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

Children, Only Clinical Trial

— FERCT19  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05484102
• Other study ID #: FERCT19
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: September 15, 2023

Study information

• Verified date: July 2022
• Source: University of Bari
• Contact: Ruggiero Francavilla, professor
• Phone: +390805592847
• Email: ruggiero.francavilla[@]uniba.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 48 Months

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Clinica Pediatrica	Bari	Puglia

Sponsors (2)

Lead Sponsor	Collaborator
University of Bari	Heinz Italia SpA

Country where clinical trial is conducted

Italy, 

References & Publications (10)

Brunser O, Araya M, Espinoza J, Guesry PR, Secretin MC, Pacheco I. Effect of an acidified milk on diarrhoea and the carrier state in infants of low socio-economic stratum. Acta Paediatr Scand. 1989 Mar;78(2):259-64. — View Citation

Campeotto F, Suau A, Kapel N, Magne F, Viallon V, Ferraris L, Waligora-Dupriet AJ, Soulaines P, Leroux B, Kalach N, Dupont C, Butel MJ. A fermented formula in pre-term infants: clinical tolerance, gut microbiota, down-regulation of faecal calprotectin and — View Citation

Hill C, Guarner F, Reid G, Gibson GR, Merenstein DJ, Pot B, Morelli L, Canani RB, Flint HJ, Salminen S, Calder PC, Sanders ME. Expert consensus document. The International Scientific Association for Probiotics and Prebiotics consensus statement on the sco — View Citation

Maldonado J, Cañabate F, Sempere L, Vela F, Sánchez AR, Narbona E, López-Huertas E, Geerlings A, Valero AD, Olivares M, Lara-Villoslada F. Human milk probiotic Lactobacillus fermentum CECT5716 reduces the incidence of gastrointestinal and upper respirator — View Citation

Merenstein D, Murphy M, Fokar A, Hernandez RK, Park H, Nsouli H, Sanders ME, Davis BA, Niborski V, Tondu F, Shara NM. Use of a fermented dairy probiotic drink containing Lactobacillus casei (DN-114 001) to decrease the rate of illness in kids: the DRINK s — View Citation

Nagata S, Asahara T, Ohta T, Yamada T, Kondo S, Bian L, Wang C, Yamashiro Y, Nomoto K. Effect of the continuous intake of probiotic-fermented milk containing Lactobacillus casei strain Shirota on fever in a mass outbreak of norovirus gastroenteritis and t — View Citation

Nocerino R, Paparo L, Terrin G, Pezzella V, Amoroso A, Cosenza L, Cecere G, De Marco G, Micillo M, Albano F, Nugnes R, Ferri P, Ciccarelli G, Giaccio G, Spadaro R, Maddalena Y, Berni Canani F, Berni Canani R. Cow's milk and rice fermented with Lactobacill — View Citation

Perna A, Intaglietta I, Simonetti A, Gambacorta E. Effect of genetic type and casein haplotype on antioxidant activity of yogurts during storage. J Dairy Sci. 2013 Jun;96(6):3435-41. doi: 10.3168/jds.2012-5859. Epub 2013 Mar 30. — View Citation

Tamang JP, Shin DH, Jung SJ, Chae SW. Functional Properties of Microorganisms in Fermented Foods. Front Microbiol. 2016 Apr 26;7:578. doi: 10.3389/fmicb.2016.00578. eCollection 2016. Review. — View Citation

Tamang JP, Watanabe K, Holzapfel WH. Review: Diversity of Microorganisms in Global Fermented Foods and Beverages. Front Microbiol. 2016 Mar 24;7:377. doi: 10.3389/fmicb.2016.00377. eCollection 2016. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preventive effect of cow's milk fermented with Lactobacillus paracasei CBA L74 on common infectious disease	the rate of children experiencing at least one episode of common infectious disease	3 months
Secondary	Total number of common infectious disease	evaluate the total number of common infectious disease	3 months
Secondary	use of medications	use of medications (antibiotics, antipyretics, steroids)	3 months
Secondary	emergency department medical examinations and hospitalizations	access to emergency department medical examinations and hospitalizations	3 months
Secondary	days of work lost by the parents	evaluation of days of work lost by the parents	3 months
Secondary	days of school lost by the children	evaluation of days of school lost by the children	3 months