Prospective, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Type 1 Diabetes Patients With Celiac Disease While Undergoing Periodic Gluten Exposure
ClinicalTrials.gov processed this data on August 1, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
TERMINATED (See Contacts and Locations)Verified July 2023 by Entero Therapeutics, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Immunogenics, LLC
Sponsor
Entero TherapeuticsInformation Provided by (Responsible Party)
Entero TherapeuticsClinicaltrials.gov Identifier
NCT04839575Other Study ID Numbers: IMGX003-NIDDK-1921
First Submitted: April 7, 2021
First Posted: April 9, 2021
Last Update Posted: August 5, 2024
Last Verified: July 2023
History of Changes
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Study Description
This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening. Seropositive subjects (blood test confirmed at Visit 0) will be scheduled for a Screening Visit (Visit 1) whereas seronegative subjects will be discontinued from study participation (screen failures). Subjects who meet Visit 1 protocol enrollment criteria will be enrolled.Condition or Disease | Intervention/Treatment |
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Study Design
Study Type | Interventional |
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Actual Enrollment | 13 participants |
Design Allocation | Non-Randomized |
Interventional Model | Crossover Assignment |
Masking | Double |
Primary Purpose | Treatment |
Official Title | Prospective, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Type 1 Diabetes Patients With Celiac Disease While Undergoing Periodic Gluten Exposure |
Study Start Date | April 6, 2021 |
Actual Primary Completion Date | December 19, 2022 |
Actual Study Completion Date | December 19, 2022 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- Symptom Severity Reduction [6 months] The primary efficacy endpoint of this study is absolute mean reduction in symptom severity relative to placebo.
Eligibility Criteria
Ages Eligible for Study | 18 Years to 80 Years (Adult, Older Adult) |
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Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
Inclusion Criteria |
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Exclusion Criteria |
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Contacts and Locations
Sponsors and Collaborators | Entero Therapeutics, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Immunogenics, LLC |
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Immunogenics, LLC | |
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Investigators |
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More Information
Additional Relevant MeSH Terms
- Celiac Disease
- Malabsorption Syndromes
- Intestinal Diseases
- Gastrointestinal Diseases
- Digestive System Diseases
- Metabolic Diseases