RecruitingNot ApplicableInterventional

A randomised, double-blind, parallel group, placebo controlled, trial of Bactek for the prevention of lower respiratory tract infections in preterm infants

Babies born very early—at or before 29 weeks and 6 days—often have delicate, developing lungs. More than half will suffer from chest infections during their first year, which can cause wheezing and breathing problems. Currently, doctors have very few treatments to prevent these infections. The BALLOON study tests an oral spray called Bactek (MV-130). Bactek contains harmless, inactive bacteria that act like a gentle vaccine to help train a baby's immune system to fight off chest bugs. In this trial, babies are randomly chosen to receive either Bactek or an identical dummy spray (placebo) once a day for a year, starting around their original due date. Researchers want to see if the spray safely reduces chest infections, GP visits, and hospital stays. The trial is run by Cardiff University and funded by the National Institute for Health and Care Research (NIHR).

At a glance

Status

Recruiting

Phase

Not Applicable

Sponsor

Cardiff University

Enrolment target

542

Start

17 Feb 2025

Estimated completion

31 Dec 2026

Respiratory outcomes after premature birth including lower respiratory tract infections and wheeze.

What is this study about?

Babies born before 30 weeks enter the world with lungs that are not fully developed. Many need support with breathing in the neonatal unit. Even after coming home, more than half of these infants develop chest infections. These infections can damage fragile lungs, leading to long-term wheezing, regular visits to the GP, and distressing stays in hospital.

At the moment, there are very few treatments that stop chest infections before they start. The BALLOON study is looking at a new way to protect these babies. The researchers are testing an oral mouth spray called Bactek (MV-130). It contains inactive, harmless bacteria. Instead of acting like an antibiotic that kills active germs, it acts like a vaccine. It helps 'train' the baby's developing immune system so it is ready to fight off bugs naturally.

Bactek has already been tested safely in older children and infants, showing promising reductions in chest infections and wheeze. This trial will involve 542 premature babies across the UK to see if it provides the same vital protection for those born earliest. If successful, this simple daily spray could keep more premature babies out of hospital and give their lungs the best possible start in life.

Key takeaways

Tests an oral bacterial spray designed to train the immune system against chest infections.
Open to premature babies born at or before 29 weeks and 6 days.
Babies take a simple daily mouth spray from near their due date for 12 months.
Half of babies receive the active spray, and half receive a dummy (placebo) spray.
Aims to reduce GP visits, wheezing, and emergency hospital admissions.

Who may be eligible?

This trial is designed for babies who were born very early—specifically at 29 weeks and 6 days of pregnancy or sooner. It includes single babies as well as twins or triplets. To take part, doctors must expect the baby to do well over their first year, and the family must be able to attend clinic visits.

Many premature babies experience health bumps along the way. Your baby can still join if they have common conditions linked to premature birth. This includes chronic lung disease of prematurity (bronchopulmonary dysplasia), going home on extra oxygen, having a feeding tube, or having had successful treatment for common newborn heart or tummy issues.

Babies cannot take part if they have major heart defects, serious inherited physical conditions, or severe immune system disorders. They also cannot take part if they are enrolled in another trial that conflicts with this one.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

My baby was born at 29 weeks and 6 days of pregnancy or earlier.
My baby is approaching their original due date (around 37 weeks corrected age).
My baby does not have a major heart defect or severe immune disorder.
My baby is expected to thrive over their first year of life.
We are able to attend regular follow-up visits and give the spray daily.

Answer every question to see your result.

What does participation involve?

If you decide to take part, your baby will be placed into one of two groups by chance. One group receives the Bactek spray, and the other receives a matching dummy spray (placebo) that contains no active ingredients. Neither you nor your research doctors will know which spray your baby is receiving. Treatment involves one quick spray into your baby's mouth every day. This starts around the time they reach 37 weeks (near their original due date) and continues until they are one year past their due date.

During this year, your baby will have regular reviews by the research team. The study involves gentle nose swabs and a painless breathing test while your baby is naturally asleep. A few small blood tests may also be needed, but the medical team will always try to combine these with your baby's routine blood tests so there are no extra needle pricks. You will also be asked to keep a record of any coughs, colds, GP visits, or hospital stays.

Potential risks and benefits

Your baby may not benefit directly, because they might receive the dummy spray instead of Bactek. However, if Bactek works, it could significantly cut down your baby's risk of chest infections. Bactek has been shown to be safe in other studies with young children, but minor side effects are always possible. Swabs can cause brief fussiness, and blood tests may cause minor bruising, though staff are specially trained to make these as quick and gentle as possible. Research staff will monitor your baby very closely and provide you with an emergency 24-hour contact card. Taking part is completely up to you, and you can withdraw at any time without your child's NHS care being affected.

Locations (27)

University Hospital of Wales
Approximate
Cardiff, Wales
Royal Victoria Infirmary
Approximate
Newcastle upon Tyne, England
Hull Royal Infirmary
Approximate
Hull, England
Southmead Hospital
Approximate
Bristol, England
Medway Maritime Hospital
Approximate
Gillingham, England
Queen Alexandra Hospital
Unverified
Portsmouth, England
Royal Preston Hospital
Unverified
Preston, England
Arrowe Park Hospital
Unverified
Wirral, England
Leicester Royal Infirmary
Unverified
Leicester, England
Royal Sussex County Hospital
Unverified
Brighton, England
St Richards Hospital
Unverified
Chichester, England
John Radcliffe Hospital
Unverified
Oxford, England

Common questions

What is in the Bactek spray?

Bactek contains common bacteria that have been safely killed and heat-treated. Because the bacteria are inactive, they cannot cause an infection, but they still teach the immune system how to recognize and fight off germs.

Will taking part interfere with my baby's routine NHS vaccines?

No. Your baby should still receive all their standard childhood immunisations on schedule. The study spray is designed to work alongside routine NHS vaccines.

Can I choose whether my baby gets the real medicine or the placebo?

No. A computer assigns babies at random. This gives every baby an equal chance of receiving Bactek or the dummy spray, which is the fairest way to prove if the treatment truly works.

What happens if my baby becomes unwell during the trial?

You will be given a 24-hour emergency contact card for the study team. You can take your baby to the GP or hospital as normal at any time, and you should let the doctors know your baby is in the study.

Does it cost anything to participate?

No. The trial treatment, extra check-ups, and all study supplies are provided completely free of charge through the NHS and the research grant.

How to find out more

Sailesh Kotecha

kotechas@cardiff.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.