Mast Cells in Acid-induced Intestinal Permeability

NCT02664051 | Terminated Phase 4

• 2 other identifiers: S568812015-000244-42
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, cross-over study in healthy volunteers. In the first part, the duodenum of the participants will be perfused with acid or saline, during which intragastric pressure will be monitored to assess activation of the duodenogastric reflex. After perfusion, duodenal biopsies will be collected to evaluate mucosal integrity. In the second part, healthy volunteers are treated with the mast cell stabilizer disodium cromoglycate or with a placebo during 14 days. Subsequently, the duodenum will be perfused with acid and intragastric pressure and mucosal integrity will be evaluated.

Conditions

Dyspepsia

Outcome Measures

Primary Outcomes (1)

• evaluation of transepithelial resistance (mucosal integrity) of duodenal biopsies after duodenal saline or acid perfusion, after treatment with placebo or a mast cell stabilizer

  2 weeks

Secondary Outcomes (1)

• evaluation of intragastric pressure during duodenal saline or acid perfusion, after treatment with placebo or a mast cell stabilizer

  2 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

mannitol

Drug: placebo

disodium cromoglycate

ACTIVE COMPARATOR

disodium cromoglycate

Drug: Nalcrom

Interventions

Nalcrom DRUG

Drug: disodium cromoglycate 100mg 4x2 daily Other Names: • Nalcrom

disodium cromoglycate

placebo DRUG

100mg 4x2 daily mannitol

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy

You may not qualify if:

• \- refused informed consent
• pregnant women or women who are breastfeeding
• symptoms or history of gastrointestinal disease
• diabetes mellitus
• coagulation disorders/anticoagulant therapy
• first degree relatives with celiac disease, Crohn's disease or type I diabetes mellitus
• taking antihistamines, ketotifen, cromoglycate, acetylsalicylates, NSAIDs, anticholinergics, theophylline, β2-agonists, codeine or opioid derivatives 2 weeks prior to the study
• taking steroid or immunosuppressive drugs 6 months prior to the study

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven Campus Gasthuisberg O&N1

Leuven, Vlaams Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

Cromolyn Sodium

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: January 26, 2016
• Study Start: August 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: June 29, 2021
• Last Updated: July 10, 2024

Record last verified: 2015-11

Locations

BE (1)