Safety and Effectiveness of teduglutide (Revestive ®) treatment in paediatric patients with chronic intestinal failure due to short bowel syndrome – an observational study

Safety and Effectiveness of teduglutide (Revestive ®) treatment in paediatric patients with chronic intestinal failure due to short bowel syndrome – an observational study - TEDU-REG

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00021006

Enrollment

Registered

2020-03-17

Start date

2020-11-15

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K91.2

Interventions

Group 1: Treatment with Teduglutid

Eligibility

Sex/Gender

All

Age

1 Years to 18 Years

Inclusion criteria

Inclusion criteria: • Children 1 to 18 years of age receiving treatment with Revestive® in Germany and Austria according to the drug license • Signed informed consent from parents or legal representative

Exclusion criteria

Exclusion criteria: Missing signed consent and off-label use

Design outcomes

Primary

Measure	Time frame
• Reduction of parenteral nutrition - evaluate the efficacy of Revestive® application	—

Secondary

Measure	Time frame
Secondary objectives: • Impact on diarrhoea: Changes of stool output – number of stools per day and stool consistency • Impact on weight and growth development • Impact on vital parameters (blood pressure, heart frequency) • Impact on urine output • Impact on quality of life • Impact on pre-existing diseases/co-morbidities (e.g. intestinal failure associated liver disease) • Registration of treatment associated adverse events – evaluate long-term safety • Recording Revestive® treatment daily dosage, duration and causes for discontinuation Data aquisition will be assessed for each objective at start of treatment, 6 weeks, and every 6 months as well as at end of treatment and 6, 12 and 24 months thereafter.	—

Measure

Time frame

Secondary objectives: • Impact on diarrhoea: Changes of stool output – number of stools per day and stool consistency • Impact on weight and growth development • Impact on vital parameters (blood pressure, heart frequency) • Impact on urine output • Impact on quality of life • Impact on pre-existing diseases/co-morbidities (e.g. intestinal failure associated liver disease) • Registration of treatment associated adverse events – evaluate long-term safety • Recording Revestive® treatment daily dosage, duration and causes for discontinuation Data aquisition will be assessed for each objective at start of treatment, 6 weeks, and every 6 months as well as at end of treatment and 6, 12 and 24 months thereafter.

—

Countries

Austria, Germany

Contacts

Public ContactCarsten Posovszky

Klinik für Kinder- und Jugendmedizin

carsten.posovszky@uniklinik-ulm.de0731-50057470

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026