Effect of CRH on Duodenal Markers and Gastric Sensorimotor Function

What Was Tested

The trial (phase 4) is built around ACTH (Corticotropin).

In the present study, during Part 1, after a baseline gastroduodenoscopy, the investigators will perform a gastroduodenoscopy twice, to take duodenal biopsies before and 2 hours after administration of CRH/placebo.

The investigators will measure mucosal integrity and markers of immune activation as outlined in Parts A and B, and will use transmission electron microscopy to evaluate mast cell and eosinophil degranulation.

After an interval period of at least 1 week, CRH or placebo will be administrated again in a crossover fashion.

It had two arms (groups): Cortisol releasing hormone group (active comparator) and Placebo (sodium choride) group (placebo comparator).

HVs will start with CRH infusion.

The registry classes the interventions as drug.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Voluntary written informed consent of the participant has been obtained prior to any screening procedures. Subjects aged 18-55 years old (55y included). Male or female subjects. Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements.

The full record lists 6 inclusion and 22 exclusion criteria; among the exclusions: any disorder, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol; any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the trial; presence of a history of gastrointestinal surgery other than appendectomy.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

The participants were allocated by chance, so the ACTH (Corticotropin) group and the comparison group should start out alike.

Each person switched between ACTH (Corticotropin) and the comparison at some point, usually with a gap in between.

As a double-blind ACTH (Corticotropin) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2021-05-21 with completion listed for 2022-12-19.

It ran at 1 site in Belgium.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): The effect of corticotrophin release hormone (CRH) on duodenal mast cell count (time frame: 2 hours after CRH/placebo). The effect of CRH on sensitivity to gastric distention (part 2) (time frame: 30 minutes after CRH/placebo).

It also tracked 6 secondary outcomes, for example The effect of CRH on duodenal eosinophilia, The effect of CRH on duodenal mucosal permeability, The effect of CRH on gastric emptying time, The effect of CRH on gastric accommodation, The effect of CRH on gastroduodenal symptoms and The effect of CRH on salivary cortisol level.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in 20 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 ACTH (Corticotropin) compound page, all human trials.