Mast Cells in Acid-induced Intestinal Permeability

• Status: Unknown status
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Treatments: Cromolyn Sodium

Criteria

Inclusion Criteria:

• healthy

Exclusion Criteria:

• - 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