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Probiotics in Paediatric Asthma Management (ProPAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04289441
Recruitment Status : Completed
First Posted : February 28, 2020
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Probiotical S.p.A.

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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 : April 21, 2017
Actual Primary Completion Date : April 21, 2019
Actual Study Completion Date : November 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Reduction in Asthma episodes [ Time Frame: 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)

  2. Reduction in wheezing [ Time Frame: 12 months ]
    Reduction in the frequency of wheezing episodes, numerical evaluation.


Secondary Outcome Measures :
  1. Reduction of adminstrated drug quantity [ Time Frame: 12 months ]
    Reduction in the administered drug quantity for asthma crisis treatment

  2. Reduction in basic treatment length [ Time Frame: 12 months ]
    Savings in the use of cortisone or other basic treatment drugs


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04289441


Locations
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Italy
Primary Care Ambulatory
Pozzuoli, Naples, Italy, 80078
Sponsors and Collaborators
Probiotical S.p.A.
More Information
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Responsible Party: Probiotical S.p.A.
ClinicalTrials.gov Identifier: NCT04289441    
Other Study ID Numbers: SCCE n.41486
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases