IVIG for Gastroparesis
(GAIN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a treatment called IVIG for individuals whose gastrointestinal (GI) issues, such as severe difficulty digesting food, do not improve with standard treatments. The focus is on those who may have autoimmune problems affecting their GI tract, where the body's defense system mistakenly attacks its own nerves, causing digestion problems. The goal is to assess patient responses to IVIG, a therapy made from antibodies. Individuals with persistent GI issues that have not improved with other treatments might be suitable candidates for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Will I have to stop taking my current medications?
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.
What prior data suggests that IVIG is safe for treating autoimmune gastrointestinal neuropathies?
Research has shown that intravenous immunoglobulin (IVIG) is generally safe for people and is unlikely to cause harm in most cases. However, like any treatment, it can have side effects. Rare side effects include kidney problems, blood clots, irregular heartbeats, and lung issues.
Despite these rare side effects, most patients tolerate IVIG well. Healthcare providers typically monitor vital signs such as blood pressure and heart rate during treatment to ensure safety. Overall, many experts consider IVIG a relatively safe option for treating certain conditions.12345Why are researchers excited about this trial?
Researchers are excited about using intravenous immunoglobulin (IVIG) for gastrointestinal auto-immune neuropathy because it offers a fresh approach to treating a condition that doesn’t respond well to standard therapies. Unlike traditional treatments, which often include immunosuppressive drugs or dietary modifications, IVIG works by delivering a concentrated dose of antibodies directly into the bloodstream. This method may help modulate the immune system more effectively, potentially reducing inflammation and nerve damage. The promise of IVIG lies in its ability to target the underlying immune dysfunction, offering hope for patients who haven't found relief with existing options.
What is the effectiveness track record for IVIG in treating autoimmune gastrointestinal neuropathies?
Research has shown that intravenous immunoglobulin (IVIG) can treat conditions where the immune system mistakenly attacks the body's nerves, such as autoimmune gastrointestinal neuropathy. Studies have found that IVIG reduces disease activity and decreases the need for other strong medications, like corticosteroids. In one study, patients who received IVIG improved faster than those who received a placebo. Many individuals experienced noticeable benefits in managing their symptoms with IVIG treatment. Overall, IVIG offers promise for those whose other treatments haven’t worked.678910
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 receive intravenous immunoglobulin (IVIG) therapy in 12-week courses
Follow-up
Participants are monitored for safety and effectiveness after treatment using standardized patient reported outcome (PRO) surveys
What Are the Treatments Tested in This Trial?
Interventions
- IVIG
IVIG is already approved in United States, European Union, Canada for the following indications:
- Primary immunodeficiency diseases
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
- Multifocal motor neuropathy
- Kawasaki disease
- Immune thrombocytopenic purpura (ITP)
- Primary immunodeficiency syndromes
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
- Multifocal motor neuropathy
- Kawasaki disease
- Immune thrombocytopenic purpura (ITP)
- Primary immunodeficiency diseases
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
- Multifocal motor neuropathy
- Kawasaki disease
- Immune thrombocytopenic purpura (ITP)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Louisville
Lead Sponsor
Citations
Outcomes of intravenous immunoglobulin treatment ...
Secondary clinical outcomes included hospital readmission within 30 days of discharge, death during hospitalization, and serious adverse effects ...
Intravenous immunoglobulin as a therapy for autoimmune ...
The results demonstrated a notable efficacy of immunoglobulin in reducing disease activity and in tapering the dose of systemic corticosteroids ...
Comparative effectiveness of two intravenous ...
Outcomes are summarized in Table 3. Privigen demonstrated a lower IVIG resistance rate at 9.4% in comparison to TBSF, which exhibited a rate of ...
Trial of Intravenous Immune Globulin in Dermatomyositis
The median time to at least minimal improvement was 35 days with IVIG and 115 days with placebo. The results of the other secondary end-point ...
Intravenous Immunoglobulin Treatment Patterns and ...
On average, patients received IVIG every 21 days for 129 days. By 2 years, 55% of patients had stopped receiving IVIG; most of those patients ...
6.
labeling.cslbehring.com
labeling.cslbehring.com/SDS/AU/Normal-Immunoglobulin-VF/EN/Normal-Immunoglobulin-VF-Safety-Data-Sheet.pdfSafety Data Sheet Normal Immunoglobulin-VF 1. Identification
Normal Immunoglobulin-VF treats low antibody levels and prevents infections. It is not classified as hazardous, but all blood products should ...
7.
sigmaaldrich.com
sigmaaldrich.com/sds/sigma/56834?srsltid=AfmBOoqJ7Z1FUQ_sGLYU9DdAkqSAmxYaUY5Farzxi8qE_HscqCt9BsIwSAFETY DATA SHEET
OSHA: No component of this product present at levels greater than or equal to 0.1% is on OSHA's list of regulated carcinogens. Reproductive ...
Adverse Effects of Immunoglobulin Therapy - PMC
Some rare side effects, including renal impairment, thrombosis, arrhythmia, aseptic meningitis, hemolytic anemia, and transfusion-related acute lung injury ( ...
9.
primaryimmune.org
primaryimmune.org/resources/news-articles/safety-important-successful-immunoglobulin-replacement-therapySafety important for successful immunoglobulin ...
Another important safety step with IVIG is to make sure the nurse monitors blood pressure, heart rate, temperature, and respiration rate. A full ...
Safety of Intravenous Immunoglobulin | JAMA Neurology
A major factor fueling the current interest in IVIG is its relative safety. It is regarded by some as virtually riskless.
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