Preventing Gastric Glitch With Prucalopride and Buspirone: N-of-1 Clinical Trial

Gastric Glitch: a New Functional Disease Treated With Prucalopride and Buspirone in a N-of-1 Double-blind Clinical Trial

Background: Gastric glitch is a new functional disease characterized by severe and transient epigastric pain occurring after challenges such as drinking alcohol and eating specific foods. Aims: In this N-of-1 trial, we first characterized the clinical and gastric tomographic images of a patient with gastric glitch highly reproducible after alcohol challenging, and then tested the effect of prucalopride and buspirone on the prevention of gastric glitch crises.

Study Overview

• Status: Completed
• Conditions: Dyspepsia
• Intervention / Treatment: Drug: Prucalopride; Drug: Buspirone; Drug: Placebo

Detailed Description

Objective: To evaluate the effect of prucalopride and buspirone, compared to placebo, in the prevention of gastric pain crises, in a double-blind clinical trial of a single patient. Methods: Female, 35 years old, with signed consent to participate in the study, received 15 capsules to take 1 capsule 60 minutes before ingesting 200 ml of red wine at home (≈20 grams of alcohol), twice a week, according to her routine food, totaling 15 meals. Thus, the experimental phase lasted about eight weeks. The 15 capsules contain placebo (5 capsules), prucalopride 2 mg (5 capsules) or buspirone 10 mg (5 capsules), prepared by a specialized pharmacy in such a way that their physical characteristics do not allow the identification of which agent is being administered, neither by the patient nor the investigator controlling the trial (double-blind). The aforementioned pharmacy generated a code for each pill, randomly, and provided a sealed list with the 15 codes and their respective drugs, for disclosure after the end of the study. The patient was instructed to record in a standardized diary the occurrence of pain crises after the wine challenge, as well as their duration and intensity (Likert 0 to 10: maximum pain), and accompanying symptoms. The patient was asked to contact the researchers directly (WhatsApp) throughout the trial, to clarify any doubts or need for some assistance due to the occurrence of symptoms related to the study. The study statistics will be descriptive in terms of pain events, and the effect of the drugs will be evaluated in a statistical model suitable for the N-of-1 trial. Prucalopride is a 5-HT4 receptor agonist that accelerates gastric emptying, while buspirone is a 5-HT1A receptor agonist that enhances gastric accommodation function. The presumed pathophysiology underlying the patient's pain is retention of wine in the gastric lumen, causing pain. Stimulating gastric emptying with prucalopride or increasing the accommodation of the gastric fundus with buspirone could prevent or alleviate the pain crisis.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Passo Fundo, RS, Brazil, 99010-080
      • University of Passo Fundo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• adult patient suffering from severe gastric pain after ingestion of a small amount of wine

Exclusion Criteria:

• N/A (N-of-1 trial)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: prucalopride; prucalopride 2 mg 1 capsule orally 1 hour before the wine challenging (during a dinner), in five dinners (2 dinners per week)	Drug: Prucalopride; prucalopride 2 mg 1 hour before the challenge with intake of wine (200 ml) and a dinner; Other Names: Resolor
Experimental: buspirone; buspirone 10 mg 1 capsule orally 1 hour before the wine challenging (during a dinner), in five dinners (2 dinners per week)	Drug: Buspirone; buspirone 10 mg 1 hour before the challenge with intake of wine (200 ml) and a dinner; Other Names: Ansitec
Placebo Comparator: placebo; placebo 1 capsule orally 1 hour before the wine challenging (during a dinner), in five dinners (2 dinners per week)	Drug: Placebo; placebo 1 hour before the challenge with intake of wine (200 ml) and a dinner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain severity during gastric glitch crises	Pain severity scored by the patient using a Likert scale (1 = minimal / 10 = maximal pain) following wine intake (200 ml)	2 hours after challenging with wine intake

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of side effects secondary to tested drugs	Registration by the patient (symptom diary) concerning the occurrence (yes/not) of side effects potentially related with prucalopride (abdominal cramps, nausea, diarrhea, and headache) and buspirone (drowsiness and dizziness) after each ethylic challange	12 hours after drugs intake

Collaborators and Investigators

• Sponsor: Universidade de Passo Fundo
• Investigators: Principal Investigator: Fernando Fornari, University of Passo Fundo

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2022
• Primary Completion (Actual): March 6, 2022
• Study Completion (Actual): March 6, 2022

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: May 15, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 15, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Receptor Agonists; Anti-Anxiety Agents; Laxatives; Serotonin 5-HT4 Receptor Agonists; Buspirone; Prucalopride
• Other Study ID Numbers: 5.151.164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No