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

NCT05484102 | Completed

• 1 other identifier: FERCT19
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Upper Respiratory Tract Infections; Gastrointestinal Infection; Children, Only

Keywords

Lactobacillus paracasei CBA L74; fermented milk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Total number of common infectious disease

  3 months

• use of medications

  3 months

• emergency department medical examinations and hospitalizations

  3 months

• days of work lost by the parents

  3 months

• days of school lost by the children

  3 months

Study Arms (2)

lactobacillus paracasei CBA L74

EXPERIMENTAL

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

Dietary Supplement: milk fermented with lactobacillus paracasei CBA L74

placebo

PLACEBO COMPARATOR

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

Dietary Supplement: placebo milk formula

Interventions

milk fermented with lactobacillus paracasei CBA L74 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.

lactobacillus paracasei CBA L74

placebo milk formula 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.

placebo

Eligibility Criteria

• Age: 12 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bari: lead
• Heinz Italia SpA: collaborator

Study Sites (1)

Clinica Pediatrica

Bari, Apulia, 70125, Italy

Location

Related Publications (10)

• Maldonado J, Canabate F, Sempere L, Vela F, Sanchez AR, Narbona E, Lopez-Huertas E, Geerlings A, Valero AD, Olivares M, Lara-Villoslada F. Human milk probiotic Lactobacillus fermentum CECT5716 reduces the incidence of gastrointestinal and upper respiratory tract infections in infants. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):55-61. doi: 10.1097/MPG.0b013e3182333f18.

  PMID: 21873895 RESULT

• 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.

  PMID: 27199913 RESULT

• 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.

  PMID: 27047484 RESULT

• 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 scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol. 2014 Aug;11(8):506-14. doi: 10.1038/nrgastro.2014.66. Epub 2014 Jun 10.

  PMID: 24912386 RESULT

• 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.

  PMID: 23548278 RESULT

• 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 study. A patient-oriented, double-blind, cluster-randomized, placebo-controlled, clinical trial. Eur J Clin Nutr. 2010 Jul;64(7):669-77. doi: 10.1038/ejcn.2010.65. Epub 2010 May 19.

  PMID: 20485304 RESULT

• 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. doi: 10.1111/j.1651-2227.1989.tb11066.x.

  PMID: 2929349 RESULT

• 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 up-regulation of faecal secretory IgA. Br J Nutr. 2011 Jun 28;105(12):1843-51. doi: 10.1017/S0007114510005702. Epub 2011 Mar 22.

  PMID: 21426607 RESULT

• 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 the faecal microflora in a health service facility for the aged. Br J Nutr. 2011 Aug;106(4):549-56. doi: 10.1017/S000711451100064X. Epub 2011 Apr 27.

  PMID: 21521545 RESULT

• 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 Lactobacillus paracasei CBA L74 prevent infectious diseases in children: A randomized controlled trial. Clin Nutr. 2017 Feb;36(1):118-125. doi: 10.1016/j.clnu.2015.12.004. Epub 2015 Dec 17.

  PMID: 26732025 RESULT

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• ruggiero francavilla

  University of Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Enrolled children will be randomly assigned, with the use of a computer-generated randomization list to receive milk fermented with Lactobacillus paracasei CBA L74 or placebo
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: double blind randomized placebo controlled clinical trial

Study Record Dates

• First Submitted: September 27, 2020
• First Posted: August 2, 2022
• Study Start: September 15, 2022
• Primary Completion: January 10, 2024
• Study Completion: January 11, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)