drugset / Trial / NCT02664051
Mast Cells in Acid-induced Intestinal Permeability
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | disodium cromoglycate | Unknown | 100 mg | — |