A Blood Based Diagnostic Test for Coeliac Disease

NCT02442219 | Completed

• 1 other identifier: 2011/2472
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Persons with coeliac disease treated with a gluten free diet will be asked to give blood for a new diagnostic blood test. In this test investigators will use multimerized HLA bound to different gliadin-peptides (tetramer) and with the help of a flow-cytometer identify (along with other relevant T-cell-markers) gluten specific T-cells. Investigators believe that these cells will be present in persons with coeliac disease regardless of gluten-intake. Investigators will compare their findings with two control groups; Persons on a gluten free diet where celiac disease is excluded (gluten sensitive group) and persons on a gluten containing diet (healthy control group). In the initial and main study investigators will look at HLA DQ2.5 individuals, which comprise \>90% of all persons with coeliac disease.

Conditions

Coeliac Disease; Non Coeliac Gluten Sensitivity

Keywords

gluten; Tetramer

Outcome Measures

Primary Outcomes (1)

• Ability of the tetramer test in differentiating persons with coeliac disease from controls by the use of tetramer staining for gluten specific T-cells and flowcytometry

  Upto 20 months

Study Arms (3)

Coeliac

Persons with coeliac disease on a gluten free diet where diagnosis is confirmed by duodenal biopsy.

Non coeliac gluten sensitive

Persons on a gluten free diet where coeliac disease is excluded by duodenal biopsy.

Healthy control group

Persons on a gluten containing diet without known coeliac disease.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are invited through announcement in media. Eligibility is tested through HLA-test and previous workup with confirmation / exclusion of coeliac disease by reference method (duodenal biopsy).

You may qualify if:

• HLA DQ2.5 positives in primary blinded study (other HLA-types ie DQ8 and DQ2.2 in later unblinded study)
• In gluten free group: Diagnosis must be confirmed by duodenal biopsy done after sufficient time on gluten containing diet and participant must have followed a glutenfree diet since.

You may not qualify if:

• Drugs that influence the immune system used last three months
• Infected with Hepatitis B, C or HIV
• Pregnant

Sponsors & Collaborators

• Oslo University Hospital: lead
• The Research Council of Norway: collaborator

Study Sites (1)

Oslo University hospital

Oslo, 0372, Norway

Location

Related Publications (1)

• Sarna VK, Lundin KEA, Morkrid L, Qiao SW, Sollid LM, Christophersen A. HLA-DQ-Gluten Tetramer Blood Test Accurately Identifies Patients With and Without Celiac Disease in Absence of Gluten Consumption. Gastroenterology. 2018 Mar;154(4):886-896.e6. doi: 10.1053/j.gastro.2017.11.006. Epub 2017 Nov 14.

  PMID: 29146521 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

A tetramerbased bloodtest which will bind and identify gluten specific T-cells by the use of a flow cytometer. 50 ml blood will be needed for this test, along with characterization of other blood values (eg. Hb, leukocytes, transferrin binding, B12, biobanking etc).

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 Ludin, PhD, MD

  University of Oslo. Oslo University Hospital.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, phD, MD

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: May 13, 2015
• Study Start: February 1, 2015
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

NO (1)