Clinical Trials Logo

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02695784
Study type Interventional
Source Newcastle-upon-Tyne Hospitals NHS Trust
Contact Janet Berrington, MBBS MD
Phone 01912825197
Email janet.Berrington@nuth.nhs.uk
Status Recruiting
Phase Phase 4
Start date September 1, 2017
Completion date September 1, 2019

See also
  Status Clinical Trial Phase
Withdrawn NCT03239197 - Project SHARE (motherS Have All the Right microbEs) N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Recruiting NCT06144905 - Norwegian Microbiota Study in Anorexia Nervosa
Completed NCT05864352 - The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
Recruiting NCT04138979 - Intestinal Microbiota of Breast Cancer Patients Undergoing Chemotherapy
Recruiting NCT04132713 - Study on Skin Microbiome of HFS
Completed NCT05726435 - Effects of Soluble Dietary Fiber on Sport Efficiency and Fatigue Delay in Top Basketball Players N/A
Completed NCT03543891 - Intestinal Microbiota and Thyroid Cancer
Completed NCT05242913 - Effects of Resistant Potato Starch on the Gut Microbiota N/A
Recruiting NCT04200521 - The Effect of Bariatric Procedures on Gut Microbiota in Obese Individuals in United Arab Emirates and Lebanon
Recruiting NCT05891977 - Effect of Tomato Paste Consumption on the Microbiota-gut-brain Axis in Healthy Adults N/A
Completed NCT02988349 - Ecological Effect of Arginine Dentifrice on Oral Microbiota N/A
Completed NCT05352724 - Clinical Trial to Evaluate the Efficacy of a Sport Drink After High-intensity Aerobic Exercise N/A
Completed NCT04674839 - The Impact of MS-20 on Gut Microbiota Composition in Adult Individuals N/A
Completed NCT03754504 - Effects of Cranberry Powder Supplements on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT05394948 - Circular Economy and the Design of Healthy and Sustainable Food and Ingredients N/A
Terminated NCT03752372 - Microbiome Alterations in IL10RA-deficient Patients After HSCT
Completed NCT05974124 - Effectiveness of Ophthalmic Antiseptic Preparations N/A
Recruiting NCT02005003 - Cognitive and Metabolic Effects of a Probiotic Supplement N/A
Completed NCT04324749 - Healthy Prebiotic and Postbiotic Effects of Peanuts and Peanut Butter: College Intervention Trial N/A