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

Involvement of corticotrophin-releasing hormone (CRH) and mucosal mast cells in stress-induced changes in intestinal permeability in healthy volunteers. - Mast cells in stress-induced intestinal permeability.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001263-73-BE

Enrollment

Registered

2012-04-23

Start date

2012-05-25

Completion date

Unknown

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress-induced intestinal hyperpermeability MedDRA version: 14.1 Level: LLT Classification code 10001039 Term: Acute reaction to stress System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: Nalcrom Product Name: Nalcrom Pharmaceutical Form: Capsule INN or Proposed INN: CROMOGLICIC ACID CAS Number: 16110-51-3 Current Sponsor code: Cromoglicic Acid Other descriptive name: Cromo

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 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).	—

Measure

Time frame

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. 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).

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Secondary

Measure	Time frame
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 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).	—

Measure

Time frame

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 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).

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026