An observational study in Development and Validation of Gut Permeability Sensor, Permeability; Increased and Celiac Disease, sponsored by Imperial College London. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-12.
Sponsored by Imperial College London · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 21 studies in Celiac Disease with a site in United Kingdom — 4 open to participants now, 5 under way, none of them phase 3. Celiac Disease · United Kingdom.
Among the 21 studies in Celiac Disease with a site in United Kingdom, this one is the only one that started in 2019, is one of 8 observational ones, and was the 9th registered.
352 studies on the registry are indexed under Celiac Disease; 77 are open to participants now.
Browse Celiac Disease studies →4 of the 21 studies in Celiac Disease with a site in United Kingdom are open now. Recruiting first, the newest first:
Sheffield Teaching Hospitals NHS Foundation Trust · Sites in United Kingdom
Ages 18–65
Sheffield Teaching Hospitals NHS Foundation Trust · Sites in United Kingdom
Ages 18+
King's College London · Sites in United Kingdom
Ages 18+
University of Surrey · Sites in United Kingdom
Ages 7–11
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 48 Celiac Disease studies recruiting now, 24 (50%) set no upper age limit and 19 (40%) stop at 75 or younger; 16 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2019.
This study's planned enrollment of 50 is below the median of 185 across 134 observational studies indexed under Celiac Disease.
Median enrollment 95 across the 13 interventional studies, 86 across the 8 observational. Of the 14 that completed or were terminated, 2 (14%) have results posted.
This tab as a report to print or save as PDF → With an account.
6 of 21 have an industry lead sponsor. The 10 most frequent:
Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Imperial College London has 1 study filed under Celiac Disease — fewer than ten, so there is no comparison to draw.
1 of the studies in Celiac Disease with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07172555Sheffield Teaching Hospitals NHS Foundation TrustVirtual Dietetic Interventions in Patients With Coeliac | 2027-06-15 |
Add it to your calendar (.ics) → With an account.
Among the 21 studies in Celiac Disease with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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 leakiness (permeability) of the gut in a non-invasive manner and will provide an early warning that patients are at risk of infections caused by the unwanted flow of bacteria from the intestine to the rest of the body.
"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 condition is associated with many widespread diseases including coeliac disease, inflammatory bowel disease, HIV, liver cirrhosis, sepsis and environmental enteric dysfunction (EED). It has a considerable impact on quality of life and, in extreme cases (e.g. sepsis), it can even lead to death. Furthermore, in the developing world (as part of EED), it severely hampers the mental and physical development of young children. Thus, new devices that can help us to learn more about leaky gut and more accurately monitor its effects are urgently needed.
In this project, patients will drink a small dose of a fluorescent dye. Then, by shining light on the patients' skin and recording the color and brightness of the light (fluorescence) that comes back, it will be possible to measure the amount of dye that has leaked into the blood (indicating the likelihood that bacteria are escaping from the gut and causing infections). We refer to this as a "Spectroscopic gut permeability test." We will also ask patients to take a traditional permeability test (known as a PEG permeability test) so that we can validate our new sensor. Overall, this research will deliver vital information that will improve our understanding of leaky gut and help guide the development of treatments for the many diseases in which it occurs.
Potential participants will be identified and approached by members of their healthcare/clinical team. They will be identified based on their clinical condition and its potential relevance to the study - i.e. ophthalmology patients due to receive intravenous doses of fluorescein or ICG for Stage 1; GI and non-GI patients exhibiting increased intestinal permeability for Stages 2 and 3.
Healthy volunteers with no indication of increased intestinal permeability will be recruited from Imperial College and St. Mary's Hospital staff. Potential healthy volunteers will be approached in person by members of the research team.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ophthalmology patients who are receiving an intravenous dose of either fluorescein or indocyanine green (ICG) as part of their routine ophthalmic care (e.g. as part of a fluorescence angiography examination) will be recruited to the first stage of this study. These patients will take part in preliminary studies aimed at determining whether it is possible to detect fluorescein and ICG in the blood using transcutaneous fluorescence measurements.
Diagnostic Test: Spectroscopic gut permeability test
Healthy subjects with no known issues of increased gut permeability. These subjects will act as negative controls in all gut permeability studies.
Diagnostic Test: Spectroscopic gut permeability test
A subset of healthy volunteers will be recruited to take part in experiments to help in understanding the impact of gastric emptying rate as a confounding factor in measurements of gut permeability.
Diagnostic Test: Spectroscopic gut permeability test
Gastro-intestinal (GI) and non-GI patients who are expected to exhibit increased gut permeability (e.g. patients with celiac disease, inflammatory bowel disease (IBD), liver disease, HIV or another condition in which increased intestinal permeability is common). The more extreme cases in this group will act as positive controls.
Diagnostic Test: Spectroscopic gut permeability test
The spectroscopic gut permeability test first involves patients receiving an oral dose of one or more fluorescent dyes. A wearable sensor will then be attached to the patients' skin and this will be used to monitor the leakage of the fluorescent dyes from the intestine into the blood stream in a non-invasive manner. In this way, a measure of the permeability of the intestine will be obtained. Note that patients in Group 1 (ophthalmology patients) will not receive oral doses of contrast agents. Instead, the wearable sensor will simply be used to detect the presence of fluorescent dyes that were administered intravenously as part of planned ophthalmic procedures. Complete details of the spectroscopic gut permeability test can be found in the attached protocol.
Blood concentration from intravenous injection
Where the blood concentration of fluorescent dye is known - for example, in ophthalmology patients who have received a direct intravenous dose of contrast agent - a direct comparison will be made between these values and the results of the spectroscopic gut permeability test without the need for further measurements.
Time frame: 1 day (study visit)
Blood concentration from samples
In subjects receiving an oral dose of contrast agent, blood samples will be taken alongside the spectroscopic measurements in order to permit accurate ex vivo quantification of the serum concentration in the laboratory. These values will be compared with the spectroscopic findings.
Time frame: 1 day (study visit)
PEG permeability assay
In patients who are also undergoing polyethylene glycol (PEG)-based permeability assays, spectroscopic permeability measurements will be compared to the results of this more traditional approach.
Time frame: 1 week (after study visit)
Histology
Finally, in patients for whom intestinal biopsy and histology data is available, spectroscopic permeability measurements will be compared against histological measures of epithelial damage and permeability.
Time frame: 1 day (study visit)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Anonymized participant data will be made available to other researchers once the final results of the study have been published.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data will be made available once the final results of the study have been published. Data relevant to publications will be available indefinitely through a data repository. Additional data will be held on secure servers at Imperial College London for 10 years from the completion of the study.
Access criteria: Data relevant to publications will be made available in an open access manner through data repositories. Additional data will be stored securely at Imperial College London for 10 years. Other researchers can request access to this data through the study chief investigator. This will be granted assuming that appropriate ethical approvals have been obtained.
Started Mar 2019 (actual). Primary completion is estimated for Sep 2021, 30 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.