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Probiotics After Discharge

NCT ID: NCT02695784

Last Updated: 2017-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-09-01

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.

Detailed Description

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Conditions

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Microbiota Bacteriophages Infantile Colic Growth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Probiotic continuation

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

Group Type EXPERIMENTAL

Probiotic Continuation

Intervention Type DIETARY_SUPPLEMENT

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

Standard treatment Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Probiotic Continuation

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northumbria University

OTHER

Sponsor Role collaborator

Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janet Berrington

Role: PRINCIPAL_INVESTIGATOR

Newcastle NHS FOundation Trust

Locations

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Newcastle Neonatal Service

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Janet Berrington, MBBS MD

Role: CONTACT

Phone: 01912825197

Email: [email protected]

Facility Contacts

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Janet Berrington, MD

Role: primary

Other Identifiers

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7840

Identifier Type: -

Identifier Source: org_study_id