Short Bowel Syndrome (SBS)NCT07400783
TED_ORG: Study on Short Bowel Syndrome
A study testing Teduglutide (ALX-0600) and No Treatment Added in people with Short Bowel Syndrome (SBS), run by Meyer Children's Hospital IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 months to 17 years
- Conditions the study is for
- Short Bowel Syndrome (SBS)
- What is being tested?
- Teduglutide (ALX-0600) and No Treatment Added
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 30 Oct 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Adult patients (≥ 18 years old);
- Patients who have never undergone intestinal resective surgery
- Current or past use of teduglutide
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Aou Meyer IRCSS
Florence, Florence
Antonino Morabito, +390555662545, antonino.morabito@meyer.it
About this study
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
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.
Read more
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.
- Conditions
- Short Bowel Syndrome (SBS)
- Being tested
- Teduglutide (ALX-0600), No Treatment Added
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 AddedOther
No Treatment Added
| Study group | Role | What they receive |
|---|---|---|
| teduglutide-treated organoids | Other | Human intestinal organoids derived from pediatric patients with short bowel syndrome are treated in vitro with teduglutide to assess its effects on intestinal morphology, gene and protein expression, and nutrient absorption. Receives: Drug: Teduglutide (ALX-0600) |
| Untreated organoids | Other | Human intestinal organoids derived from pediatric patients with short bowel syndrome are maintained in vitro without exposure to teduglutide and serve as a control group for comparison. Receives: Other: No Treatment Added |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal organoid diameter after in vitro exposure to teduglutide
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.
Measured: During in vitro treatment period (up to 7 days)
Crypt-villus-like architecture in intestinal organoids
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.
Measured: During in vitro treatment period (up to 7 days)
Organoid shape (sphericity) after in vitro teduglutide treatment
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.
Measured: During in vitro treatment period (up to 7 days)
Lumen size in intestinal organoids after in vitro exposure to teduglutide
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.
Measured: During in vitro treatment period (up to 7 days)
Intestinal organoid volume after in vitro exposure to teduglutide
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.
Measured: During in vitro treatment period (up to 7 days)
Lumen integrity in intestinal organoids after in vitro exposure to teduglutide
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.
Measured: During in vitro treatment period (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start30 Oct 2024
- Primary completionMar 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel Syndrome (SBS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonino Morabito, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400783
- Sponsor's protocol ID
- TED_ORG
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07400783
- Acronym / sponsor ID
- TED_ORG
- Conditions
- Short Bowel Syndrome (SBS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| teduglutide-treated organoids | Other | Drug: Teduglutide (ALX-0600)Human intestinal organoids derived from pediatric patients with short bowel syndrome are treated in vitro with teduglutide to assess its effects on intestinal morphology, gene and protein expression, and nutrient absorption. |
| Untreated organoids | Other | Other: No Treatment AddedHuman intestinal organoids derived from pediatric patients with short bowel syndrome are maintained in vitro without exposure to teduglutide and serve as a control group for comparison. |
Who may qualify
- Ages
- 4 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Adult patients (≥ 18 years old);
- Patients who have never undergone intestinal resective surgery
- Current or past use of teduglutide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teduglutide (ALX-0600)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. | Drug | teduglutide-treated organoids |
| No Treatment AddedNo Treatment Added | Other | Untreated organoids |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teduglutide (ALX-0600) and No Treatment Added in people with Short Bowel Syndrome (SBS), run by Meyer Children's Hospital IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal organoid diameter after in vitro exposure to teduglutide (time frame: During in vitro treatment period (up to 7 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.