Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics Revestive® in the Management of Short Bowel Syndrome Pediatric Patients

What Was Tested

The trial (phase 4) is built around Teduglutide (GLP-2 analog).

It had 1 arm (groups): Revestive (experimental).

The registry classes the interventions as drug.

More on the Plan

Teduglutide (Revestive®) is an analog of glucagon-like peptide 2 (GLP-2), a naturally occurring hormone that regulates the functional and structural integrity of the cells lining the gastrointestinal tract.

The rationale for the use of Revestive® is based on data obtained, especially in the trial in SBS patients.

Who Took Part

25 actual participants took part.

It was open to people of any sex aged from 2 years up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Being aged from 2 to 18 years old included ;. Being dependent on PN for at least 2 years and enterally fed (oral or tube feeding) ;. Having a normal colonoscopy in the 12 months before screening for children with maintained colon (=SBS type 2 or 3) older than 12 years ;. Having signed the Informed consent form (or parents or legal representative for minor patients).

The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: having a major gastrointestinal surgical intervention like serial transverse enteroplasty or any other bowel lengthening procedure performed within 6 months of screening ;; having an unstable absorption due to cystic fibrosis or known dna abnormalities ;; presenting a radiographic or manometric evidence of pseudo-obstruction or severe known dysmotility syndrome, including persistent, severe gastroschisis-related motility disorders ;.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Teduglutide (GLP-2 analog) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2018-07-02 with completion listed for 2019-12-11.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 15 secondary outcomes, for example Ostomy output defined as stool balance testing, urine output and plasma citrulline, Change in days per week of Parenteral Nutrition (PN), Change in number of stool per day, Change in stools consistency (Bristol stool chart), Ingesta (calorimetric measure) and Stool weight/24h.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Teduglutide (GLP-2 analog) in 25 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teduglutide (GLP-2 analog) compound page, all human trials.