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Completed

NCT Number: NCT05377619

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

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Key information

Conditions

Dyspepsia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Passo Fundo

Passo Fundo, Rio Grande do Sul, 99010-080, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

prucalopride

Drug

prucalopride 2 mg 1 hour before the challenge with intake of wine (200 ml) and a dinner

Other names: Resolor

Buspirone

Drug

buspirone 10 mg 1 hour before the challenge with intake of wine (200 ml) and a dinner

Other names: Ansitec

Placebo

Drug

placebo 1 hour before the challenge with intake of wine (200 ml) and a dinner

Primary outcomes

  1. Pain severity during gastric glitch crises

    Time frame: 2 hours after challenging with wine intake

    Pain severity scored by the patient using a Likert scale (1 = minimal / 10 = maximal pain) following wine intake (200 ml)

Other outcomes

  1. Occurrence of side effects secondary to tested drugs

    Time frame: 12 hours after drugs intake

    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

Sponsors and collaborators

Lead sponsor

Universidade de Passo Fundo

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 17, 2022
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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