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Probiotics After Discharge

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02695784
Acronym
PAD
Enrollment
40
Registered
2016-03-01
Start date
2017-09-01
Completion date
2019-09-01
Last updated
2017-12-27

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

Conditions

Bacteriophages, Growth, Infantile Colic, Microbiota

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTProbiotic Continuation

This arm will continue to receive probiotics beyond 34 weeks corrected gestation until two months after discharge

Sponsors

Northumbria University
CollaboratorOTHER
Newcastle-upon-Tyne Hospitals NHS Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 32 Weeks
Healthy volunteers
No

Inclusion criteria

* \<32 weeks Corrected Gestation * Followed up in Newcastle Region

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Microbiomeone year16S RNA assessed using illumina sequencer

Secondary

MeasureTime frameDescription
Growth Velocity1 yearWeight Increase in g/kg/day
Head Growth1 yearcm/kg/day
Growth: Length1 yearLength: cm/kg/day

Countries

United Kingdom

Contacts

Primary ContactJanet Berrington, MBBS MD
janet.Berrington@nuth.nhs.uk01912825197

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026