Probiotics After Discharge (PAD)
Primary Purpose
Microbiota, Bacteriophages, Infantile Colic
Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Probiotic Continuation
Sponsored by
About this trial
This is an interventional basic science trial for Microbiota
Eligibility Criteria
Inclusion Criteria:
- <32 weeks Corrected Gestation
- Followed up in Newcastle Region
Exclusion Criteria:
-
Sites / Locations
- Newcastle Neonatal ServiceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Probiotic continuation
Standard treatment Group
Arm Description
This Group will Continue probiotics Beyond 34 weeks corrected Gestational agent standard practice
This group will continue current standard practice of stopping probiotics at 34 weeks corrected gestational age
Outcomes
Primary Outcome Measures
Microbiome
16S RNA assessed using illumina sequencer
Secondary Outcome Measures
Growth Velocity
Weight Increase in g/kg/day
Head Growth
cm/kg/day
Growth: Length
Length: cm/kg/day
Full Information
NCT ID
NCT02695784
First Posted
February 25, 2016
Last Updated
December 22, 2017
Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborators
Northumbria University
1. Study Identification
Unique Protocol Identification Number
NCT02695784
Brief Title
Probiotics After Discharge
Acronym
PAD
Official Title
Probiotics After Discharge (PAD) Study: Impact on Microbiome, Health and Growth Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
September 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborators
Northumbria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbiota, Bacteriophages, Infantile Colic, Growth
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotic continuation
Arm Type
Experimental
Arm Description
This Group will Continue probiotics Beyond 34 weeks corrected Gestational agent standard practice
Arm Title
Standard treatment Group
Arm Type
No Intervention
Arm Description
This group will continue current standard practice of stopping probiotics at 34 weeks corrected gestational age
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic Continuation
Intervention Description
This arm will continue to receive probiotics beyond 34 weeks corrected gestation until two months after discharge
Primary Outcome Measure Information:
Title
Microbiome
Description
16S RNA assessed using illumina sequencer
Time Frame
one year
Secondary Outcome Measure Information:
Title
Growth Velocity
Description
Weight Increase in g/kg/day
Time Frame
1 year
Title
Head Growth
Description
cm/kg/day
Time Frame
1 year
Title
Growth: Length
Description
Length: cm/kg/day
Time Frame
1 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
<32 weeks Corrected Gestation
Followed up in Newcastle Region
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janet Berrington, MBBS MD
Phone
01912825197
Email
janet.Berrington@nuth.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Berrington
Organizational Affiliation
Newcastle NHS FOundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Newcastle Neonatal Service
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet Berrington, MD
12. IPD Sharing Statement
Learn more about this trial
Probiotics After Discharge
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