Probiotics After Discharge (PAD)

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

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.

Study Overview

• Status: Unknown
• Conditions: Growth; Infantile Colic; Microbiota; Bacteriophages
• Intervention / Treatment: Dietary supplement: Probiotic Continuation

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Janet Berrington, MBBS MD; Phone Number: 01912825197; Email: janet.Berrington@nuth.nhs.uk

Study Locations

• United Kingdom
  • Tyne And Wear
    • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE1 4LP
      • Recruiting
      • Newcastle Neonatal Service
      • Contact: Janet Berrington, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• <32 weeks Corrected Gestation
• Followed up in Newcastle Region

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
• Collaborators: Northumbria University
• Investigators: Principal Investigator: Janet Berrington, Newcastle NHS FOundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: February 25, 2016
• First Submitted That Met QC Criteria: February 29, 2016
• First Posted (Estimate): March 1, 2016

Study Record Updates

• Last Update Posted (Actual): December 27, 2017
• Last Update Submitted That Met QC Criteria: December 22, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic
• Other Study ID Numbers: 7840

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No