Effect of CRH on Duodenal Markers and Gastric Sensorimotor Function
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
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.
As a complementary study, the investigators will also test the effect of ex vivo mast cell
blockade by lodoxamide to evaluate whether mast cells are involved in the hypothesized effect
of CRH on duodenal permeability.
In a second part of this study, Part 2, the investigators will perform a gastric barostat, to
measure the gastric accommodation and sensitivity to distension, and a carbon-13-octanoic
acid breath test to measure the gastric emptying time after administration of CRH/placebo.
Healthy volunteers will have the option to choose to which part of the study (part 1 or 2)
they wish to participate. They can also choose to cooperate to both study parts if preferred.