Observational Study of Teduglutide Treatment in Chinese Children and Teenagers Aged 1 to 17 With Short Bowel Syndrome Dependent on Parenteral Nutrition

What this Trial Is About

Short Bowel Syndrome SBS is a rare condition where a large part of the intestine is missing or has been removed, causing difficulty in absorbing enough food, water, and nutrients. This study focuses on children and teenagers with SBS who depend on parenteral support PS for more than 42 days to stay healthy. Researchers aim to learn how well teduglutide works to reduce the need for PS and to assess its safety in this group. The study includes three groups of participants those who completed a 24-week teduglutide treatment before joining the study, those who started treatment before the study but have not finished 24 weeks, and those who will begin treatment after enrolling. Data will be collected retrospectively for earlier treatments and prospectively for ongoing or future treatments, covering up to 48 weeks for new starters. No intervention is administered by the study itself as it is observational. Participants will have their medical records reviewed, and new data collected during the study period. Researchers will measure changes in weekly PS volume, growth parameters, nutrition support, and safety through lab tests, vital signs, and adverse events. The main outcome is the percentage of participants achieving at least a 20% reduction in weekly PS volume at 24 weeks. The study will continue until September 2027, with ongoing monitoring of health and treatment responses.

A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome