MedTrace Logo

The Effect of Corticotrophin-releasing Hormone (CRH) on Esophageal Sensitivity in Healthy Volunteers

NCT02674256 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-02-04

No results posted yet for this study

Summary

Introduction and aim

Stress is well known to affect visceral sensitivity in Human. The investigators speculate that visceral hypersensitivity plays an important role in symptom perception in gastro-esophageal reflux disease (GERD). The role of acute stress mimicked by corticotrophin releasing hormone (CRH) administration on esophageal sensitivity has not been studied. The investigators hypothesize that stress mediated through CRH-release increases esophageal sensitivity. A first step in the investigation of this hypothesis is to study whether administration of CRH has an influence on esophageal sensitivity in healthy volunteers (HV). Therefore, the aim of this study is to investigate the effect of CRH-administration on esophageal sensitivity in a group of HV.

Methods

The study will be performed in cross-over on 15 HV with no prior history of digestive disease. Esophageal sensitivity will be tested by multimodal stimulation on two sessions (placebo and CRH-administration), with an interval at least of one week. The two sessions will be scheduled by randomization for every subject. After blinded administration of CRH 100µg or placebo IV, esophageal sensitivity will be assessed using a multimodal esophageal stimulation probe which allows thermal, mechanical, electrical and chemical stimulations of the esophagus. Esophageal sensitivity will be assessed using Visual Analogue Scale (VAS), the mood with specific questionnaires (Manikin Self assessment SAM, Profile of Mood Schedule (POMS, State Trait Anxiety Inventory (STAI)) and the cortisol with salivary samples.

Statistical analysis

Esophageal sensitivity for the different stimuli (heat, mechanical, electrical and chemical) will be compared between CRH and placebo conditions. To determine the stress-inducing capability of CRH-administration, the POMS questionnaire, STAI, Manikin self assessment and cortisol levels after the stress-protocol will be compared with the basal measurements.

Perspectives

If CRH-administration increases esophageal sensitivity, a stress model could be applied to investigate the influence of a real life stressor on esophageal sensitivity in healthy subjects. In a third part, a mast-cell stabilizing drug could be tested after administration of a stressor in order to investigate its role on esophageal sensitivity. In the future, this might be proposed to refractory GERD in a controlled randomized trial.

Conditions

  • Sensitivity (Hyper); Gastrointestinal

Interventions

DRUG

CRH

100µg CRH powder for injection (CRH ferring®, Ferring, Aalst, Belgium) and 1 mL of NaCl 0.9% will be put together, then the solution will be injected intravenously over the course of 1 minute

OTHER

Placebo

1 mL of NaCl 0.9% will be injected intravenously over the course of one minute

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Jan F Tack, MD, PhD · KU Leuven

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-05-31
Completion
2014-05-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02674256 on ClinicalTrials.gov