Ongoing Clinical Trials for Eructation
Currently, there is one ongoing clinical trial investigating treatment options for people who experience difficulty belching. This trial is taking place in Belgium and focuses on using Botulinum Toxin Type A (commonly known as Botox) injections to help people with a condition called retrograde cricopharyngeus dysfunction, which prevents them from being able to burp normally.
Clinical trial locations
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 condition called retrograde cricopharyngeus dysfunction. This condition occurs when a muscle at the top of the esophagus, called the upper esophageal sphincter, does not relax properly to allow trapped air to escape from the stomach. This can cause uncomfortable symptoms such as bloating, nausea, abdominal discomfort, excessive gas passing through the lower digestive tract, and gurgling noises from the chest or lower neck.
Main inclusion criteria:
- Adults between 18 and 65 years old
- Have been experiencing bothersome inability to belch for at least 6 months
- Have associated symptoms such as bloating, nausea, discomfort, or gurgling noises
- Have typical findings on a specialized test called high resolution impedance manometry with belch provocation test, which shows that air gets trapped because the muscle does not relax properly
- Must use highly effective birth control methods if applicable
- Must provide written consent to participate
Main exclusion criteria:
- People who can belch normally without symptoms
- Those with other medical conditions that could interfere with the study
- Pregnant or breastfeeding women
- Anyone who has previously received botulinum toxin treatment for any reason
- Those unable to provide informed consent
- People already participating in another clinical trial
Focus and goal of the trial:
The study aims to evaluate whether injections of Botulinum Toxin Type A (Botox) into the upper esophageal sphincter can effectively reduce symptoms of difficulty belching. Participants will receive either the Botox injection or a placebo (saline solution) and will be monitored over 48 weeks to assess improvement in symptoms and safety.
The trial follows a structured timeline. After initial eligibility assessments, participants receive the injection. They are then evaluated at regular intervals: 1 week, 4 weeks, and 12 weeks after treatment for short-term effects. The primary evaluation occurs at 12 weeks, where researchers will determine if there has been at least a 50% improvement in symptoms. Long-term follow-up continues until 48 weeks, with additional assessments including specialized tests at 20 weeks to objectively measure changes in how the esophageal muscles function.
Throughout the study, participants complete questionnaires about their symptoms, quality of life, and any side effects they experience. The researchers will compare results between those who received Botox and those who received the placebo to determine if this treatment provides meaningful relief for people suffering from this condition.
Investigational drug:
The medication being tested is Botulinum Toxin Type A, commonly known as Botox. It works by blocking the release of a chemical messenger called acetylcholine, which reduces muscle contractions. When injected into the upper esophageal sphincter muscle, it is hoped that this will help the muscle relax properly and allow trapped air to escape, thereby relieving symptoms of being unable to belch.
Summary
Currently, there is only one clinical trial available for people struggling with the inability to belch due to retrograde cricopharyngeus dysfunction. This trial is being conducted in Belgium and represents an important effort to find effective treatment options for a condition that can significantly affect daily comfort and quality of life. The study focuses specifically on using Botulinum Toxin Type A injections, which is a novel approach to treating this particular dysfunction of the upper esophageal sphincter. For individuals experiencing chronic symptoms of trapped gas, bloating, and related discomfort, this trial may offer hope for relief through a relatively simple injection procedure. The 48-week follow-up period will provide valuable information about both the short-term and long-term effectiveness and safety of this treatment approach.