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

Not Applicable

• Conditions: Upper Respiratory Tract Infections; Gastrointestinal Infection; Children, Only
• Interventions: Dietary Supplement: milk fermented with lactobacillus paracasei CBA L74; Dietary Supplement: placebo milk formula

• Registration Number: NCT05484102
• Lead Sponsor: University of Bari

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.

Study Timeline

• Study First Submitted: 2020-09-27
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-29
• Last Update Submitted: 2022-07-29
• Study First Posted: 2022-08-02
• Last Update Posted: 2022-08-02
• Study Start: 2022-09-15
• Primary Completion: 2023-06-15
• Study Completion: 2023-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lactobacillus paracasei CBA L74	milk fermented with lactobacillus paracasei CBA L74	100 enrolled children will receive milk fermented with lactobacillus paracasei CBA L74 daily for 3 months.
placebo	placebo milk formula	100 enrolled children will receive placebo milk formula containing maltodextrins daily for 3 months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Total number of common infectious disease	3 months	evaluate the total number of common infectious disease
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

Trial Locations

Locations (1)

Clinica Pediatrica; 🇮🇹 Bari, Puglia, Italy