NCT05484102

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Bari · Academic / Other
• Sex: All
• Age: 12 Months – 48 Months
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	milk 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_SUPPLEMENT	placebo 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.

Timeline

• Start date: 2022-09-15
• Primary completion: 2024-01-10
• Completion: 2024-01-11
• First posted: 2022-08-02
• Last updated: 2024-09-19

Locations

1 site across 1 country: Italy