Probiotics After Discharge

Microbiota Clinical Trial

— PAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02695784
• Other study ID #: 7840
• Status: Recruiting
• Phase: Phase 4
• First received: February 25, 2016
• Last updated: December 22, 2017
• Start date: September 1, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: December 2017
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: Janet Berrington, MBBS MD
• Phone: 01912825197
• Email: janet.Berrington[@]nuth.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 32 Weeks

Eligibility

Inclusion Criteria:

• <32 weeks Corrected Gestation

• Followed up in Newcastle Region

Exclusion Criteria:

Related Conditions & MeSH terms

• Bacteriophages
• Colic
• Growth
• Infantile Colic
• Microbiota

Intervention

Dietary Supplement:
• Probiotic Continuation
This arm will continue to receive probiotics beyond 34 weeks corrected gestation until two months after discharge

Locations

Country	Name	City	State
United Kingdom	Newcastle Neonatal Service	Newcastle Upon Tyne	Tyne And Wear

Sponsors (2)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust	Northumbria University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiome	16S RNA assessed using illumina sequencer	one year
Secondary	Growth Velocity	Weight Increase in g/kg/day	1 year
Secondary	Head Growth	cm/kg/day	1 year
Secondary	Growth: Length	Length: cm/kg/day	1 year