Establishing the role gut bacteria play in promoting intestinal rehabilitation amongst children with early onset short bowel syndrome

Not Applicable

Conditions: Digestive System
Children with early onset short bowel syndrome

Registration Number: ISRCTN90620576

Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 48

Inclusion Criteria

Group 1: Prospective recruitment of infants born within the study period from 4 weeks post-term with parenteral nutrition-dependent intestinal failure due to short bowel syndrome
Group 2: Any child already on parenteral nutrition and meets criteria for group 1 in the year before the study commences
Group 3: Children who had short bowel syndrome but have successfully achieved intestinal rehabilitation in the year before the study commences

Exclusion Criteria

Informed consent not provided

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut bacterial structural and functional profile in routinely collected stool samples in relation to intestinal rehabilitation measured using genetic sequencing techniques (16S rRNA sequencing and shotgun metagenomic sequencing) approximately every 3 months

Secondary Outcome Measures

Name	Time	Method
1. Achieving intestinal rehabilitation (weaning off parenteral nutrition (PN) to full enteral feeds for >28 days) <br>2. Proportion of PN as total nutritional intake measured as a percentage (based on Kcal/kg/day PN as a proportion of daily estimated energy intake) using information obtained from patient medical records at routine PN clinical team reviews at 3 monthly intervals<br>3. Presence of adverse PN-associated clinical outcomes (culture-confirmed central line-associated bloodstream infection, intestinal failure associated liver disease, catheter-related thrombosis), obtained from patient medical records at 3 monthly intervals <br>4. Quality of life measured using the Pediatric Quality of Life (PedsQL) questionnaire after recruitment (baseline) and at the end of the study period