How teduglutide affects intestinal organoids from children with short bowel syndrome
Official title: Short Bowel Syndrome: Human Intestinal Organoids to Investigate the Different Efficacy of the GLP-2 Analogue Teduglutide in Pediatric Patients With Short Bowel Syndrome
Run by Meyer Children's Hospital IRCCS · NCT07400783 · Data updated 2026-11-12
This project will test whether teduglutide changes how lab-grown intestinal tissue from children with short bowel syndrome grows and absorbs nutrients to explain why some kids respond differently.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Months to 17 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 1 site (Florence, Florence) |
| Status | Recruiting |
| Started | October 30, 2024 |
| Main results expected | March 2026 |
| Study ends | October 2026 |
| Registry record updated | February 10, 2026 |
| Trial ID | NCT07400783 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 4 months to 18 years with short bowel syndrome who have undergone intestinal resective surgery, have not previously received teduglutide, and who (or whose guardian) can provide informed consent are eligible.
✕Probably not a fit
Adults, patients who have never had intestinal resection, or those with prior teduglutide exposure are excluded and would not benefit from participation in this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study obtains intestinal tissue from pediatric SBS patients (typically at the time of resection) and grows patient-derived intestinal organoids in the laboratory. Organoids will be treated with teduglutide or left untreated to compare effects on growth, cell composition, and markers of absorption. Molecular and functional assays will be used to identify pathways and biomarkers associated with different responses. Researchers will relate organoid results to patients' clinical histories to seek predictors of who benefits from teduglutide.
Why it matters
Potential benefit: If successful, this work could help predict which children are most likely to benefit from teduglutide and guide more personalized treatment to reduce dependence on parenteral nutrition.
How similar studies have gone: Teduglutide has previously been shown to improve absorption and reduce parenteral nutrition needs in SBS, but using patient-derived intestinal organoids to explain and predict variable responses is a relatively new approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients or His/her Parents/ legal guardian must provide informed consent before they can participate in the study. * Paediatric patients: Male and female patients aged ≥ 4 months old and ≤ 18 years; * SBS patient or patient undergoing intestinal resective surgery Exclusion Criteria: * Adult patients (≥ 18 years old); * Patients who have never undergone intestinal resective surgery * Current or past use of teduglutide
Where it's running
-
Aou Meyer IRCSS
Florence, Florence, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.