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Enzyme
Latiglutenase for Celiac Disease
Phase 2
Waitlist Available
Led By Joseph Murray, MD
Research Sponsored by Entero Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Summary
This trial is testing a new treatment for people with celiac disease who still have symptoms despite following a gluten-free diet. The goal is to see if this new treatment can help reduce their symptoms.
Eligible Conditions
- Celiac Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Symptom Severity Reduction
Secondary study objectives
Health Related Quality of Life
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: LatiglutenaseActive Control1 Intervention
IMGX003
Group II: PlaceboPlacebo Group1 Intervention
Placebo
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Who is running the clinical trial?
Entero TherapeuticsLead Sponsor
9 Previous Clinical Trials
327 Total Patients Enrolled
2 Trials studying Celiac Disease
53 Patients Enrolled for Celiac Disease
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,316 Previous Clinical Trials
5,547,665 Total Patients Enrolled
Immunogenics, LLCLead Sponsor
3 Previous Clinical Trials
132 Total Patients Enrolled
3 Trials studying Celiac Disease
132 Patients Enrolled for Celiac Disease
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been told by a doctor that you have Type 1 Diabetes.You are allergic to wheat.You have a history of stomach ulcers, esophagus inflammation, irritable bowel syndrome, or inflammatory bowel disease.You have had certain types of stomach surgery that make food move through your stomach too quickly.You have had a long-lasting or recent infection in your stomach or intestines.You have had at least one symptom that you would describe as moderate or worse in the past 28 days.You have active colitis or dermatitis herpetiformis.You have a type of celiac disease that hasn't responded to treatment.You have been diagnosed with Crohn's disease through a biopsy.You have tested positive for a particular virus or infection.You have been on a gluten-free diet for at least 12 months.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Latiglutenase
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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