Neuromodulation, Pyloric Therapies, and Immunotherapy for Gastroparesis
(GOLDEN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how different treatments affect people with gastroparesis, a condition where the stomach doesn’t empty food properly. Researchers are examining three main treatments: GI neuromodulation (stimulating nerves in the digestive system), immunotherapy (boosting the immune system), and pyloric therapies (targeting the stomach valve). The trial will track symptoms, quality of life, and other factors over time, regardless of whether participants receive a treatment. Individuals struggling with gastroparesis symptoms that don’t improve with drugs and have nutritional issues might be a good fit for this study.
As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group of people, offering a chance to contribute to potentially groundbreaking findings.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found that a noninvasive treatment called GI neuromodulation effectively and safely improved gut symptoms and movement issues. This treatment uses electrical signals to enhance the function of digestive system muscles. Another study found that a new type of neuromodulation showed promise and was well-tolerated, but further research is needed to confirm these findings.
For immunotherapy, research has shown that while there are benefits, some patients experience side effects. About 60% of patients had immune-related issues, such as new symptoms or flare-ups of existing ones. This indicates a risk of side effects, which can vary from person to person.
Regarding treatments for the stomach's pyloric valve, one study demonstrated that a combination treatment significantly improved gastric emptying and eased symptoms. However, more than two-thirds of patients in another study did not experience major symptom relief over a year. Despite this, some newer, less invasive methods have proven to be safe and effective.
Overall, these treatments vary in safety and effectiveness. Patients may have different experiences, so discussing these options with a healthcare provider is important.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for gastroparesis because they offer innovative approaches that differ from typical care options like dietary modifications, medications to stimulate stomach muscles, and surgical interventions. GI neuromodulation is unique as it involves stimulating the nerves that control stomach muscles, potentially improving gastric emptying and reducing symptoms. Immunotherapy targets the immune response, aiming to address any underlying inflammation contributing to gastroparesis, which is not a focus of current treatments. Pyloric therapies, such as pyloric botulinum toxin injections, offer a more direct approach by relaxing the pyloric valve to improve gastric emptying, providing a targeted alternative to more generalized methods.
What evidence suggests that this trial's treatments could be effective for gastroparesis?
This trial will evaluate three main interventions for individuals with gastroparesis symptoms: GI neuromodulation, immunotherapy, and pyloric therapies. Studies have shown that GI neuromodulation, specifically gastric electrical stimulation (GES), can improve symptoms in gastroparesis patients. In one study, 78% of patients who received GES reported overall improvement, compared to 58% of those who did not receive the treatment. While direct evidence for immunotherapy's effectiveness in gastroparesis is limited, it has shown promise in alleviating symptoms in other digestive conditions. Pyloric treatments, such as pyloric drainage and gastric peroral endoscopic myotomy (G-POEM), have effectively improved symptoms and accelerated stomach emptying in over 75% of patients. G-POEM, in particular, has demonstrated long-term success rates of about 98.6%.36789
Who Is on the Research Team?
Thomas Abell, MD
Principal Investigator
University of Louisville
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants may receive interventions such as GI neuromodulation, immunotherapy, or pyloric therapies
Follow-up
Participants are monitored for changes in symptoms, quality of life, and other health measures
What Are the Treatments Tested in This Trial?
Interventions
- GI Neuromodulation
- Immunotherapy
- Pyloric Therapies
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
People presenting with the symptoms of gastroparesis. The three main interventions are GI neuromodulation, immunotherapy, and pyloric therapies.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Louisville
Lead Sponsor
Citations
Effectiveness of Gastric Electrical Stimulation in Gastroparesis
In the unadjusted analysis, 78% of GES therapy patients improved in the GCSI total score, whereas 58% improved among non-GES patients (relative risk (RR) = 1.33 ...
Gastric Electrical Stimulation for the Treatment of ...
Conclusion. GES appears beneficial, with significant improvement in GI TSS, weekly vomiting frequency, gastric emptying study, and quality of life.
Gastrointestinal neuroprosthesis for motility and metabolic ...
These results suggest that the neuroprosthesis can be used to artificially generate peristalsis and increase gastric motility. Metabolic ...
Effectiveness of Gastric Neurostimulation in Patients With ...
In 2008 Velanovich showed that roughly three-quarters of gastroparesis patients treated with GES showed improvement in their gastrointestinal symptoms, although ...
Efficacy of Gastric Electrical Stimulation for Gastroparesis
Vomiting was decreased by 62% after GES implant in the European centers and by 45% in the US centers. In the European centers, the patients' TSS was decreased ...
H990014 - Enterra® Therapy System
This document summarizes the safety data FDA reviewed in the year following our 2023 report to the PAC. It includes data from the ...
Noninvasive Electrical Neuromodulation for Gastrointestinal ...
Noninvasive neuromodulation is effective and safe in improving both gastrointestinal symptoms and dysmotility, it can be used when pharmacotherapy is ...
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journals.lww.com
journals.lww.com/ajg/fulltext/2021/10001/s1440_novel_neuromodulation_treatment_using.1444.aspxS1440 Novel Neuromodulation Treatment Using Repetitive...
ThorS-MagNT appears to be feasible, safe and a promising novel treatment for refractory DGp. Further studies are needed in larger samples to assess its effects ...
Noninvasive electrical neuromodulation for gastrointestinal ...
Noninvasive neuromodulation is effective and safe in improving both gastrointestinal symptoms and dysmotility; it can be used when pharmacotherapy is ...
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