Actively Recruiting
A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome
Led by Takeda · Updated on 2026-03-13
12
Participants Needed
4
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Short Bowel Syndrome (SBS) is a rare condition that happens when a large part of the bowel (also called intestine) is missing or has been removed because of illness or surgery. In children, SBS means that the intestine cannot absorb enough food, water and important part of food the body needs (called nutrients) because a big part of it has been removed, bypassed or did not develop normally at birth and the children need support through a vein (parenteral support or PS) for more than 42 days to stay healthy and keep their energy. SBS in children is defined mainly by how well the intestine works and how long the children need this support, not just by how long the intestine is. The main aim of the study is to learn how well the teduglutide works in children and teenagers with SBS and who need PS. Another aim is to find out how well teduglutide works for participants to lower the amount of PS needed. Also, the study wants to learn more about how safe teduglutide is in children and teenagers with SBS who need PS. The study will review data already existing in the medical records of participants as well as collect new data during the study.
CONDITIONS
Official Title
A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and adolescents aged 1 through 17 years at the start of the study.
- Documented diagnosis of Short Bowel Syndrome (SBS).
- Received or planned to receive teduglutide treatment for at least 24 weeks.
- Stable parenteral nutrition or intravenous support with minimal changes (10% or less) for at least 3 months before study start.
- Informed consent obtained from participants aged 8 to 17 and their guardians; consent from guardians for participants under 8 years old unless waived by Ethics Committee.
You will not qualify if you...
- Participants unable to increase oral or tube feeding.
- Bowel lengthening surgery (STEP or similar) within 3 months before study start.
- Untreated significant intestinal obstruction causing feeding intolerance and inability to reduce parenteral support.
- Significant obstruction seen on upper GI series within 6 months before study start.
- Use of octreotide or DPP-4 inhibitors within 3 months before study start.
- Active, severe, or unstable liver problems indicated by specific abnormal lab test results.
- Ongoing active or unstable kidney problems with low kidney function (eGFR below 50 mL/min/1.73 m2).
- Allergy to teduglutide or its ingredients.
- Body weight less than 10 kg at the start.
- Previous use of teduglutide or Glucagon-like Peptide-2 (GLP-2).
- Use of GLP-1 analog or human growth hormone within 3 months before study start.
- Any condition that puts the participant at undue risk, prevents study completion, or affects study results as judged by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Guangzhou Women And Children's Medical Center
Guangzhou, Guangdong, China, 510040
Not Yet Recruiting
2
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, China, 200062
Not Yet Recruiting
3
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200092
Actively Recruiting
4
Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310006
Not Yet Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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