The Connection study
Research type
Research Study
Full title
A randomized, double blind, parallel-group, placebo controlled study to evaluate the efficacy and safety of IBP-9414 in premature infants 500-1500g birth weight in the prevention of necrotizing enterocolitis – The Connection study
IRAS ID
260519
Contact name
Heike Rabe
Contact email
Sponsor organisation
Infant Bacterial Therapeutics AB (IBT)
Eudract number
2018-000754-22
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Babies born too early (premature infants) can get a serious condition, called necrotising enterocolitis (NEC), which affects part of the bowels. It is the most common cause of illness of the bowels in premature infants during the first weeks of life.
NEC is a very serious condition can lead to death in up to half of affected infants. There is no way to predict which infant will get NEC, and there are no reliable early warning signals. There is no established way of preventing NEC.
In the first days of life of healthy, full-term infants, lactic acid bacteria spread rapidly throughout the bowels. These bacteria belong to the healthy pool of bacteria in the bowels.
In contrast, the spread of these bacteria is slower in the bowels of premature infants.
Infants with NEC are treated with stopping any oral feeds and giving antibiotics. Sometimes infants will need surgery where the affected bowel needs to be removed.
Researchers want to find out if a study medicine called “IBP-9414”, which is made of living healthy bacteria, can help prevent NEC in babies born too early.
The purpose of IBP-9414 treatment is to provide a source of lactic acid bacteria to premature infants. It is hoped that this will help them to make the bacterial environment of their bowels more like that of healthy, full-term infants.
It is planned that about 2158 premature infants will be in this study. They will be enrolled before they are 48 hours old.
The study will start with 300 infants whose birth weight is in the range of 750 to 1000g. About half of the infants will receive IBP-9414. The other half will receive sterile water (placebo). The researcher will compare both groups and find out whether the new treatment is better. The researchers and the clinical staff involved in the care of the babies will not know to which group an individual baby will have been allocated.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
19/LO/1436
Date of REC Opinion
14 Oct 2019
REC opinion
Further Information Favourable Opinion