How teduglutide affects intestinal organoids from children with short bowel syndrome
Short Bowel Syndrome: Human Intestinal Organoids to Investigate the Different Efficacy of the GLP-2 Analogue Teduglutide in Pediatric Patients With Short Bowel Syndrome
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 4 Months to 17 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 1 site (Florence, Florence) |
| Trial ID | NCT07400783 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Florence, Florence
- Aou Meyer IRCSS — Florence, Florence, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.