Probiotics After Discharge

Study Overview
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Brief Summary
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The influence of the preterm gut microbiota in health and disease has been well established. However, relatively little is known about how the microbiome changes after discharge and its relationship with growth, health and disease outcomes in the preterm population. This study aims to follow a cohort of preterm infants and explore the relationship of the later microbiome ('after discharge') with later growth and health outcomes in infancy. The study will also explore the effect of timing of stopping routinely administered probiotics on the post-discharge microbiome, infant feeding and outcomes such as colic. The investigators aim to longitudinally follow 40 infants born before 32 weeks gestation who have also taken part in the investigators microbiome study during their NICU stay (SERVIS REC No: 10/H0908/39) and where microbiomic sampling has been adequately achieved. The investigators will collect stool at and beyond the time of anticipated discharge (beyond 34 weeks) targeted to include pre- and post-weaning, and again at a year. Actual discharge timing of these infants varies, and is usually latest in the most immature infants, allowing an assessment of the influence of physical location (NICU vs home) as well as increasing age. Using 16S ribosomal RNA amplicon analysis, the investigators will assess bacterial colonisation of the gut and measure infant weight, length and head circumference at each time point. The investigators will use a parent questionnaire to assess daily crying time, parents' perceptions of colic severity using a visual analogue scale as well as vomiting and constipation for the two weeks before sampling.

Official Title
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Probiotics After Discharge (PAD) Study: Impact on Microbiome, Health and Growth Outcomes

Conditions
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Microbiota, Bacteriophages, Infantile Colic, Growth

Intervention / Treatment
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* Dietary Supplement: Probiotic Continuation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: <32 weeks Corrected Gestation Followed up in Newcastle Region Exclusion Criteria: -

Ages Eligible for Study
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Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic continuation<br>This Group will Continue probiotics Beyond 34 weeks corrected Gestational agent standard practice | Dietary Supplement: Probiotic Continuation<br>* This arm will continue to receive probiotics beyond 34 weeks corrected gestation until two months after discharge<br>|
| No Intervention: Standard treatment Group<br>This group will continue current standard practice of stopping probiotics at 34 weeks corrected gestational age | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome | 16S RNA assessed using illumina sequencer | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth Velocity | Weight Increase in g/kg/day | 1 year | 
| Head Growth | cm/kg/day | 1 year | 
| Growth: Length | Length: cm/kg/day | 1 year |