Status:
UNKNOWN
Fluorescence Spectroscopy for Gut Permeability Assessment
Lead Sponsor:
Imperial College London
Conditions:
Development and Validation of Gut Permeability Sensor
Permeability; Increased
Eligibility:
All Genders
18+ years
Brief Summary
This research aims to develop portable devices - known as fluorescence spectrometers - to monitor the leakage of fluorescent dyes out of the gut into the blood stream. These devices will measure the l...
Detailed Description
"Leaky gut" - or, increased permeability of the intestine - involves the leakage of certain intestinal constituents (e.g. endotoxins or even bacteria) from the gut into the rest of the body. This cond...
Eligibility Criteria
Inclusion
- Ability to give informed consent
- Aged 18 years or above
- No evidence of prior adverse reactions to fluorescein, ICG, dextran or PEG
- No evidence of prior adverse reactions to iodine (for ICG experiments only)
- For healthy volunteers: healthy with no active GI/liver disease (or other condition in which increased gut permeability is expected, e.g. HIV) and no antibiotics taken within the previous four weeks.
- For cases: exhibiting symptoms of GI, liver or other diseases (e.g. HIV) in which increased intestinal permeability is expected.
- For ophthalmology patients recruited in Stage 1: healthy (i.e. as described above for healthy volunteers) and prescribed to have an ophthalmic angiography with an intravenous injection of either fluorescein or ICG.
Exclusion
- Unable to give informed consent
- Aged \<18 years
- Previous adverse reaction to fluorescein, ICG, dextran or PEG
- Known allergy to iodine (for ICG experiments only)
- Pregnancy (in Stage 1 this will be at the discretion of the patient's ophthalmologist)
- Breastfeeding (in Stage 1 this will be at the discretion of the ophthalmologist)
Key Trial Info
Start Date :
March 29 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03434639
Start Date
March 29 2019
End Date
September 30 2021
Last Update
February 12 2020
Active Locations (1)
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1
IMPERIAL COLLEGE Healthcare Trust
London, United Kingdom, W2 1NY