Mechanistic investigation of the link between duodenal acid and increased leakiness of the small intestine in healthy volunteers

The role of mast cells on duodenal permeability after duodenal acid perfusion in healthy volunteers - Mast cells in acid-induced intestinal permeability

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000244-42-BE

Enrollment

Registered

2015-03-17

Start date

2015-04-21

Completion date

Unknown

Last updated

2025-04-14

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

Conditions

To investigate the role of mast cells on duodenal permeability after duodenal acid perfusion. The study will be done in healthy volunteers and the results will give an indication about the role of acid in functional dyspepsia MedDRA version: 17.1 Level: LLT Classification code 10064536 Term: Functional dyspepsia System Organ Class: 100000004856

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 60 years old with no history of gastrointestinal symptoms 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: - refused informed consent - pregnant women or women who are breastfeeding - diabetes - coagulation disorders - first degree relatives with celiac disease, Crohn's disease or type I diabetes - intake of medication

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effect of mast cell inhibition on duodenal mucosal integrity of healthy volunteers after acid infusion in the duodenum;Secondary Objective: Not applicable;Primary end point(s): Prevention of alterations on duodenal mucosal permeability after acid infusion on the duodenum, by cromoglicic acid administration in healthy volunteers;Timepoint(s) of evaluation of this end point: after treatment with cromoglicic acid for 2 weeks (duodenal biopsy collection)	—

Measure

Time frame

Main Objective: To assess the effect of mast cell inhibition on duodenal mucosal integrity of healthy volunteers after acid infusion in the duodenum;Secondary Objective: Not applicable;Primary end point(s): Prevention of alterations on duodenal mucosal permeability after acid infusion on the duodenum, by cromoglicic acid administration in healthy volunteers;Timepoint(s) of evaluation of this end point: after treatment with cromoglicic acid for 2 weeks (duodenal biopsy collection)

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactHanne Vanheel

KU Leuven

hanne.vanheel@med.kuleuven.be

Outcome results

None listed

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