Latiglutenase for Celiac Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called latiglutenase in individuals with both Type 1 diabetes and celiac disease. The researchers aim to determine if latiglutenase can help manage symptoms in those who have followed a gluten-free diet for at least a year but still experience issues. Participants will receive either the active treatment or a placebo (a pill with no active medicine). Suitable candidates for this trial have both conditions, follow a gluten-free diet, and continue to experience symptoms like stomach pain or discomfort. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators.
Is there any evidence suggesting that Latiglutenase is likely to be safe for humans?
Research shows that latiglutenase is generally safe for use. Earlier studies found that this pill protects the small intestine and lessens gluten-related symptoms without causing major side effects. However, it did not improve tissue health for all individuals with celiac disease. While some studies suggest the need for further research, current evidence indicates that latiglutenase is safe for most people when used as directed.12345
Why do researchers think this study treatment might be promising for diabetes and celiac disease?
Latiglutenase is unique because it targets the breakdown of gluten, which can be a significant issue for people with both type 1 diabetes (T1D) and celiac disease (CD). Unlike traditional treatments that primarily focus on managing blood sugar or avoiding gluten entirely, latiglutenase offers a potential way to help digest gluten more effectively. This mechanism could reduce the immune response triggered by gluten in people with CD, potentially improving quality of life by allowing for more dietary flexibility. Researchers are excited about latiglutenase because it addresses a specific unmet need for those managing both conditions simultaneously.
What evidence suggests that Latiglutenase might be an effective treatment for Type 1 diabetes and celiac disease?
Research has shown that latiglutenase, which participants in this trial may receive, can protect the small intestine and reduce symptoms for people with celiac disease, especially after accidental gluten ingestion. Studies have found that taking this treatment as a pill with meals helps break down gluten in the stomach, reducing the severity of symptoms when gluten is consumed by mistake. Previous users have experienced fewer symptoms without major side effects. Although primarily studied for celiac disease, research suggests latiglutenase might also benefit those with both celiac disease and Type 1 diabetes who are adhering to a gluten-free diet.13567
Who Is on the Research Team?
David Maahs, MD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Latiglutenase or placebo in a double-blind, crossover design
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Latiglutenase
Find a Clinic Near You
Who Is Running the Clinical Trial?
Entero Therapeutics
Lead Sponsor
Immunogenics, LLC
Industry Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator