Children, Only, Gastrointestinal Infection, Upper Respiratory Tract Infections
Conditions
Keywords
Lactobacillus paracasei CBA L74, fermented milk
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTmilk fermented with lactobacillus paracasei CBA L74
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.
DIETARY_SUPPLEMENTplacebo milk formula
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.
Sponsors
Heinz Italia SpA
University of Bari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Enrolled children will be randomly assigned, with the use of a computer-generated randomization list to receive milk fermented with Lactobacillus paracasei CBA L74 or placebo
Intervention model description
double blind randomized placebo controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
12 Months to 48 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy children aged 12-48 months * attending day care or preschool for at least 5 days a week
Exclusion criteria
The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| preventive effect of cow's milk fermented with Lactobacillus paracasei CBA L74 on common infectious disease | 3 months | the rate of children experiencing at least one episode of common infectious disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total number of common infectious disease | 3 months | evaluate the total number of common infectious disease |
| use of medications | 3 months | use of medications (antibiotics, antipyretics, steroids) |
| emergency department medical examinations and hospitalizations | 3 months | access to emergency department medical examinations and hospitalizations |
| days of work lost by the parents | 3 months | evaluation of days of work lost by the parents |
| days of school lost by the children | 3 months | evaluation of days of school lost by the children |
Countries
Italy
Outcome results
None listed