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NCT Number: NCT07400783

TED_ORG: Study on Short Bowel Syndrome

The goal of this clinical trial is to understand why pediatric patients with short bowel syndrome respond differently to treatment with the glucagon-like peptide-2 (GLP-2) analogue teduglutide. Short bowel syndrome is a rare and severe condition in children that results from extensive intestinal resection and leads to impaired nutrient absorption, chronic diarrhea, and dependence on parenteral nutrition. Although teduglutide is known to promote intestinal adaptation and improve absorption, the clinical response varies widely among patients, and the biological mechanisms underlying this variability are not fully understood.

This study aims to investigate the effects of teduglutide using human intestinal organoids derived from intestinal tissue samples of pediatric patients with short bowel syndrome. Intestinal organoids are three-dimensional structures grown from patient-derived stem cells that reproduce key structural and functional characteristics of the human intestine. These organoids provide a human-based experimental model that allows the study of intestinal morphology, cellular behavior, and nutrient absorption in a controlled in vitro environment.

The main questions this study aims to answer are:

Does treatment with teduglutide improve the absorptive capacity of human intestinal organoids derived from pediatric patients with short bowel syndrome?

Are there differences in intestinal structure, cellular proliferation, and gene expression between teduglutide-treated organoids and untreated organoids?

Are specific molecular or cellular features associated with different responses to teduglutide?

Researchers will compare intestinal organoids treated with teduglutide to untreated organoids obtained from the same patients. This comparison will be used to evaluate changes in organoid morphology, expression of receptors involved in intestinal growth and absorption, activity of nutrient transporters, and overall absorptive function. The study will also explore differences between organoids derived from patients who show different clinical responses to teduglutide.

Participants in this study are pediatric patients with short bowel syndrome or patients undergoing intestinal resection surgery as part of their standard clinical care. No experimental treatment is administered directly to participants as part of this study. Intestinal tissue samples are collected only during clinically indicated surgical procedures and are not obtained specifically for research purposes.

Participants will:

Provide intestinal tissue samples collected during routine or clinically indicated intestinal surgery

Have intestinal organoids generated from their tissue samples using established laboratory techniques

Have their organoids studied in vitro with and without exposure to teduglutide to evaluate intestinal structure, gene and protein expression, and nutrient absorption mechanisms

The results of this study are expected to improve understanding of the biological mechanisms underlying variable responses to teduglutide and may contribute to the development of more personalized treatment strategies for pediatric patients with short bowel syndrome in the future.

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Key information

Conditions

Short Bowel Syndrome (SBS) Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Short Bowel Syndrome

Age range

4 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teduglutide (ALX-0600)

Drug

Teduglutide is a glucagon-like peptide-2 (GLP-2) analogue. In this study, teduglutide is used in vitro on human intestinal organoids derived from pediatric patients with short bowel syndrome. The intervention is applied only to organoid cultures and is not administered directly to study participants. Teduglutide-treated organoids are compared with untreated control organoids to evaluate differences in intestinal structure, gene and protein expression, and nutrient absorption.

No Treatment Added

Other

No Treatment Added

Primary outcomes

  1. Intestinal organoid diameter after in vitro exposure to teduglutide

    Time frame: During in vitro treatment period (up to 7 days)

    Quantitative measurement of intestinal organoid diameter assessed by image-based analysis in patient-derived human intestinal organoids treated in vitro with teduglutide and compared with untreated organoids from the same participant.

  2. Crypt-villus-like architecture in intestinal organoids

    Time frame: During in vitro treatment period (up to 7 days)

    Quantitative assessment of crypt-villus-like architectural features in patient-derived human intestinal organoids following in vitro exposure to teduglutide, evaluated by image-based morphological analysis and compared with untreated organoids from the same participant.

  3. Organoid shape (sphericity) after in vitro teduglutide treatment

    Time frame: During in vitro treatment period (up to 7 days)

    Quantitative measurement of organoid shape, expressed as sphericity index, in patient-derived human intestinal organoids treated in vitro with teduglutide and compared with untreated organoids from the same participant.

  4. Lumen size in intestinal organoids after in vitro exposure to teduglutide

    Time frame: During in vitro treatment period (up to 7 days)

    Quantitative measurement of lumen size assessed by image-based analysis in patient-derived human intestinal organoids treated in vitro with teduglutide and compared with untreated organoids from the same participant.

  5. Intestinal organoid volume after in vitro exposure to teduglutide

    Time frame: During in vitro treatment period (up to 7 days)

    Quantitative measurement of intestinal organoid volume assessed by image-based analysis in patient-derived human intestinal organoids treated in vitro with teduglutide and compared with untreated organoids from the same participant.

  6. Lumen integrity in intestinal organoids after in vitro exposure to teduglutide

    Time frame: During in vitro treatment period (up to 7 days)

    Quantitative assessment of lumen integrity assessed by image-based analysis in patient-derived human intestinal organoids treated in vitro with teduglutide and compared with untreated organoids from the same participant.

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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