Oesophageal disorder Trials in Disease

Study on Botulinum Toxin Type A Injection for Patients with Inability to Belch Due to Retrograde Cricopharyngeus Dysfunction

This clinical trial is investigating a treatment for people who cannot belch properly due to a problem with a muscle at the top of the oesophagus called the cricopharyngeus muscle. When this muscle doesn't work correctly, air gets trapped in the digestive system, causing uncomfortable symptoms like bloating, stomach discomfort, nausea, and gurgling noises in the chest or neck area.

Main inclusion criteria: To participate in this study, you must be between 18 and 65 years old and have been experiencing difficulty belching for at least 6 months. Your symptoms must be bothersome enough that you're considering treatment. You'll need to have specific test results on a procedure called high resolution impedance manometry that show the muscle isn't relaxing properly when gas tries to move back up from the stomach. Women of childbearing age must use highly effective birth control methods. You'll also need to provide written informed consent before any screening procedures begin.

Main exclusion criteria: You cannot participate if you're able to belch normally, are under 18 years old, are pregnant or breastfeeding, or have received botulinum toxin treatment in the past for any reason. People with other medical conditions that could interfere with the study results or those who cannot provide informed consent are also not eligible. Additionally, you cannot join if you're already participating in another clinical trial.

Focus and goal: The trial aims to evaluate whether an injection of Botulinum toxin type A (commonly known as Botox) into the upper oesophageal sphincter can reduce symptoms of difficulty belching. Participants will receive either the Botox injection or a placebo (an inactive saline solution) and will be followed for 48 weeks. The main evaluation occurs at 12 weeks after treatment, where researchers will measure whether there's at least a 50% improvement in symptoms. Additional assessments take place at 1, 4, 20, and 48 weeks to monitor symptom changes, safety, and patient satisfaction throughout the study period.

Investigational drug: The study uses Botulinum Toxin Type A, which is injected directly into the muscle at the top of the oesophagus. This medication works by blocking the release of a chemical messenger called acetylcholine, which reduces muscle contractions and may help the muscle relax properly to allow air to escape when belching.