BLIPA - Bacterial Lysate in Preventing Asthma

• Research type

  Research Study

• Full title

  Oral bacterial lysate to prevent persistent wheeze in infants after severe bronchiolitis; a randomised placebo-controlled trial

• IRAS ID

  1004156

• Contact name

  Jonathan Grigg

• Contact email

  j.grigg@qmul.ac.uk

• Sponsor organisation

  Queen Mary University of London

• Eudract number

  2021-000628-36

• Clinicaltrials.gov Identifier

  NCT05064631

• Research summary

  Bronchiolitis is a common viral infection of the small airways of infants and some affected infants will require hospital
  admission. Severe bronchiolitis is a marker for greatly increased risk of developing both preschool wheeze and
  subsequent school age asthma. Since epidemiological studies suggest that exposure to microbial products protects
  against preschool wheeze, lysates of bacteria may prevent the development of wheeze after bronchiolitis, with long term
  beneficial consequences.
  BLIPA is a phase IIb, randomised, double blind, placebo-controlled study, investigating the efficacy superiority of
  bacterial lysate capsules over placebo, in reducing wheeze in infants after severe bronchiolitis. The primary end point
  of the study is parent-reported, healthcare-professional confirmed wheeze at 19-24 months. The study aims to test
  bacterial lysate capsules (3.5mg over 24 months) for safety, efficacy, and to advance mechanistic understanding of its
  action.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  21/LO/0729

• Date of REC Opinion

  15 Nov 2021

• REC opinion

  Favourable Opinion