ProPAM: Probiotics in Paediatric Asthma Management

Sponsor

Probiotical S.p.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT04289441

Collaborator

(none)

Enrollment

Location

Arms

31.1

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma in Children	Dietary Supplement: Bifiasthm Dietary Supplement: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled double-blind trialRandomized controlled double-blind trial

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 21, 2017

Actual Primary Completion Date :

Apr 21, 2019

Actual Study Completion Date :

Nov 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: probiotic treatment 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	Dietary Supplement: Bifiasthm 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.
Placebo Comparator: Placebo treatment 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	Dietary Supplement: Placebo Placebo

Arm

Intervention/Treatment

Active Comparator: probiotic treatment

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

Dietary Supplement: Bifiasthm

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.

Placebo Comparator: Placebo treatment

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

Dietary Supplement: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Reduction in Asthma episodes [12 months]
Reduction in the frequency and severity of asthma crises, the evaluation is performed using score by SIP 2016 (Guidelines for management of Asthma, Italian Society of Pediatricians)
Reduction in wheezing [12 months]
Reduction in the frequency of wheezing episodes, numerical evaluation.

Secondary Outcome Measures

Reduction of adminstrated drug quantity [12 months]
Reduction in the administered drug quantity for asthma crisis treatment
Reduction in basic treatment length [12 months]
Savings in the use of cortisone or other basic treatment drugs

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 14 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Primary Care Ambulatory	Pozzuoli	Naples	Italy	80078

Sponsors and Collaborators

Probiotical S.p.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Probiotical S.p.A.

ClinicalTrials.gov Identifier:

NCT04289441

Other Study ID Numbers:

SCCE n.41486

First Posted:

Feb 28, 2020

Last Update Posted:

Feb 28, 2020

Last Verified:

Apr 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Asthma

Study Results

No Results Posted as of Feb 28, 2020