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Trial record 7 of 33 for:    Roberto Berni Canani

Fermented Milk on the Appearance of Common Winter Infectious Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02367612
Recruitment Status : Completed
First Posted : February 20, 2015
Last Update Posted : June 25, 2015
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University

Brief Summary:

Respiratory and gastrointestinal infections are common in children under the age of 4 years, especially after the start of schooling. These conditions are facilitated by a still incomplete functional maturation of the immune system and the anatomical structure and function of the respiratory and gastrointestinal tract still developing. The frequency and duration of these conditions involves a high discomfort and significant costs, in relation to medical appointments, taking medication, the need for hospitalization, days of absence from school and work days lost by parents. Functional foods derived from the fermentation of cow's milk with probiotic strains have been proposed for the prevention of infectious diseases in children. Several products have been investigated, with sometimes conflicting results. Diversity in experimental designs, populations evaluated, and bacterial strains used in the preparation of fermented products are probably responsible for these discrepancies. Recently we started a study approved by the Ethics Committee for Biomedical Activities "Carlo Romano" of the University of Naples "Federico II" (protocol number 210/12) to evaluate the effectiveness of foods fermented with Lactobacillus paracasei CBA-L74 in the prevention of common winter infections in school children aged between 12 and 48 months. Studies of pre-clinical phase showed anti-inflammatory activity of milk fermented with the strain Lactobacillus paracasei L74-CBA in terms of stimulation of the production of the cytokine IL-10 and decreased synthesis of IL-12, also in response to stimulation with Salmonella typhimurium. The data were obtained in in vitro studies on dendritic cells and ex vivo intestinal biopsies as well as in tests on healthy mice and on a mouse model of experimental colitis. A preliminary analysis of the data was found that subjects treated with fermented milk showed fewer infectious episodes, as well as a lower incidence of respiratory tract infections or gastrointestinal, with a statistically significant difference between the study groups. It was also observed a significant increase in the levels of α- and β- defensins, LL-37 and secretory IgA in the group of subjects treated with fermented milk compared to subjects treated with fermented rice or placebo.

Therefore, we decided to extend the period of study of five additional months, in order to perform an evaluation of the effectiveness of fermented milk (which was more effective)vs placebo.

Condition or disease Intervention/treatment Phase
Acute Gastroenteritis Upper Respiratory Tract Infections Dietary Supplement: Fermented milk Dietary Supplement: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Fermented Milk on the Appearance of Common Winter Infectious Diseases
Study Start Date : December 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: Fermented milk
Fermented milk with Lactobacillus paracasei CBA L74
Dietary Supplement: Fermented milk
Fermented milk with Lactobacillus paracasei CBA L74

Placebo Comparator: Placebo
Dietary Supplement: Placebo

Primary Outcome Measures :
  1. The occurrence of common winter infectious diseases involving respiratory and/or gastrointestinal tract [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • children aged 12-48 months attending educational program (either at nursery or primary school)

Exclusion Criteria:

  • concomitant chronic/congenital diseases and disabilities
  • active tubercolosis
  • congenital cardiac defects
  • autoimmune diseases
  • immunodeficiency
  • cystic fibrosis
  • metabolic diseases
  • malignancy

    .chronic pulmonary diseases

  • malformation of he GI tract
  • food allergy
  • antibiotic use
  • pre/pro/symbiotic use
  • severe wasting (less than 3 standard deviations of weight-for-height z score)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02367612

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Fabio Mosca
Milan, Italy
university of naples federico II
Naples, Italy, 80131
Giovanni Corsello
Palermo, Italy
Sponsors and Collaborators
Federico II University
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Study Director: Roberto Berni Canani, MD, PhD Federico II University
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Responsible Party: Roberto Berni Canani, MD, PhD, Federico II University Identifier: NCT02367612    
Other Study ID Numbers: 210/12ES1
First Posted: February 20, 2015    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Gastrointestinal Diseases
Digestive System Diseases