Effect of single versus multi-strain probiotic supplementation on the time to full enteral feeds in preterm neonates – a double blind randomised controlled trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000940572

Acronym

SiMPro Study (Single or Multiple Probiotics for neonates)

Enrollment

172

Registered

2015-09-08

Start date

2015-09-02

Completion date

2017-05-16

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Probiotics are live micro-organisms which, when administered in adequate amounts, confer a health benefit on the host. Probiotics have been proven to reduce necrotizing enterocolitis, a devastating and life threatening emergency in neonates. Over recent years, the role of probiotics in improving gut motility and function has emerged. Probiotics, especially specific strains could improve nutrition in neonates by improving tolerance of oral feeds. Intolerance or poor tolerance of feeds along with repeated infections are some of the factors contributing to malnutrition in these high risk infants. Prevention of nutrition related issues in newborns will improve their long term development as well as their growth. We propose to compare single strain probiotic as compared to multiple strain probiotic for their ability to improve oral feed tolerance in neonates. We will be administering either the single strain or multi strain probiotic after allotting the infant into either one or the other group and then examine the baby’s stool for presence of these good bacteria (contained in the probiotic). We will also be looking at the complex genetic structure of the bacteria in stool and study if probiotics could change the bad bacteria to good beneficial ones. We will enrol all newborns less than 28 weeks of gestation, after parental consent. The probiotic supplements will be administered to the baby after starting oral feeds and continued till the baby is near term (37 weeks of gestation). Since probiotics improve intestinal motility, we will be investigating whether multiple strain probiotic will improve it to a better extent as compared to single strain probiotic. We will administer a small amount of dye orally to the infant and observe its excretion into stools. The better the effect on gut motility, the faster will be the excretion and shorter will be the time to excrete the dye as well. In summary, this project will help us to conclude whether multiple strain probiotic will be more beneficial as compared to single strain for routine use in this high risk population.

Interventions

Intervention: Mixture of 3 strains (B. breve M-16V, B. longum subsp. infantis M-63 and B. longum subsp. longum BB536 (1 billion CFU of each strain per 1 g sachet: 3-strains group) Frequency of administration: 1 sachet per day when on minimal enteral feed, 2 sachets per day when > 50 ml/kg/day enteral feeds. Duration of administration: From commencement of enteral feeds till 37 completed weeks of gestation Mode of administration: reconstituted with breast milk, so oral liquid

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

7 Days to 10 Weeks

Healthy volunteers

Inclusion criteria

(1) Gestation <28 weeks at birth (2) ready to commence on milk feeds or on milk feeds for <12 hours (3) Informed parental consent

Exclusion criteria

(1) Congenital malformations (2) Chromosomal aberrations (3) Not ready for feeds or on feeds for > 12 hours

Outcome results