TerminatedPhase 4

Mast Cells in Acid-induced Intestinal Permeability

Stopped: Inactive

Belgium20 participantsStarted 2013-08

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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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

What they're measuring

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

Timeframe: 2 weeks

Trial details

NCT IDNCT02664051

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12

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