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NCT02464150 Clinical Trial

Gluten Challenge in Celiac Disease

Celiac Disease Clinical Trial

Official title:
Gluten Challenge in Celiac Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02464150
Other study ID # 2013/1237
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2017
Est. completion date August 2028

Study information
Verified date July 2020
Source Oslo University Hospital
Contact Stephanie Zühlke, MD
Phone 23074224
Email stephanie.zuhlke@medisin.uio.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Up till 30 participants with celiac disease on a glutenfree diet are asked to consume gluten containing cookies or bread for 3 days.

Questionnaires and sampling of blood is done before, during and after.

Description:

Before and 6 days after start of gluten challenge, blood samples will be collected and analysed by using HLA-tetramers to identify and purify CD4+ gluten-specific T cells by flow cytometry. T cells will undergo transcriptome analysis to get an insight in signalling of antigen-specific cells. Other cell populations like CD8+ T cells and γδ T cells will also be analyzed by flow cytometry.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date August 2028
Est. primary completion date August 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Celiac disease confirmed by biopsy

- Age 18 - 80 years

- Gluten free diet last 6 months

- Subject has received information and signed the informed consent form

Exclusion Criteria:

- Pregnant or breast feeding

- Probability of participant becoming pregnant (f.ex. by not using adequate sexual prevention by woman in fertile age)

- Drugs influencing immune system used last 3 months

- Current infectious disease of moderate or high severity

- Other chronic active intestinal disease

- Serious reaction on small amounts of gluten ingested

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Gluten challenge
Challenge done in the form of a gluten containing cookie once daily, or up to four slices of regular bread daily.

Locations
Country Name City State
Norway Oslo university hospital - Rikshospitalet Oslo

Sponsors (3)
Lead Sponsor Collaborator
Oslo University Hospital Helse Sor-Ost, Stiftelsen Helse og Rehabilitering

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Transcriptome of gluten-specific T cells Transcriptional differences of glutenspecific vs. unspecific T cells Day 6
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