Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - 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 Criteria:- 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)
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Imperial College London|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Alex J Thompson, PhD|
|Principal Investigator Affiliation||Imperial College London|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Development and Validation of Gut Permeability Sensor, Permeability; Increased, Celiac Disease, Inflammatory Bowel Diseases, Liver Diseases, HIV/AIDS|
Full study details can be found in the attached study protocol.
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Alex J Thompson, PhD
For additional contact information, you can also visit the trial on clinicaltrials.gov.