AzTrials
AzTrials

Celiac DiseaseNCT02464150

Gluten Challenge in Celiac Disease

A study testing Gluten challenge in people with Celiac Disease, run by Oslo University Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Celiac Disease
What is being tested?
Gluten challenge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteNorway
Study dates
1 Apr 2017to 13 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Norway1 site

  • Oslo university hospital - Rikshospitalet

    Oslo, 0372

Other trials in Norway

About this study

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.

Read the 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.

Conditions
Celiac Disease
Being tested
Gluten challenge
Keywords
gluten, antigen-specific T cells, transcriptome
Medical subject headings
Celiac Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gluten challengeDietary supplement

    Challenge done in the form of a gluten containing cookie once daily, or up to four slices of regular bread daily.

Study groups in NCT02464150
Study groupRoleWhat they receive
ParticipantsExperimentalParticipants are subjected to gluten intervention in an unblinded fashion.
Receives: Dietary Supplement: Gluten challenge

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Transcriptome of gluten-specific T cells

    Transcriptional differences of glutenspecific vs. unspecific T cells

    Measured: Day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2015 (estimated)
  2. Study start1 Apr 2017
  3. Primary completion13 May 2025
  4. Study completion13 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02464150
Sponsor's protocol ID
2013/1237
Status last verified
Jun 2025
First submitted
30 Mar 2015
Last updated
22 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Eggesbo LM, Risnes LF, Neumann RS, Lundin KEA, Christophersen A, Sollid LM. Single-cell TCR sequencing of gut intraepithelial gammadelta T cells reveals a vast and diverse repertoire in celiac disease. Mucosal Immunol. 2020 Mar;13(2):313-321. doi: 10.1038/s41385-019-0222-9. Epub 2019 Nov 14.

    PubMed 31728027

  • 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.

    PubMed 31839959

  • Risnes LF, Eggesbo LM, Zuhlke S, Dahal-Koirala S, Neumann RS, Lundin KEA, Christophersen A, Sollid LM. Circulating CD103+ gammadelta and CD8+ T cells are clonally shared with tissue-resident intraepithelial lymphocytes in celiac disease. Mucosal Immunol. 2021 Jul;14(4):842-851. doi: 10.1038/s41385-021-00385-8. Epub 2021 Mar 2.

    PubMed 33654213

  • Dahal-Koirala S, Risnes LF, Neumann RS, Christophersen A, Lundin KEA, Sandve GK, Qiao SW, Sollid LM. Comprehensive Analysis of CDR3 Sequences in Gluten-Specific T-Cell Receptors Reveals a Dominant R-Motif and Several New Minor Motifs. Front Immunol. 2021 Apr 13;12:639672. doi: 10.3389/fimmu.2021.639672. eCollection 2021.

    PubMed 33927715

  • Christophersen A, Zuhlke S, Lund EG, Snir O, Dahal-Koirala S, Risnes LF, Jahnsen J, Lundin KEA, Sollid LM. Pathogenic T Cells in Celiac Disease Change Phenotype on Gluten Challenge: Implications for T-Cell-Directed Therapies. Adv Sci (Weinh). 2021 Nov;8(21):e2102778. doi: 10.1002/advs.202102778. Epub 2021 Sep 8.

    PubMed 34495570

  • Christophersen A, Zuhlke S, Lund EG, Snir O, Dahal-Koirala S, Risnes LF, Jahnsen J, Lundin KEA, Sollid LM. Pathogenic T Cells in Celiac Disease Change Phenotype on Gluten Challenge: Implications for T-Cell-Directed Therapies. Adv Sci (Weinh). 2022 Dec;9(34):e2205912. doi: 10.1002/advs.202205912. No abstract available.

    PubMed 36482157

  • Stamnaes J, Stray D, Stensland M, Sarna VK, Nyman TA, Lundin KEA, Sollid LM. In Well-Treated Celiac Patients Low-Level Mucosal Inflammation Predicts Response to 14-day Gluten Challenge. Adv Sci (Weinh). 2021 Jan 4;8(4):2003526. doi: 10.1002/advs.202003526. eCollection 2021 Feb.

    PubMed 33643806

  • Tye-Din JA, Skodje GI, Sarna VK, Dzuris JL, Russell AK, Goel G, Wang S, Goldstein KE, Williams LJ, Sollid LM, Lundin KE, Anderson RP. Cytokine release after gluten ingestion differentiates coeliac disease from self-reported gluten sensitivity. United European Gastroenterol J. 2020 Feb;8(1):108-118. doi: 10.1177/2050640619874173. Epub 2019 Sep 3.

    PubMed 32213060

  • Goel G, Tye-Din JA, Qiao SW, Russell AK, Mayassi T, Ciszewski C, Sarna VK, Wang S, Goldstein KE, Dzuris JL, Williams LJ, Xavier RJ, Lundin KEA, Jabri B, Sollid LM, Anderson RP. Cytokine release and gastrointestinal symptoms after gluten challenge in celiac disease. Sci Adv. 2019 Aug 7;5(8):eaaw7756. doi: 10.1126/sciadv.aaw7756. eCollection 2019 Aug.

    PubMed 31457091

  • Risnes LF, Christophersen A, Dahal-Koirala S, Neumann RS, Sandve GK, Sarna VK, Lundin KE, Qiao SW, Sollid LM. Disease-driving CD4+ T cell clonotypes persist for decades in celiac disease. J Clin Invest. 2018 Jun 1;128(6):2642-2650. doi: 10.1172/JCI98819. Epub 2018 May 14.

    PubMed 29757191

  • Dahal-Koirala S, Risnes LF, Christophersen A, Sarna VK, Lundin KE, Sollid LM, Qiao SW. TCR sequencing of single cells reactive to DQ2.5-glia-alpha2 and DQ2.5-glia-omega2 reveals clonal expansion and epitope-specific V-gene usage. Mucosal Immunol. 2016 May;9(3):587-96. doi: 10.1038/mi.2015.147. Epub 2016 Feb 3.

    PubMed 26838051

  • 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.

    PubMed 29102613

  • 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.

    PubMed 28779027

  • Herfindal AM, Nilsen M, Aspholm TE, Schultz GIG, Valeur J, Rudi K, Thoresen M, Lundin KEA, Henriksen C, Bohn SK. Effects of fructan and gluten on gut microbiota in individuals with self-reported non-celiac gluten/wheat sensitivity-a randomised controlled crossover trial. BMC Med. 2024 Sep 4;22(1):358. doi: 10.1186/s12916-024-03562-1.

    PubMed 39227818

Questions about this trial

What is this clinical trial studying?

A study testing Gluten challenge in people with Celiac Disease, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transcriptome of gluten-specific T cells (time frame: Day 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02464150, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025; AzTrials last refreshed its copy on 29 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in