Treatment with pidotimod and bifidobacteria in children with respiratory infections

Combined treatment with pidotimod and bifidobacteria in pre-scholastic age children with recurrent respiratory infections: evaluation of clinical efficacy and parents' quality of life - MB0515/1021/03

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002733-22-IT

Enrollment

116

Registered

2018-04-03

Start date

2015-09-09

Completion date

Unknown

Last updated

2018-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent respiratory infections MedDRA version: 20.0 Level: PT Classification code 10062352 Term: Respiratory tract infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: AXIL - 400 MG/7 ML SOLUZIONE ORALE 10 CONTENITORI MONODOSE DA 7 ML Product Name: AXIL 400 mg/7 ml soluzione orale Pharmaceutical Form: Oral solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children: - both sex aged 3-6 years; - integrated in scholastic ambient (nursery school, kindergarten); - affected by recurrent respiratory infections defined as: .. 6 or more episodes in the previous year: 01/10/2014 - 30/09/2015; .. 1 or more episodes/month in the period september-april of the previous year: 01/09/2014 - 20/054/2015; .. 3 or more lower respiratory tract infections in the previous year: 01/10/2014 - 30/09/2015; - whose parents have given the appropriate consent to the study partecipation of their son. Are the trial subjects under 18? yes Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - ongoing respiratory infection or other infections requiring hospitalization; - story of bronchospasm; - cardiopathies or severe systemic disease; - chronic respiratory diseases (like cystic fibrosis and primary ciliary dyskinesia); - immunodeficiencies; - treatment in the last 4 weeks with probiotics, corticosteroids, immunostimulants or immunosuppressants; - allergies or intolerance to pidotimod.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate in pre-scholastic age children with recurrent respiratory infections the effects of the treatment with pidotimod and/or bifidobacteria on the prevention of respiratory infections.;Secondary Objective: To evaluate both the duration and the intensity of respiratory infections, the QUolity of Life of parents, the tolerability and safety of the treatments.;Primary end point(s): Number of respiratory infections;Timepoint(s) of evaluation of this end point: At sixth month	—

Measure

Time frame

Main Objective: To evaluate in pre-scholastic age children with recurrent respiratory infections the effects of the treatment with pidotimod and/or bifidobacteria on the prevention of respiratory infections.;Secondary Objective: To evaluate both the duration and the intensity of respiratory infections, the QUolity of Life of parents, the tolerability and safety of the treatments.;Primary end point(s): Number of respiratory infections;Timepoint(s) of evaluation of this end point: At sixth month

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Secondary

Measure	Time frame
Secondary end point(s): In relation to the respiratory infection episodes only: - Duration of the episodes - Days of treatment with antibiotic - Nr. of visits to the Doctor - Nr. of entries to the Emergency Room - Nr. and duration of hospitalizations - Nr. of days of absence from school - Nr. of days of absence from work for parents - Nr. of hours of baby sitting required Questionnaire on Quality of Life of parents;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Secondary end point(s): In relation to the respiratory infection episodes only: - Duration of the episodes - Days of treatment with antibiotic - Nr. of visits to the Doctor - Nr. of entries to the Emergency Room - Nr. and duration of hospitalizations - Nr. of days of absence from school - Nr. of days of absence from work for parents - Nr. of hours of baby sitting required Questionnaire on Quality of Life of parents;Timepoint(s) of evaluation of this end point: 6 months

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Countries

Italy

Contacts

Public ContactClinical Department

VALEAS SPA

dir.medica@valeas.it0223690215

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026