13 Participants Needed

Study of Latiglutenase in T1D/CD Patients

AN
JS
Overseen ByJack Syage, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Entero Therapeutics
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies people with both Type 1 diabetes and celiac disease who have been on a gluten-free diet for a significant period. The goal is to see if avoiding gluten helps manage both conditions better. By not eating gluten, these patients can prevent their immune system from damaging their intestines, which might also help control their diabetes.

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.

Who Is on the Research Team?

DM

David Maahs, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

Inclusion Criteria

Confirmed T1D diagnosis
Seropositive
You have had a moderate or severe symptom that you have identified and reported in the last 28 days.
See 4 more

Exclusion Criteria

Known refractory celiac disease (RCD1 or RCD2)
You are allergic to wheat.
Inability to give informed consent
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive either Latiglutenase or placebo in a double-blind, crossover design

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Latiglutenase
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: LatiglutenaseActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Entero Therapeutics

Lead Sponsor

Trials
10
Recruited
410+

Immunogenics, LLC

Industry Sponsor

Trials
4
Recruited
220+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+
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