Bacterial lysate treatment to prevent respiratory infections in preterm infants
Official title: Protecting Late-moderate Preterm Infants From Respiratory Tract Infections and Wheeze in Their First Years of Life by Using Bacterial Lysates.
Run by Franciscus Gasthuis · NCT05063149 · Data updated 2026-11-12
This study is testing if a bacterial treatment can help prevent respiratory infections and wheezing in preterm infants during their first year of life.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 6 Weeks to 10 Weeks |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Franciscus Gasthuis Academic / other |
| Locations | 1 site (Rotterdam, South Holland) |
| Status | Recruiting |
| Started | March 18, 2022 |
| Main results expected | December 2029 |
| Study ends | December 2030 |
| Registry record updated | September 25, 2026 |
| Trial ID | NCT05063149 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are moderate-late preterm infants born between 30 and 35 weeks of gestation who are otherwise healthy.
✕Probably not a fit
Patients with severe underlying respiratory diseases, significant cardiac issues, or those who have experienced lower respiratory tract infections prior to randomization may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study aims to reduce respiratory tract infections and wheezing in moderate-late preterm infants through the administration of bacterial lysates. A total of 500 otherwise healthy infants will be randomly assigned to receive either the bacterial lysate (OM-85/Broncho-Vaxom) or a placebo for ten days each month, starting from 6-10 weeks after birth until they reach 12 months. The study will also collect clinical data and biological samples to investigate immune maturation and microbiome development, with follow-up assessments at 6, 12, and potentially 24 months. The primary outcomes will focus on doctor-diagnosed lower respiratory tract infections and wheezing episodes during the first year of life.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of respiratory infections and wheezing in preterm infants, improving their overall health outcomes.
How similar studies have gone: While the approach of using bacterial lysates is promising, it is relatively novel in this specific population, and previous studies have shown mixed results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gestational age at delivery between 30+0 and 35+6 weeks * Postnatal age at least 6 weeks at randomization \& postmenstrual age at least 37 weeks * Written informed consent by both parents or formal caregivers Exclusion Criteria: * Underlying other severe respiratory disease such as broncho-pulmonary dysplasia (unexpected in this group); hemodynamic significant cardiac disease; immunodefi-ciency; severe failure to thrive; birth asphyxia with predicted poor neurological out-come; syndrome or serious congenital disorder. * Maternal TNF-alpha inhibitors or other immunosuppression during pregnancy and/or breastfeeding * Parents unable to speak and read Dutch/English language * Known allergic hypersensitivity to the active ingredients/substance or to any of the excipients.
Where it's running
-
Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, Netherlands Recruiting
Study contacts
- Study coordinator: Gerdien Tramper, MD PhD
- Email: proteastudie@franciscus.nl
- Phone: 0031 10 4617126
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.