NCT04408443

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 vitamin D3 (Reuterin® D3) in the prevention of recurrent respiratory infections in pediatric patients suffered from Recurrent Respiratory Infection (RRI) in previous years.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

May 25, 2020

Last Update Submit

March 21, 2023

Conditions

Recurrent Respiratory Tract Infections

Keywords

RRI, probiotics, vitamin D3, L. reuteri

Outcome Measures

Primary Outcomes (1)

  • Change of the number of respiratory infection

    Change of the number of respiratory infection respect the previous year

    4 months + 2 months of follow up

Secondary Outcomes (6)

  • Change of number of days with fever

    4 months + 2 months of follow up

  • Change of the antibiotic use

    4 months + 2 months of follow up

  • Change of number of visit to Pediatrician

    4 months + 2 months of follow up

  • Change of number of days of absence from the nursery / kindergarten

    4 months + 2 months of follow up

  • Changes of days of absence from work by parents

    4 months + 2 months of follow up

  • +1 more secondary outcomes

Study Arms (2)

Reuterin D3

ACTIVE COMPARATOR

Patients should take 10 drops once a day during meals for 4 months followed by 2 months of follow up.

Dietary Supplement: Lactobacillus reuteri DSM 17938 + Vitamine D3

Placebo

PLACEBO COMPARATOR

Patients should take 10 drops once a day during meals for 4 months followed by 2 months of follow up.

Dietary Supplement: Placebo

Interventions

Lactobacillus reuteri DSM 17938 + Vitamine D3DIETARY_SUPPLEMENT

Lactobacillus reuteri DSM 17938 (10E8 CFU in 5 drops), Vitamin D3 (400 IU in 5 drops), sunflower oil, medium chain triglycerides, silicon dioxide

Reuterin D3
PlaceboDIETARY_SUPPLEMENT

sunflower oil, medium chain triglycerides, silicon dioxide

Placebo

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Participation in other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Campania Luigi Vanvitelli

Naples, 80138, Italy

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Michele Miraglia del Giudice, Prof.

    University of Campania Luigi Vanvitelli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Triple (Participant, Care Provider, Investigator)
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2020

First Posted

May 29, 2020

Study Start

November 25, 2019

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)