RecruitingACTRN12616001413415

An ex vivo investigation into diagnosis of coeliac disease by multiple light-based methods. A proof of principle study towards future development of an in vivo point of care diagnosis device.

An ex vivo investigation into diagnosis of coeliac disease by multiple spectroscopic methods. A proof of principle study towards development of an in vivo point of care diagnosis device.


Sponsor

Dunedin School of Medicine, University of Otago

Enrollment

95 participants

Start Date

Nov 11, 2016

Study Type

Interventional

Conditions

Summary

The purpose of this study is to determine if spectroscopic (light-based) techniques such as Raman, infrared and fluorescence spectroscopy can be used to detect illnesses of the gastrointestinal tract. The model illness studied here is coeliac disease to determine if any one or a combination of these spectroscopic techniques can differentiate diseased from healthy tissue with high sensitivity and selectivity. Should this study give promising results then future work will involve the development of a spectroscopic probe for point of care diagnosis during a gastroscopy.


Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Inclusion Criteria1

  • Patients already undergoing a gastroscopy for either coeliac disease detection or an unrelated reason (control) are invited for inclusion in this study so that the risk of inclusion in the study is associated with an additional 2-4 biopsies collected rather than the gastroscopic procedure itself.

Exclusion Criteria2

  • Minors are excluded from this study.
  • To minimise the risk of bleeding or infection due to biopsy, patients who are at risk of these complications are excluded from this study such as patients with bleeding disorders, taking anticoagulation medicine or patients who are severely immunocompromised .

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Interventions

During a gastroscopy procedure (that the patient is already undertaking) an additional 2-4 biopsies will be collected from the duodenum. These additional biopsies will be analysed spectroscopically fo

During a gastroscopy procedure (that the patient is already undertaking) an additional 2-4 biopsies will be collected from the duodenum. These additional biopsies will be analysed spectroscopically followed by standard histological analysis for diagnosis of coeliac disease. The spectroscopic techniques to be carried out on the biopsied tissue include Raman, near-infrared, mid-infrared and fluorescence spectroscopy. These biopsies will be used to determine if a particular form or combination of spectroscopic techniques is a valid potential method for diagnosis of gastrointestinal illnesses. This procedure will only occur once per patient and should not interfere with the reason for undertaking the gastroscopy and any subsequent diagnoses in the first place. In addition patients will be asked some questions relating to their medical history and medication to check for interfering variables.


Locations(1)

Otago, New Zealand

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