Actively Recruiting

Phase Not Applicable
Age: 4Months - 17Years
All Genders
ID07400783

Short Bowel Syndrome: Human Intestinal Organoids to Investigate the Different Efficacy of the GLP-2 Analogue Teduglutide in Pediatric Patients

Led by Meyer Children's Hospital IRCCS · Updated on 2026-02-10

50

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying pediatric patients with short bowel syndrome, a rare condition where significant intestinal removal causes problems with nutrient absorption and reliance on parenteral nutrition. This trial aims to understand why children respond differently to teduglutide, a drug that helps the intestine adapt and absorb nutrients better. The study uses human intestinal organoids, which are lab-grown mini-intestines from patient tissue, to explore biological reasons behind varied treatment responses. The study compares organoids treated with teduglutide to untreated ones to assess changes in intestinal structure, cell growth, gene activity, and nutrient absorption. Organoids come from intestinal tissue collected during routine surgeries and are grown and treated in the lab. No experimental treatment is given directly to the children participating; the focus is on lab testing of their tissue samples. Participants provide tissue samples during standard surgical procedures, and their organoids are studied in vitro for up to seven days with and without teduglutide exposure. Researchers measure organoid size, shape, lumen size, architecture, and integrity to evaluate the drug's effects. This work aims to improve understanding of teduglutide's impact and support more personalized treatments for children with short bowel syndrome in the future.

CONDITIONS

Brief Title

TED_ORG: Study on Short Bowel Syndrome

Who Can Participate

Age: 4Months - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients or their parents/legal guardians must provide informed consent before participation
  • Pediatric patients aged 4 months to 18 years
  • Patients with short bowel syndrome or undergoing intestinal resective surgery
Not Eligible

You will not qualify if you...

  • Adults aged 18 years or older
  • Patients who have never undergone intestinal resective surgery
  • Current or past use of teduglutide treatment before the study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Sample Collection

Duration - Up to 7 days

Participants provide tissue samples which are used to create human intestinal organoids for laboratory testing.

1 visit for tissue collection

Laboratory Treatment and Assessment

Duration - Up to 7 days

Organoids derived from participants are treated in vitro with teduglutide or left untreated to study the effects on intestinal structure and function.

No participant visits; laboratory procedures only

Trial Site Locations

Total: 1 location

1

Aou Meyer IRCSS

Florence, Florence, Italy

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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