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

Gut microbiota and intestinal rehabilitation: a prospective childhood cohort longitudinal study of short bowel syndrome (The MIRACLS Study)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN90620576

Enrollment

Registered

2024-04-18

Start date

2022-12-01

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children with early onset short bowel syndrome Digestive System

Interventions

The proposed multi-centre prospective study will recruit children with early onset short bowel syndrome. Participants will be asked to provide non-invasive stool samples at 3 monthly intervals (for th

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Informed consent not provided

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Achieving intestinal rehabilitation (weaning off parenteral nutrition (PN) to full enteral feeds for >28 days) 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 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 4. Quality of life measured using the Pediatric Quality of Life (PedsQL) questionnaire after recruitment (baseline) and at the end of the study period	—

Measure

Time frame

1. Achieving intestinal rehabilitation (weaning off parenteral nutrition (PN) to full enteral feeds for >28 days) 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 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 4. Quality of life measured using the Pediatric Quality of Life (PedsQL) questionnaire after recruitment (baseline) and at the end of the study period

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Countries

England, United Kingdom

Contacts

Public ContactJemma Cleminson

jemma.cleminson@newcastle.ac.uk+44 (0)191 233 6161

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026