I-Hsuan Huang
Leuven, 3000, Belgium
NCT Number: NCT05071781
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 4
Leuven, 3000, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intravenous CRH (100 µg)
Time frame: 2 hours after CRH/placebo
Duodenal mast cells (c-kit) will be counted per mm2 via stained duodenal biopsy sections.
Time frame: 30 minutes after CRH/placebo
Visceral sensitivity will be measured by barostat. Discomfort threshold will be defined as the first level of pressure and the corresponding volume that provokes discomfort. Pressure thresholds will be expressed both as pressures relative to minimal distending pressure and as absolute pressures.
Time frame: 2 hours after CRH/placebo
Duodenal eosinophils (H&E) will be counted per mm2 via stained duodenal biopsy sections.
Time frame: 2 hours after CRH/placebo
Duodenal mucosa permeability on duodenal biopsies using adapted mini-Ussing chambers
Time frame: 30 minutes after CRH/placebo
Gastric emptying time in minutes t (1/2) will be measured by 13C-octanoic acid breath test.
Time frame: 30 minutes after CRH/placebo
Gastric accommodation will be measured by barostat. Accommodation to a meal will be expressed as the average increase in intragastric volume during the first 4 postprandial hours.
Time frame: Every 15 minutes during CRH/placebo infusion for 4 hours
Assessments using Visual Analog Score for GI symptoms which including pain, nausea, bloating, vomiting.
Time frame: Right before CRH/placebo injection, 15, 30, 60, 120 minutes after injection
Salivary cortisol level in nmol/L during placebo or CRH infusion
Universitaire Ziekenhuizen KU Leuven
Other
The Effect of Corticotropin Release Hormone on Duodenal Markers and Gastric Sensorimotor Function in Healthy Volunteers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.