The effect of stress on esophageal sensitivity

• Conditions: Changed esophageal sensitivity induced by CRH; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2014-000602-36-BE
• Lead Sponsor: KUleuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-14
• Last Update Posted: 28 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Healthy volunteers aged between 18-60 years
No history of gastrointestinal symptoms or complaints.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. history of allergic reaction to CRH,
2.atopy (eczema, asthma, food allergies, allergic rhinoconjunctivis) or multiple allergies to several drugs,
3. pregnancy or lactation,
4.concomitant administration of monoamine oxidase inhibitors (MAOI), verapamil or diltiazem or medication affecting esophageal motility,
5. significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic),
6. prior history of esophageal, ENT or gastric surgery or endoscopic anti-reflux procedure, history of gastrointestinal disease and first degree relatives with Crohn’s disease or celiac disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified