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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
Sponsor:
Information provided by (Responsible Party):
Prof Dr Jan Tack, Universitaire Ziekenhuizen Leuven

Brief Summary:

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

  Show Detailed Description

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
CRH condition
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.
Drug: CRH
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No history of gastrointestinal symptoms or complaints.

Exclusion Criteria:

  • History of allergic reaction to CRH, atopy (eczema, asthma, food allergies, allergic rhinoconjunctivitis) or multiple allergies to several drugs
  • Pregnancy or lactation
  • Concomitant administration of monoamine oxidase inhibitors (MAOI), verapamil or diltiazem or medication affecting esophageal motility
  • Significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic)
  • Prior history of esophageal, Ear Nose and Throat, or gastric surgery or endoscopic anti-reflux procedure
  • History of gastrointestinal disease and first degree relatives with Crohn's disease or celiac disease.
  • During the last two weeks before the study the volunteers should be free from medication, except for oral contraceptives

Information from the National Library of Medicine

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


Locations
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Belgium
Targid, KU Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Prof Dr Jan Tack
Investigators
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Principal Investigator: Jan F Tack, MD, PhD KU Leuven

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Responsible Party: Prof Dr Jan Tack, Prof. Dr., MD, PhD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02736734     History of Changes
Other Study ID Numbers: S57111
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Esophageal Motility Disorders
Esophageal Spasm, Diffuse
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hormones
Adrenocorticotropic Hormone
Corticotropin-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs