Gluten Challenge in Celiac Disease | NCT02464150

Studies
Gluten Challenge in Celiac Disease

NCT02464150

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Jun 22, 2025Actual

Enrollment

99Actual

Phase

Not Applicable

Conditions

Celiac Disease

Interventions

Gluten challenge

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

May 13, 2025Actual

Completion Date

May 13, 2025Actual

First Submitted Date

Mar 30, 2015

First Submission Date that Met QC Criteria

Jun 4, 2015

First Posted Date

Jun 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2025

Last Update Posted Date

Jun 22, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Knut E. A. Lundin, Professor, M.D., PhD., Consultant gastroenterologist, Oslo University HospitalPrincipal Investigator

Lead Sponsor

Oslo University HospitalOTHER

Collaborators

Name	Class
Stiftelsen Helse og Rehabilitering	OTHER
Helse Sor-Ost	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

99Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants	Experimental	Participants are subjected to gluten intervention in an unblinded fashion.	Dietary Supplement: Gluten challenge

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Transcriptome of gluten-specific T cells	Transcriptional differences of glutenspecific vs. unspecific T cells	Day 6

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Knut EA Lundin, MD PhD	Oslo University Hospital and University of Oslo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo university hospital - Rikshospitalet		Oslo		0372	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31728027	Result	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.
31839959	Result

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases