Status:
COMPLETED
Assessment of Immune Activation and Tolerance in Celiac Disease During Gluten Challenge
Lead Sponsor:
Takeda
Conditions:
Celiac Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The primary purpose of this study is to characterize changes in gluten-specific T cells and pathology in the small intestine with specific focus on biomarkers likely to change with therapeutic celiac ...
Detailed Description
Gluten challenge studies are used to test the effectiveness of therapies designed to prevent immune response to gluten in participants with CeD. The study will enroll approximately 20 participants. Pa...
Eligibility Criteria
Inclusion
- Be a non-smoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before Day 1 gluten administration.
- Have well-controlled biopsy-proven CeD, compliant with a gluten-free diet (GFD) for greater than or equal to (\>=) 6 months preceding screening, with resolution of CeD symptoms, normalization of CeD serology, and in the judgment of the investigator, have inactive or minimally-active disease.
- Be HLA-DQ2.5 and/or HLA-DQ8 positive, assessed at screening. If participants have already been genotyped, results from previous testing may be used in lieu of genotyping at screening.
- Be willing to delay a planned procedure involving the use of powerful electromagnetic fields (example, magnetic resonance imaging), until the PillCam SB 3 capsule is excreted.
- Not undergo VCE or optical coherence tomography (OCT) if has an implanted electromedical device or a swallowing disorder.
- Not undergo OCT if has a contraindication to the device or procedure as per reference information.
Exclusion
- Had major surgery and/or donated or lost 1 unit of blood (approximately 500 milliliter \[mL\]) within 8 weeks before the first dose of gluten.
- Are unable to refrain from or anticipate the use of any unapproved medication, including prescription drugs, nonprescription drugs, and herbal remedies, beginning approximately 7 days before administration of the initial dose of gluten and continuing throughout the trial until the follow-up visit.
- Consume excessive amounts of coffee, tea, cola, energy drinks, or other caffeinated beverages per day. An excessive amount is defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine).
- Have positive IgA anti-tissue transglutaminase (tTG), IgA anti-deamidated gliadin peptide (DGP), and IgG DGP serologies at Screening.
- Have inflammatory gastrointestinal disorders or autoimmune diseases other than CeD or autoimmune thyroid disease.
- Have known or suspected gastrointestinal obstructions, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile of the PillCam SB 3 capsule.
- Endoscopy and intestinal biopsy are contraindicated.
Key Trial Info
Start Date :
April 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03409796
Start Date
April 24 2018
End Date
May 2 2019
Last Update
May 24 2022
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215