NCT05063149

Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.

Protecting Late-moderate Preterm Infants From Respiratory Tract Infections and Wheeze in Their First Years of Life by Using Bacterial Lysates.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Franciscus Gasthuis · Academic / Other
• Sex: All
• Age: 6 Weeks – 10 Weeks
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.

Detailed description

This is a randomised placebo-controlled trial including 500 otherwise healthy moderate-late preterm infants. Participants will receive bacterial lysate (OM-85/Broncho-Vaxom, 3,5mg) or placebo powder for ten days each month, from 6-10 weeks after birth until 12 months after birth. At 12 months, parents of participants are asked to join in Protea-2. If they do, participants in the treatment arm of year 1 are randomised again over placebo and OM-85 and treated until the age of 24 months. Clinical data will be continuously collected by e-Health and 3 (possibly digital) study visits; with optional biological sampling and lung function at baseline, 6 and 12 months. And in case of participation in Protea-2 also at 24 months. Main study parameters are doctor diagnosed lower RTI and wheezing episodes in the first year of life. Biological sampling will allow investigation of immune maturation, as well as microbiome development in the respiratory tract and gut. Also, biomarkers for risk-group selection and/or treatment success will be examined.

Conditions

• Wheezing
• LRTI
• Premature

Interventions

Type	Name	Description
DRUG	Broncho-Vaxom	Broncho-Vaxom is a bacterial extract comprising lyophilised fractions of 21 different inactivated bacterial strains, which are frequently causing RTI.
OTHER	Placebo	Placebo powder from a capsule will be given, which will be indistinguishable from the active study drug.

Timeline

• Start date: 2022-01-18
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2021-09-30
• Last updated: 2024-08-22

Locations

1 site across 1 country: Netherlands