RecruitingPhase 3NCT05063149

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.


Sponsor

Franciscus Gasthuis

Enrollment

500 participants

Start Date

Jan 18, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 WeeksMax Age: 10 Weeks

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Broncho-Vaxom and Placebo for people with lrti, premature, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 6 Weeks to 10 Weeks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBroncho-Vaxom

Broncho-Vaxom is a bacterial extract comprising lyophilised fractions of 21 different inactivated bacterial strains, which are frequently causing RTI.

OTHERPlacebo

Placebo powder from a capsule will be given, which will be indistinguishable from the active study drug.


Locations(1)

Franciscus Gasthuis & Vlietland

Rotterdam, South Holland, Netherlands

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NCT05063149


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