Antineuronal Antibodies for Autoimmune Gastrointestinal Dysmotility
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how certain antibodies, proteins made by the immune system, might affect people with unexplained stomach movement problems. These issues, known as gastrointestinal motility disorders, hinder the normal movement of food through the stomach and intestines. Researchers aim to determine if these antibodies, specifically novel antineuronal antibodies, cause the problems by testing the blood of affected individuals. People with ongoing, unexplained digestive issues who have been referred to a specialist might be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Do I have to stop taking my current medications for 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 study team to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that about 10% of people with unexplained gut movement problems have special proteins called antibodies that can mistakenly attack the body’s nervous system. These antibodies are linked to autoimmune disorders, where the body attacks itself by mistake.
Although these antibodies are often found in people with gut movement issues, little information exists on the safety of treatments using these antibodies. This study is in an early phase, just beginning to test the treatment's safety and effectiveness. The main goal is to observe how the body reacts to the treatment and identify any possible side effects.
Since the treatment is still in early testing, information on its safety remains limited. However, these studies prioritize safety. Researchers will closely monitor participants to ensure any reactions are quickly noticed and managed.12345Why are researchers excited about this trial?
Unlike the standard of care for gastrointestinal motility disorders, which often involves medications that aim to stimulate or regulate muscle contractions in the digestive tract, the novel antineuronal antibodies target the underlying neuronal interactions that control these movements. Most current treatments, like prokinetic agents, focus on symptom relief rather than addressing the root cause. These antibodies are designed to precisely target and neutralize specific proteins involved in neuronal signaling, potentially offering a more effective and direct approach to restoring normal motility. Researchers are excited because this could lead to not only improved symptom management but also a deeper understanding of the condition itself.
What evidence suggests that this trial's treatments could be effective for gastrointestinal motility disorders?
Research has shown that some gut movement problems link to certain proteins called antineuronal antibodies. These proteins can mistakenly attack the body's nerve cells, potentially causing gut issues. Studies have found these antibodies more commonly in people with these gut problems, affecting gut function, such as altering bowel movements. This trial will investigate the role of these antibodies in patients with gastrointestinal dysmotility, suggesting that targeting them might help treat the condition.26789
Who Is on the Research Team?
Ken J Hui, MD
Principal Investigator
Johns Hopkins University
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
Antibody and DNA Isolation
Participants undergo serum screening for antigens and antibodies, and DNA isolation is performed
Follow-up
Participants are monitored for safety, tolerability, and clinical improvement after initial screening
What Are the Treatments Tested in This Trial?
Interventions
- Novel Antineuronal Antibodies
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients with GI dysmotility
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Citations
1.
clinicaltrial.be
clinicaltrial.be/en/details/44373?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&only_active=0&only_eligible=0&only_recruiting=0&per_page=20Novel Antineuronal Antibodies in Gastrointestinal Motilit...
The goal of this study is to determine the prevalence of autoimmune antibodies in patients presenting with unexplained GI dysmotility and ...
Enteric Autoantibodies and Gut Motility Disorders - PMC
There is increasing evidence that a subset of gastrointestinal motility disorders is associated with the presence of circulating antibodies.
High prevalence and functional effects of serum ...
In this study, we examined the frequency and functional effects of antineuronal antibodies in gastrointestinal patients.
Full article: Autoimmune gastrointestinal dysmotility
Antineuronal autoantibodies are often detected in patients with AGID. Autoantibodies play a key role in GI dysmotility; however, whether they cause neuronal ...
5.
researchgate.net
researchgate.net/publication/322580445_High_prevalence_and_functional_effects_of_serum_antineuronal_antibodies_in_patients_with_gastrointestinal_disorders(PDF) High prevalence and functional effects of serum ...
Conclusions & inferences: Antineuronal antibodies were significantly more frequent in GI patients and associated with functional effects on bowel secretion.
Novel Antineuronal Antibodies in Gastrointestinal Motility ...
Approximately 10% of patients with unexplained gastrointestinal dysmotility diseases have positive serum autoantibodies to peripheral nervous system proteins, ...
Recent Advances in the Management of Severe ...
In this article, we review current understanding and the utility of diagnostic modalities and therapeutic approaches, and describe how their limitations may ...
P101 Gastrointestinal dysautonomia after immune ...
GI-dysautonomia is a rare, but serious, complication of ICI therapy that requires a high index of suspicion and early initiation of high-dose immunosuppression.
Enteric neuronal autoantibodies in pseudoobstruction with ...
This novel autoantibody activity suggests that intestinal pseudoobstruction occurring in patients with small-cell carcinoma may have an autoimmune basis. From a ...
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