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

NCT ID: NCT05484102

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2024-01-11

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.

Conditions

Upper Respiratory Tract Infections; Gastrointestinal Infection; Children, Only

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

lactobacillus paracasei CBA L74

100 enrolled children will receive milk fermented with lactobacillus paracasei CBA L74 daily for 3 months.

Group Type: EXPERIMENTAL

milk fermented with lactobacillus paracasei CBA L74

Intervention Type: DIETARY_SUPPLEMENT

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.

placebo

100 enrolled children will receive placebo milk formula containing maltodextrins daily for 3 months.

Group Type: PLACEBO_COMPARATOR

placebo milk formula

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Healthy children aged 12-48 months
• attending day care or preschool for at least 5 days a week

Exclusion Criteria

• 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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 48 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Heinz Italia SpA

INDUSTRY

Sponsor Role: collaborator

University of Bari

OTHER

Sponsor Role: lead

Responsible Party

Ruggiero Francavilla

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ruggiero francavilla

Role: PRINCIPAL_INVESTIGATOR

University of Bari

Locations

Clinica Pediatrica

Bari, Apulia, Italy

Countries

Italy

References

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Other Identifiers

FERCT19

Identifier Type: -

Identifier Source: org_study_id