Gluten Challenge in Celiac Disease

NCT02464150 | Completed

• 1 other identifier: 2013/1237
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease

Keywords

gluten; antigen-specific T cells; transcriptome

Outcome Measures

Primary Outcomes (1)

• Transcriptome of gluten-specific T cells

  Transcriptional differences of glutenspecific vs. unspecific T cells

  Day 6

Study Arms (1)

Participants

EXPERIMENTAL

Participants are subjected to gluten intervention in an unblinded fashion.

Dietary Supplement: Gluten challenge

Interventions

Gluten challenge DIETARY_SUPPLEMENT

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

Participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Stiftelsen Helse og Rehabilitering: collaborator
• Helse Sor-Ost: collaborator

Study Sites (1)

Oslo university hospital - Rikshospitalet

Oslo, 0372, Norway

Location

Related Publications (14)

• 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.

  PMID: 31728027 RESULT

• 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.

  PMID: 31839959 RESULT

• 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.

  PMID: 33654213 RESULT

• 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.

  PMID: 33927715 RESULT

• 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.

  PMID: 34495570 RESULT

• 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.

  PMID: 36482157 RESULT

• 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.

  PMID: 33643806 RESULT

• 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.

  PMID: 32213060 RESULT

• 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.

  PMID: 31457091 RESULT

• 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.

  PMID: 29757191 RESULT

• 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.

  PMID: 26838051 RESULT

• 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.

  PMID: 29102613 RESULT

• 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.

  PMID: 28779027 RESULT

• 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.

  PMID: 39227818 DERIVED

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Knut EA Lundin, MD PhD

  Oslo University Hospital and University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, M.D., PhD., Consultant gastroenterologist

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: June 8, 2015
• Study Start: April 1, 2017
• Primary Completion: May 13, 2025
• Study Completion: May 13, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

NO (1)