Effect of Secretin in Functional Dyspepsia and Healthy Subjects

What Was Tested

This registered phase 1, phase 2 trial tested Secretin.

The dominant site of synthesis and secretion of this hormone are enteroendocrine S cells in the duodenum.

Inflammation-induced damage to these cells could produce a deficiency.

It had four arms (groups): Healthy Controls: Secretin Then Placebo (experimental), Healthy Controls: Placebo Then Secretin (experimental), Functional Dyspepsia: Secretin Then Placebo (experimental) and Functional Dyspepsia: Placebo Then Secretin (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Able to provide written informed consent prior to any study procedures and be willing and able to comply with study procedures. Body mass index of 18-35 kg/m2.

The full record lists 4 inclusion and 15 exclusion criteria; among the exclusions: unable or unwilling to provide informed consent or to comply with study procedures; unable to avoid the following over-the-counter medications 48 hours prior to the baseline period and throughout the study:; medications that alter gi transit or motor function including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin, buspirone, clonidine, tricyclic antidepressants, and secretin-norepinephrine reuptake inhibitors.

How the Study Was Run

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

Because people in this Secretin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Secretin and the comparison at some point, usually with a gap in between.

As a double-blind Secretin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2018-11-07 with completion listed for 2019-07-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Maximum Satiation (time frame: 60 minutes). Fasting Gastric Volume (time frame: Baseline). Postprandial Volume (time frame: 15 minutes).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Secretin in 20 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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