The Effect of Corticotrophin-releasing Hormone (CRH) on Esophageal Motility in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT02736734|
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : April 13, 2016
Stress is well known to affect visceral sensitivity and gastrointestinal function in general. A majority of patients with gastroesophageal reflux disease (GERD) report stress as an important factor triggering symptom exacerbation. A real-life stressor could exacerbate heartburn symptoms in GERD patients by enhancing perceptual response to esophageal acid exposure. In Irritable Bowel Syndrome (IBS) patients, visceral hypersensitivity is a major pathophysiological mechanism and stress is shown to trigger or exacerbate symptoms.
A possible mechanism of stress−induced visceral sensitivity could be the barrier dysfunction. Indeed, in a study performed by our group, in human, an acute psychological stressor induces hyperpermeability in a mast cell dependent fashion and exogenous peripheral corticotrophin-releasing hormone (CRH) recapitulated its effects on barrier function. This increase in intestinal permeability is a phenomenon which appears as a prerequisite for visceral hypersensitivity. Furthermore, few studies indicate that human intestinal motility is probably modulated by CRH. It has been shown that the brain-gut axis in IBS patients has an exaggerated response to CRH.To our knowledge, the acute effect of exogenous CRH on esophageal motility has not been studied before.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Motility Disorders||Drug: CRH||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Corticotrophin-releasing Hormone (CRH) on Esophageal Motility in Healthy Volunteers|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
All HV first underwent a baseline manometry measurement. After 30 minutes, an intravenous CRH injection was done. The same measurement was repeated but now with CRH administered.
CRH injection: 100 µg CRH powder for injection (CRH Ferring) dissolved in 1ml NaCl 0.9%, administration intravenously over the course of 1 minute to avoid side effects.
Other Name: CRH, Ferring
- Changes in esophageal contractile properties after Intravenous CRH administration in Healthy Volunteers [ Time Frame: approximately 2 hours study period, effect of CRH will be evaluated 30 minutes after the administration ]The investigators will evaluate if the administration of intravenous CRH alters esophageal contractile properties. Esophageal contractile properties are measured by high resolution manometry (HRM). HRM measurements in the esophagus will be performed before and after CRH administration. The investigators will compare 3 HRM parameters (distal contractile integral (mmHg.s.cm), intrabolus pressure (mmHg), LES relaxation (mmHg)) before and after the administration of CRH and assess the number of HV in which these 3 parameters are altered after CRH administration to be able to report changes in contractile properties of the esophagus.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736734
|Targid, KU Leuven|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Principal Investigator:||Jan F Tack, MD, PhD||KU Leuven|