Mechanistic investigation of the link between psychological stress and increased leakiness of the small intestine in healthy volunteers.

Phase 1

• Conditions: Stress-induced intestinal hyperpermeability; MedDRA version: 14.1Level: LLTClassification code 10001039Term: Acute reaction to stressSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2012-001263-73-BE
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-23
• Study Completion: 2013-06-05
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Healthy volunteers between 18 and 25 years old that are subjected to a stressful public speech event.
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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1/chronic gastrointestinal diseases
2/psychiatric disease
3/ diabetes mellitus type1 or 2
4/ celiac disease
5/ atopy (eczema, asthma, food allergies, allergic rhinoconjunctivitis)
6/ first degree relatives with Crohn’s disease, celiac disease or type 1 diabetes mellitus
7/ active smoking
8/ pregnancy
9/ any daily medication besides oral contraceptives

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine whether blockage of mast-cells by cromoglicic acid can prevent stress-induced permeability changes in the small intestine.;Secondary Objective: 1/ Determine whether CRH can mimick stress-induced permeability changes.<br>2/ Determine whether blockage of mast-cells by cromoglicic acid can prevent CRH-induced permeability changes in the small intestine.;Primary end point(s): Prevention of stress-induced intestinal permeability changes by cromoglicic acid assessed by the in vivo lactulose/mannitol sugar urinary excretion test.;Timepoint(s) of evaluation of this end point: After treatment with cromoglicic acid for 2 weeks (urine collection for 4 hours after ingestion of 5g lactulose and 2g mannitol).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1/ Determine whether CRH administration can mimick stress-induced permeability changes in the intestine, determined by the in vivo lactulose/mannitol sugar excretion test<br><br>2/ Determine whether cromoglicic acid treatment for 2 weeks is able to prevent secondary end point (1).;Timepoint(s) of evaluation of this end point: Immediately after administration of CRH intravenously (urine collection for 4 hours after ingestion of 5g lactulose and 2g mannitol).