Pilot Project: The Amplicon and Metatranscriptomic Study of Intra and Extra Intestinal Microbiome… (NCT04126850) | Clinical Trial Compass
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Pilot Project: The Amplicon and Metatranscriptomic Study of Intra and Extra Intestinal Microbiome in Non-infectious Uveitis Disease
Indonesia10 participantsStarted 2019-11-01
Plain-language summary
This study aimed to discover the composition on the microbiome in several sites of the human body; and to find out the difference in microbiome composition on ocular fluid, blood, and feces before and after therapy in uveitis patient with history of autoimmune disease (Behcet and Vogt-Koyanagi-Harada) and idiopathic uveitis
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* New patient registered at Cipto Mangunkusumo Hospital since November 2019
* Patient diagnosed with non-infectious uveitis (with Behcet, VKH history)
* Patient idiopathic uveitis (proven to have negative result by available etiological uveitis work-ups)
* Minimum age: 18 years old
* Experience active inflammation in the past 180 days and or during patient registration following Standard Uveitis Nomenclature (SUN) guidelines, in at least:
* equal and or more than 2+ anterior chamber cells
* equal and or more than 2+ vitreous haze and/or
* active retinal/choroidal lesions
Exclusion Criteria:
* patients had taken probiotics supplement or antibiotics 3 months before sample collection
* or who experience prolonged diarrhea or constipation
* or undergone gastrointestinal surgery
* having any form of malignancy
* having a systemic disease such as hypertension, obesity, inflammatory bowel disease, or diabetes.
* Disagree to sign informed consent
* Uveitis is proven to be an infectious origin
* Pregnant patient
* Loss to follow up patient
Healthy volunteers are recruited for this study after giving consent with the following inclusion criteria:
* age: 18-50 years old (Man/Woman)
* having no health complaints or symptoms
* not in any long term medications
* having no history of allergy
* willing to cooperate in the study
* state of complete physical, mental and social well being
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.