NCT04289441

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

January 23, 2020

Last Update Submit

January 25, 2023

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (2)

  • 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

    12 months

  • Reduction in wheezing

    Reduction in the frequency of wheezing episodes, numerical evaluation.

    12 months

Secondary Outcomes (2)

  • Reduction of adminstrated drug quantity

    12 months

  • Reduction in treatment time

    12 months

Study Arms (2)

probiotic treatment

ACTIVE COMPARATOR

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

Placebo treatment

PLACEBO COMPARATOR

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

Interventions

BifiasthmDIETARY_SUPPLEMENT

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.

probiotic treatment
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo treatment

Eligibility Criteria

Age1 Year - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Care Ambulatory

Pozzuoli, Naples, 80078, Italy

Location

Related Publications (1)

  • 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.

    PMID: 35487387DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled double-blind trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2020

First Posted

February 28, 2020

Study Start

April 21, 2017

Primary Completion

April 21, 2019

Study Completion

November 25, 2019

Last Updated

January 27, 2023

Record last verified: 2023-01

Locations

IT(1)