Trial · Interventional
CompletedPhase 4Registry dataEffect of CRH on Duodenal Markers and Gastric Sensorimotor Function
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 20 participants (actual)
- Sponsor
- Universitaire Ziekenhuizen KU Leuven · Other
- Design
- Randomized · Double masking
- Countries
1 country
Belgium
- Start
- 21 May 2021
- Primary completion
- 19 Dec 2022
- Completion
- 19 Dec 2022
- First posted
- 8 Oct 2021
- Last update posted
- 3 Jul 2024
- Conditions
- GI Motility Disorder
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Effect of CRH on Duodenal Markers and Gastric Sensorimotor Function
NCT0507178121 May 2021 to 19 Dec 2022
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Corticotropin-release hormoneDrug
- Corticotropin-release hormoneDrug
Arms2
Active comparator
Cortisol releasing hormone group
HVs will start with CRH infusion.
Placebo comparator
Placebo (sodium choride) group
HVs will start with NaCl 0.9% (placebo) infusion
Primary outcomes2
Outcomes the sponsor listed as primary.
The effect of corticotrophin release hormone (CRH) on duodenal mast cell count
Time frame · 2 hours after CRH/placebo
Registry description
Duodenal mast cells (c-kit) will be counted per mm2 via stained duodenal biopsy sections.
The effect of CRH on sensitivity to gastric distention (part 2)
Time frame · 30 minutes after CRH/placebo
Registry description
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.
Secondary outcomes(6)
The effect of CRH on duodenal eosinophilia
Time frame · 2 hours after CRH/placebo
Registry description
Duodenal eosinophils (H\&E) will be counted per mm2 via stained duodenal biopsy sections.
The effect of CRH on duodenal mucosal permeability
Time frame · 2 hours after CRH/placebo
Registry description
Duodenal mucosa permeability on duodenal biopsies using adapted mini-Ussing chambers
The effect of CRH on gastric emptying time
Time frame · 30 minutes after CRH/placebo
Registry description
Gastric emptying time in minutes t (1/2) will be measured by 13C-octanoic acid breath test.
The effect of CRH on gastric accommodation
Time frame · 30 minutes after CRH/placebo
Registry description
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.
The effect of CRH on gastroduodenal symptoms.
Time frame · Every 15 minutes during CRH/placebo infusion for 4 hours
Registry description
Assessments using Visual Analog Score for GI symptoms which including pain, nausea, bloating, vomiting.
The effect of CRH on salivary cortisol level
Time frame · Right before CRH/placebo injection, 15, 30, 60, 120 minutes after injection
Registry description
Salivary cortisol level in nmol/L during placebo or CRH infusion
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 55 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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