number of common infectious disease | 3 months | 
| use of medications | use of medications (antibiotics, antipyretics, steroids) | 3 months | 
| emergency department medical examinations and hospitalizations | access to emergency department medical examinations and hospitalizations | 3 months | 
| days of work lost by the parents | evaluation of days of work lost by the parents | 3 months | 
| days of school lost by the children | evaluation of days of school lost by the children | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lactobacillus paracasei CBA L74, fermented milk