Probiotics After Discharge

NCT02695784 | Unknown Phase 4

• 1 other identifier: 7840
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbiota; Bacteriophages; Infantile Colic; Growth

Outcome Measures

Primary Outcomes (1)

• Microbiome

  16S RNA assessed using illumina sequencer

  one year

Secondary Outcomes (3)

• Growth Velocity

  1 year

• Head Growth

  1 year

• Growth: Length

  1 year

Study Arms (2)

Probiotic continuation

EXPERIMENTAL

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

Dietary Supplement: Probiotic Continuation

Standard treatment Group

NO INTERVENTION

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

Interventions

Probiotic Continuation DIETARY_SUPPLEMENT

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

Probiotic continuation

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead
• Northumbria University: collaborator

Study Sites (1)

Newcastle Neonatal Service

Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Janet Berrington

  Newcastle NHS FOundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janet Berrington, MBBS MD

CONTACT

01912825197; janet.Berrington@nuth.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 1, 2016
• Study Start: September 1, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: December 27, 2017

Record last verified: 2017-12

Locations

GB (1)