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Gluten Challenge in Celiac Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02464150
Recruitment Status : Recruiting
First Posted : June 8, 2015
Last Update Posted : July 14, 2020
Sponsor:
Collaborators:
Stiftelsen Helse og Rehabilitering
Helse Sor-Ost
Information provided by (Responsible Party):
Knut E. A. Lundin, Oslo University Hospital

Study Description
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Brief 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.


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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
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 : August 2028
Estimated Study Completion Date : August 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arms and Interventions
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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, or up to four slices of regular bread daily.


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


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

Locations
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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
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Principal Investigator: Knut EA Lundin, MD PhD Oslo University Hospital and University of Oslo
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Knut E. A. Lundin, Professor, M.D., PhD., Consultant gastroenterologist, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02464150    
Other Study ID Numbers: 2013/1237
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020

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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:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases