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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001413415

Enrollment

Registered

2016-10-11

Start date

2016-11-11

Completion date

2024-12-31

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Diagnosis

Masking

Blinded (masking used) (Investigator)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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 criteria

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 .

Outcome results