Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study

What Was Tested

The trial (phase 3) is built around Lanreotide.

Nowadays, there are no recommendations nor national nor international for high output ileostomy treatment.

It had two arms (groups): lanreotide and anti-diarrheal treatments (experimental) and Current anti-diarrheal treatments alone (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 19 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Legal at the time of signing the agreement. Subject affiliated to the french social protection. Ileostomy has achieved since 10 days minimum at day 0 (D0: start of study treatment). Ileostomy output \> 1.5 liters / 24h for at least 24 hours at day 0. People able to understand the objectives, modalities and risks related to the study and give written informed consent.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: people with guardianship or with judicial protection; simultaneous participation in another biomedical research protocol involving a drug or topic exclusion period; pregnancy or breastfeeding.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Lanreotide group and the comparison group should start out alike.

The Lanreotide group and the comparison group ran side by side rather than switching.

Being open-label, the Lanreotide study did not mask who received what.

It started in 2015-10-22 with completion listed for 2017-12-31.

It ran at 6 sites in France (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of ileostomy bags used per day (time frame: 72 hours).

It also tracked 4 secondary outcomes, for example Number of ileostomy bags used per day, Blood urea and creatinine rates, Length of stay and Serious adverse events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Lanreotide in 19 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Lanreotide compound page, all human trials.