Probiotics After Discharge (PAD)

Newcastle-upon-Tyne Hospitals NHS Trust

Status and phase: Unknown; Phase 4

Conditions: Infantile Colic; Bacteriophages; Growth; Microbiota

Treatments: Dietary Supplement: Probiotic Continuation

Study type: Interventional

Funder types: Other

Identifiers

NCT02695784

7840

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 32 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Probiotic continuation

Experimental group

Description:

This Group will Continue probiotics Beyond 34 weeks corrected Gestational agent standard practice

Treatment:

Dietary Supplement: Probiotic Continuation

Standard treatment Group

No Intervention group

Description:

This group will continue current standard practice of stopping probiotics at 34 weeks corrected gestational age