PTG-100 for Patients With Celiac Disease

Status Completed

Clinical Trial Summary

The goal of this study is to learn whether or not the drug PTG-100 can reduce or prevent inflammatory injury to the small intestine that occurs when people with celiac disease eat food products containing gluten. This is a clinical research study to determine the safety and efficacy of PTG-100 in preventing gluten-induced inflammatory injury to the small intestine in patients with celiac disease. 30 patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days. They will also receive a gluten challenge twice daily in the form of a cookie or equivalent. An upper gastrointestinal endoscopy and exam including small bowel mucosa biopsy will be performed at the start of the treatment period and again at the end. Blood samples will be routinely taken to evaluate safety and the drug's mechanism of action throughout the study, and symptoms will be recorded using the celiac symptoms index (CSI) survey.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Celiac Disease

Clinical Trial Details

NCT number	NCT04524221
Study type	Interventional
Source	Stanford University
Contact
Status	Completed
Phase	Phase 1
Start date	February 26, 2021
Completion date	April 3, 2022

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