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Gluten Challenge in Celiac Disease

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ClinicalTrials.gov Identifier: NCT02464150
Recruitment Status : Recruiting
First Posted : June 8, 2015
Last Update Posted : May 30, 2017
Sponsor:
Collaborators:
Stiftelsen Helse og Rehabilitering
Helse Sor-Ost
Information provided by (Responsible Party):
Knut E. A. Lundin, Oslo University Hospital

Brief Summary:

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

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


Condition or disease Intervention/treatment Phase
Celiac Disease Dietary Supplement: Gluten challenge Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Gluten Challenge in Celiac Disease
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Experimental: Participants
Participants are subjected to gluten intervention in an unblinded fashion.
Dietary Supplement: Gluten challenge
Challenge done in the form of a gluten containing cookie once daily.




Primary Outcome Measures :
  1. Transcriptome of gluten-specific T cells [ Time Frame: Day 6 ]
    Transcriptional differences of glutenspecific vs. unspecific T cells



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464150


Contacts
Contact: Stephanie Zühlke, MD 23074224 ext +47 stephanie.zuhlke@medisin.uio.no

Locations
Norway
Oslo university hospital - Rikshospitalet Recruiting
Oslo, Norway, 0372
Contact: Stephanie Zühlke, M.D.       stephanie.zuhlke@medisin.uio.no   
Sponsors and Collaborators
Oslo University Hospital
Stiftelsen Helse og Rehabilitering
Helse Sor-Ost
Investigators
Principal Investigator: Knut EA Lundin, PhD associate professor MD Oslo University Hospital and University of Oslo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Knut E. A. Lundin, Associate professor, dr. med., M.D., Consultant physician, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02464150     History of Changes
Other Study ID Numbers: 2013/1237
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Knut E. A. Lundin, Oslo University Hospital:
gluten
antigen-specific T cells
transcriptome

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases