A Phase 4 interventional study of Nalcrom and placebo in Dyspepsia, sponsored by Universitaire Ziekenhuizen KU Leuven. Terminated at 1 site in Belgium. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-10.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 4, Interventional, and Other
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.
Despite intensive research, the pathophysiology of functional dyspepsia remains unknown. The investigators recently demonstrated that functional dyspepsia patients display impaired duodenal mucosal integrity and low-grade mucosal inflammation. As studies have also shown that functional dyspepsia patients present with an increased spontaneous duodenal acid exposure, the hypothesis of this study is that increased duodenal acid exposure results in increased duodenal permeability via mast cell activation. This will also induce activation of the duodenogastric reflex, resulting in gastric relaxation, eventually leading to the generation of dyspeptic symptoms. The general aim of this project is to assess the effect of mast cell inhibition on duodenal mucosal integrity and intragastric pressure of healthy volunteers after acid infusion in the duodenum.
The study will be a randomized, double-blind, cross-over study in 20 healthy volunteers and consists of 2 parts. (1) In the first part, 10 healthy volunteers will be perfused with acid (0.1N HCl) or 0.9% saline during 30 minutes at a rate of 5 mL/min with an interval of at least one month. During acid/saline perfusion, intragastric pressure will be measured with a high resolution manometry system to evaluate activation of the duodenogastric reflex. Dyspeptic symptoms will be scored 1 minute before and every 5 minutes during the infusion. After perfusion, endoscopy will be performed and duodenal biopsies will be obtained to evaluate mucosal integrity using Ussing chambers and by assessing the expression of cell-to-cell adhesion proteins (real-time PCR, immunofluorescence and western blot). (2) In the second part, 10 healthy volunteers will be perfused with acid after a placebo treatment and after treatment with the mast cell stabilizer disodium cromoglycate 100mg 4x2/day (with an interval of at least one month). The rest of the study continues as described in part 1.
370 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's enrollment of 20 is below the median of 87 across 303 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 958 studies on the registry; 263 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
mannitol
Drug: placebo
disodium cromoglycate
Drug: Nalcrom
Drug: disodium cromoglycate 100mg 4x2 daily Other Names: • Nalcrom
100mg 4x2 daily mannitol
evaluation of transepithelial resistance (mucosal integrity) of duodenal biopsies after duodenal saline or acid perfusion, after treatment with placebo or a mast cell stabilizer
Time frame: 2 weeks
evaluation of intragastric pressure during duodenal saline or acid perfusion, after treatment with placebo or a mast cell stabilizer
Time frame: 2 weeks
The record gives a start of Aug 2013, a primary completion of Dec 2016 and a completion of Jun 2021. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cromolyn
Universitaire Ziekenhuizen KU Leuven →