NCT02736734|CompletedPhase 4
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Sponsor study identifier
interventional
14
1 country
1
Study Start
October 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2014
Date type not reportedThis date has not been verified as actual or estimated.
December 2014
Actual (reported)December 2014
Actual (reported)December 10, 2015
Actual (reported)April 13, 2016
Actual (reported)Changes in esophageal contractile properties after Intravenous CRH administration in Healthy Volunteers
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.
approximately 2 hours study period, effect of CRH will be evaluated 30 minutes after the administration
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Targid, KU Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Jan F Tack, MD, PhD
KU Leuven
14 participants (actual enrollment reported by the registry).
First Submitted
December 10, 2015
First Posted
April 13, 2016
Study Start
October 2014
Date type not reportedThis date has not been verified as actual or estimated.
Prevalence and Clinical Characteristics of Patients With Jackhammer Esophagus and Symptoms of Gastroesophageal Reflux Disease
Contact the study team to confirm eligibility.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
April 13, 2016
Record last verified: 2016-04
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Source: ClinicalTrials.gov.
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