SiMPro stands for Single vs. Multiple Probiotic Supplementation Study in preterm very low birth weight infants.
This clinical trial is examining the effects of a single strain versus multiple strain probiotic supplement for preterm infants.
Probiotics are live beneficial microorganisms (bacteria) that live in our guts naturally. They promote health by suppressing the growth of potentially harmful bacteria, improving immune system function, and enhancing the protective barrier of the gut. Humans consume these bacteria on a regular basis and have been doing so for hundreds of years, for example by eating yoghurt.
Preterm babies have immature digestive systems and can therefore have difficulties with feeding. They are also prone to a condition called NEC (necrotizing enterocolitis) which can lead to surgery or even death in severe cases.
We know that probiotic supplementation can reduce the risk of NEC by 50-60% and so we now routinely supplement all premature babies weighing less than 1,500g or born less than 33 weeks gestational age with probiotics. At King Edward Memorial Hospital we have been doing this for two years with over 1,000 babies, and have seen significant reduction in NEC.
Also, undernutrition in the first three months of life may contribute to poorer outcomes and growth and also increases the risk of developing metabolic syndrome in later life. We now also know that probiotics improve nutrition by improving feeding and decreasing hospital stay. Hence, probiotics have the potential to improve long term outcomes by improving nutrition in this critical period of life in preterm babies.
The probiotic that we use is a single strain (one type of bacteria), however small studies from other researchers have shown that there may be more benefits from using a multiple strain probiotic with three types of bacteria. This study will examine the effects of single vs multiple strain probiotics on outcomes in very preterm infants.
In this study we will give extremely preterm babies (born at less than 28 weeks gestation) a probiotic supplement with either a single bacteria or three different types of bacteria. Then we will:
- Measure how long it takes for babies in each group to progress to feeding only on milk
- Analyse the amount of probiotic bacteria in stools before any supplement is given, versus three weeks after beginning the daily supplementation to determine if the bacteria are colonising the gut
- Check levels of short chain fatty acids (which are produced by the probiotic bacteria) in the stool before any supplement is given, versus three weeks after beginning the daily supplementation, which indicates the levels of gut colonisation
We will also compare the degree of gut colonisation with sugars in breast milk, to see if there is a correlation between the two. If we do see a relationship, we may be able to develop a probiotic supplement with added sugars in the future, to enhance the protective effects of probiotics.
This study is funded by grants from Telethon and the Princess Margaret Hospital Foundation.