search
Back to results

Gluten Challenge in Celiac Disease

Primary Purpose

Celiac Disease

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Gluten challenge
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Celiac Disease focused on measuring gluten, antigen-specific T cells, transcriptome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo university hospital - RikshospitaletRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants

Arm Description

Participants are subjected to gluten intervention in an unblinded fashion.

Outcomes

Primary Outcome Measures

Transcriptome of gluten-specific T cells
Transcriptional differences of glutenspecific vs. unspecific T cells

Secondary Outcome Measures

Full Information

First Posted
March 30, 2015
Last Updated
July 12, 2020
Sponsor
Oslo University Hospital
Collaborators
Stiftelsen Helse og Rehabilitering, Helse Sor-Ost
search

1. Study Identification

Unique Protocol Identification Number
NCT02464150
Brief Title
Gluten Challenge in Celiac Disease
Official Title
Gluten Challenge in Celiac Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
August 2028 (Anticipated)
Study Completion Date
August 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Stiftelsen Helse og Rehabilitering, Helse Sor-Ost

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
gluten, antigen-specific T cells, transcriptome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants
Arm Type
Experimental
Arm Description
Participants are subjected to gluten intervention in an unblinded fashion.
Intervention Type
Dietary Supplement
Intervention Name(s)
Gluten challenge
Intervention Description
Challenge done in the form of a gluten containing cookie once daily, or up to four slices of regular bread daily.
Primary Outcome Measure Information:
Title
Transcriptome of gluten-specific T cells
Description
Transcriptional differences of glutenspecific vs. unspecific T cells
Time Frame
Day 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Zühlke, MD
Phone
23074224
Ext
+47
Email
stephanie.zuhlke@medisin.uio.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Knut EA Lundin, MD PhD
Organizational Affiliation
Oslo University Hospital and University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo university hospital - Rikshospitalet
City
Oslo
ZIP/Postal Code
0372
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Zühlke, M.D.
Email
stephanie.zuhlke@medisin.uio.no

12. IPD Sharing Statement

Citations:
PubMed Identifier
31839959
Citation
Zuhlke S, Risnes LF, Dahal-Koirala S, Christophersen A, Sollid LM, Lundin KE. CD38 expression on gluten-specific T cells is a robust marker of gluten re-exposure in coeliac disease. United European Gastroenterol J. 2019 Dec;7(10):1337-1344. doi: 10.1177/2050640619874183. Epub 2019 Sep 7.
Results Reference
derived
PubMed Identifier
29102613
Citation
Skodje GI, Sarna VK, Minelle IH, Rolfsen KL, Muir JG, Gibson PR, Veierod MB, Henriksen C, Lundin KEA. Fructan, Rather Than Gluten, Induces Symptoms in Patients With Self-Reported Non-Celiac Gluten Sensitivity. Gastroenterology. 2018 Feb;154(3):529-539.e2. doi: 10.1053/j.gastro.2017.10.040. Epub 2017 Nov 2.
Results Reference
derived
PubMed Identifier
28779027
Citation
Sarna VK, Skodje GI, Reims HM, Risnes LF, Dahal-Koirala S, Sollid LM, Lundin KEA. HLA-DQ:gluten tetramer test in blood gives better detection of coeliac patients than biopsy after 14-day gluten challenge. Gut. 2018 Sep;67(9):1606-1613. doi: 10.1136/gutjnl-2017-314461. Epub 2017 Aug 4.
Results Reference
derived

Learn more about this trial

Gluten Challenge in Celiac Disease

We'll reach out to this number within 24 hrs