Gluten Challenge in Celiac Disease

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02464150
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Oslo University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Knut EA Lundin, MD PhD
Principal Investigator Affiliation	Oslo University Hospital and University of Oslo
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Norway
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Celiac Disease

Additional Details

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.

Arms & Interventions

Arms

Experimental: Participants

Participants are subjected to gluten intervention in an unblinded fashion.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Oslo, Norway

Status

Recruiting

Address

Oslo university hospital - Rikshospitalet

Oslo, , 0372

Site Contact

Stephanie Zühlke, M.D.

stephanie.zuhlke@medisin.uio.no

23074224

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