drugset / Trial / NCT02664051

Mast Cells in Acid-induced Intestinal Permeability

NCT02664051

Phase 4 Terminated 20 enrolled Universitaire Ziekenhuizen KU Leuven
RandomizedCrossoverQuadruple-blindOther

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.

Timeline

Start
2013-08
Primary completion
2016-12
Completion
2021-06-29

Drugs

EvaluationDrugModalityDoseRoute
Subject disodium cromoglycate Unknown 100 mg

Indications