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

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05377619
• Other study ID #: 5.151.164
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 6, 2022
• Est. completion date: March 6, 2022

Study information

• Verified date: May 2022
• Source: Universidade de Passo Fundo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: March 6, 2022
• Est. primary completion date: March 6, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Drug:
• Prucalopride
prucalopride 2 mg 1 hour before the challenge with intake of wine (200 ml) and a dinner
• Buspirone
buspirone 10 mg 1 hour before the challenge with intake of wine (200 ml) and a dinner
• Placebo
placebo 1 hour before the challenge with intake of wine (200 ml) and a dinner

Locations

Country	Name	City	State
Brazil	University of Passo Fundo	Passo Fundo	RS

Sponsors (1)

Lead Sponsor	Collaborator
Universidade de Passo Fundo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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