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

Plain Language Summary

Simplified for easier understanding

This study is testing whether light-based techniques — such as Raman, infrared, and fluorescence spectroscopy — can detect coeliac disease in tissue samples taken during a routine gastroscopy. Coeliac disease is a condition where eating gluten damages the lining of the small intestine. Currently, diagnosis requires a biopsy and lab testing. This research aims to develop a faster, point-of-care tool that could be used during the procedure itself. You may be eligible if: - You are 16 years of age or older - You are already scheduled for a gastroscopy (stomach scope) for any reason - You are willing to have 2 to 4 additional small tissue samples (biopsies) taken during the procedure You may NOT be eligible if: - You are under 16 years of age - You have a bleeding disorder - You are taking blood-thinning (anticoagulant) medications - You have a severely weakened immune system Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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ACTRN12616001413415


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