Clinical trial NCT05484102: Preventive Effect of Cow's Milk Fermented With Lactobacillus Paracasei CBA L74 on Common Infectious Diseases in Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Tract Infections
Gastrointestinal Infection
Children, Only
Keywords: Lactobacillus paracasei CBA L74
fermented milk
Lead sponsor: University of Bari
Sponsor class: OTHER
Collaborators: name: Heinz Italia SpA
First posted: 2022-08-02
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind randomized placebo controlled clinical trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: preventive effect of cow's milk fermented with Lactobacillus paracasei CBA L74 on common infectious disease
timeFrame: 3 months
Secondary outcomes:
measure: Total number of common infectious disease
timeFrame: 3 months
measure: use of medications
timeFrame: 3 months
measure: emergency department medical examinations and hospitalizations
timeFrame: 3 months
measure: days of work lost by the parents
timeFrame: 3 months
measure: days of school lost by the children
timeFrame: 3 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Clinica Pediatrica
state: Puglia
Study officials:
affiliation: University of Bari
name: ruggiero francavilla
role: PRINCIPAL_INVESTIGATOR
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