Status:
TERMINATED
Evaluation of Lactobacillus Reuteri DSM 17938 + Vitamin D3 in the Prevention of RRI in Paediatric Patients
Lead Sponsor:
Noos S.r.l.
Conditions:
Recurrent Respiratory Tract Infections
Eligibility:
All Genders
1-6 years
Phase:
NA
Brief Summary
The aim of this protocol is to evaluate, in a multicenter, randomized, double blind vs placebo clinical trial the effects of a marketed food supplement containing Lactobacillus reuteri DSM 17938 and v...
Detailed Description
Several clinical trials documented the efficacy of probiotics in the prevention and treatment of acute gastroenteritis, while there is little evidence on the efficacy of the probiotics in the preventi...
Eligibility Criteria
Inclusion
- Patients between 1 and 6 years of age at the enrollment; both sexes
- Patients with an history of RRI, according to the definition (The definition of Recurrent respiratory infections (RRI) is the onset of 8 or more documented airway infections during the year, in preschool children (up to three years of age) or 6 or more in children older 3 years, in the absence of any other underlying pathological condition) in the previous year.
- Atopic and non-atopic patients
- Willing and able to give informed consent of participation in the study by parent or legal guardian.
Exclusion
- Presence of autoimmune diseases, immunodeficiency, neuromuscular diseases, congenital cardiomyopathies, metabolic diseases
- Patients in therapy with other drugs for the treatment of RRI
- Supplementation with probiotics and /or prebiotics in the previous 2 weeks
- Vitamin D intake in the last 4 weeks
- IgA deficiency
- Antibiotic treatment at least 4 week before in inclusion
- Participation in other clinical trials
Key Trial Info
Start Date :
November 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04408443
Start Date
November 25 2019
End Date
September 30 2021
Last Update
March 23 2023
Active Locations (1)
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1
University of Campania Luigi Vanvitelli
Naples, Italy, 80138