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Probiotics in Paediatric Asthma Management (ProPAM)

Primary Purpose

Asthma in Children

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Bifiasthm

Placebo

About this trial

This is an interventional treatment trial for Asthma in Children

Eligibility Criteria

1 Year - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The study will include all children aged 6 to 14, with slight and moderate persistent asthma according to GINA 2015 criteria (asthma classification did not change in GINA 2015 and 2016 guidelines), whether or not showing positive skin allergometric tests, as well as all children aged 2 yrs, 364 days to 5 years, 364 days, with recurring wheezing, whether or not diagnosed with asthma (positive and/or negative prick).

Exclusion Criteria:

Severe persistent asthma
Known congenital or acquired immunodeficiencies
Cystic fibrosis
Chronic pulmonary diseases (bronchodysplasia)
Age < 1 yr, 364d and 14 yrs

Sites / Locations

Primary Care Ambulatory

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

probiotic treatment

Placebo treatment

Arm Description

For the first 8 weeks was administered 1 sachet in the morning and 1 in the evening, for the last 8 weeks was administered 1 sachet per day Lactobacillus salivarius LS01 (DSM 22775): 10^9 CFU Bifidobacterium breve B632 (DSM 24706): 10^9 CFU Maltodextrin and silicon dioxide

For the first 8 weeks was administered 1 sachet in the morning and 1 in the evening, for the last 8 weeks was administered 1 sachet per day Maltodextrin and silicon dioxide

Outcomes

Primary Outcome Measures

Reduction in Asthma episodes

Reduction in the frequency and severity of asthma crises, the evaluation is performed using Guidelines for management of Asthma, Italian Society of Pediatricians

Reduction in wheezing

Reduction in the frequency of wheezing episodes, numerical evaluation.

Secondary Outcome Measures

Reduction of adminstrated drug quantity

Reduction in the administered drug quantity for asthma crisis treatment

Reduction in treatment time

use of short-term treatments

Full Information

NCT ID

NCT04289441

First Posted

January 23, 2020

Last Updated

January 25, 2023

Sponsor

Probiotical S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT04289441

Brief Title

Probiotics in Paediatric Asthma Management

Acronym

ProPAM

Official Title

"Randomized Controlled Double-blind Trial With Lactobacillus Salivarius LS01 (DSM 22775) and Bifidobacterium Breve B632 (DSM 24706) for Paediatric Asthma Management"

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

April 21, 2017 (Actual)

Primary Completion Date

April 21, 2019 (Actual)

Study Completion Date

November 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Probiotical S.p.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Randomized controlled double-blind trial in a child population with allergic asthma and recurring wheezing, undergoing probiotic treatment with Bifiasthm with the aim of assessing the reduction in asthma attacks.

Detailed Description

Allergic disorders have dramatically increased in prevalence over the past decade, particularly in developed countries, and primary prevention of allergic disease has proved an elusive goal. There is increasing evidence that the airway microbiome influences the development of wheezing and childhood asthma. Probiotics are increasingly considered as a promising treatment for the correction of dysbiosis, reduction of systemic inflammation, and modulation of allergic diseases. The aim of this study is, therefore, to evaluate the efficacy of Bifidobacterium breve B632 (DSM 24706) and Lactobacillus salivarius LS01 (DSM 22775) in the prevention of asthmatic allergies in human subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma in Children

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled double-blind trial

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

probiotic treatment

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo treatment

Arm Type

Placebo Comparator

Arm Description

For the first 8 weeks was administered 1 sachet in the morning and 1 in the evening, for the last 8 weeks was administered 1 sachet per day Maltodextrin and silicon dioxide

Intervention Type

Dietary Supplement

Intervention Name(s)

Bifiasthm

Intervention Description

Subjects will be instructed to take an active or placebo sachet twice daily for eight weeks, and subsequent intake of one dose daily for a further eight weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Reduction in Asthma episodes

Description

Reduction in the frequency and severity of asthma crises, the evaluation is performed using Guidelines for management of Asthma, Italian Society of Pediatricians

Time Frame

12 months

Title

Reduction in wheezing

Description

Reduction in the frequency of wheezing episodes, numerical evaluation.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Reduction of adminstrated drug quantity

Description

Reduction in the administered drug quantity for asthma crisis treatment

Time Frame

12 months

Title

Reduction in treatment time

Description

use of short-term treatments

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The study will include all children aged 6 to 14, with slight and moderate persistent asthma according to GINA 2015 criteria (asthma classification did not change in GINA 2015 and 2016 guidelines), whether or not showing positive skin allergometric tests, as well as all children aged 2 yrs, 364 days to 5 years, 364 days, with recurring wheezing, whether or not diagnosed with asthma (positive and/or negative prick). Exclusion Criteria: Severe persistent asthma Known congenital or acquired immunodeficiencies Cystic fibrosis Chronic pulmonary diseases (bronchodysplasia) Age < 1 yr, 364d and 14 yrs

Facility Information:

Facility Name

Primary Care Ambulatory

City

Pozzuoli

State/Province

Naples

ZIP/Postal Code

80078

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

35487387

Citation

Ciprandi G, Schiavetti I, Cioffi L, Pane M, Drago L. The Probiotics in Pediatric Asthma Management (PROPAM) study: A Post Hoc analysis in allergic children. Ann Allergy Asthma Immunol. 2022 Jul;129(1):111-113. doi: 10.1016/j.anai.2022.04.026. Epub 2022 Apr 26. No abstract available.

Results Reference

derived

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