# A multicenter, double-blind, randomized, placebo- controlled, parallel study to assess the efficacy of 5- HT4 agonist prucalopride for the treatment of diabetic and idiopathic gastroparesis

> **NIH NIH U01** · TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO · 2024 · $61,800

## Abstract

Abstract
In the clinical world of diagnosis and treatment options for the spectrum of gastroparesis (GP) symptoms, there
are still numerous and challenging needs to understand, while at the same time further investigating the
pathophysiology of this entity, which affects > 10 million of patients in the US. GP patients exhibit a range of
symptoms which do not always correlate with the objective tests we rely on for diagnosis, as well as for assessing
their clinical reactions to pharmacological agents.
Our response to the NIDDK Gastroparesis Consortium (U01) under RFA-DK-20-504 has the following aims:
1) A) Continue and complete already approved studies initiated by the GpCRC, which specifically entails
 enrolling qualified patients to Gastroparesis Registry 3, with all relevant clinical and bio-samples, including
 also PBMC isolation (peripheral blood mononuclear cells), as well as completing the Buspirone (BESST)
 clinical trial; B) Continue obtaining gastric antral and pyloric smooth muscle tissue samples at the time of
 surgeries to further advance our knowledge of pathological basis of gastroparesis (PBG) protocol. C)
 Investigate Pyloric Sphincter Abnormalities in Patients with Gastroparesis Symptoms (PSAGS) per the
 EndoFlip assessment protocol.
 B) Our additional proposals for the GP Registry 4 (GpR4) are: 1) During the routine EGD for GpR4 and
 possible PSAGS studies, we would like to collect samples of duodenal and gastric microbiota by obtaining
 brushings of gastric and duodenal mucosa; 2) biopsy antral muscularis propria tissue using Endoscopic
 Submucosal Dissection (ESD) methodology during upper GI endoscopy .
2) As a new research strategy, we propose to investigate whether microbiota obtained at the time of endoscopy
 by brushing the mucosa of the stomach and duodenum, will differ in their composition in idiopathic and
 diabetic GP and control patients. We hypothesize that dysbiosis of the upper GI microbiota may contribute
 to the delayed gastric emptying and symptoms in GP patients, particularly in the idiopathic subgroup of our
cohort.
3) Our clinical trial proposal is to investigate the therapeutic efficacy of a new selective 5-HT4 receptor agonist,
 Pruclalopride, to improve the symptoms and gastric emptying in idiopathic and diabetic GP patients while at
 the same time having an excellent safety profile. A multicenter, double blind, randomized, placebo-
 controlled, parallel study, will be conducted were all GpR4 patients from all centers will be invited to be
 enroll into 2 parallel 4-week treatment periods with placebo or pruclalopride 2mg QD trial.

## Key facts

- **NIH application ID:** 11127230
- **Project number:** 3U01DK074035-15S1
- **Recipient organization:** TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO
- **Principal Investigator:** Richard Warwick McCallum
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $61,800
- **Award type:** 3
- **Project period:** 2008-09-30 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11127230

## Citation

> US National Institutes of Health, RePORTER application 11127230, A multicenter, double-blind, randomized, placebo- controlled, parallel study to assess the efficacy of 5- HT4 agonist prucalopride for the treatment of diabetic and idiopathic gastroparesis (3U01DK074035-15S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11127230. Licensed CC0.

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