Behçet Disease Clinical Trial
Official title:
Pilot Project: The Amplicon and Metatranscriptomic Next-generation Sequencing of Samples From Intra and Extra-intestinal Microbiome in Non-infectious Uveitis Patients to Decipher Possibility Uveitis Pathogenesis
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
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | July 30, 2020 |
Est. primary completion date | July 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Indonesia | RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital) | Jakarta Pusat | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Fakultas Kedokteran Universitas Indonesia |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differential abundant taxonomic groups bacterial | The primer used in this amplicon study is targeted to 16S rRNA gene region V3-V4 to detect bacterial diversity in the samples. The sequencing will be generated by Illumina according to standard protocol. Prior filter is conducted using Prinseq-lite, then chimeric sequences remove using Usearch61 and left over the high quality reads. The (operational taxonomic unit) OTU is picked using bioinformatic tool (Quantitative Insights Into Microbial Ecology - QIIME). Taxonomic classification for de novo OTUs clustering will be generated using open source software package for bioinformatics data processing. Shanon diversity, Simpson index will be examined for calculating alpha diversity. And then we will do identification of differential abundant taxonomic groups. And do analysis correlation network between bacterial genera among two clinical condition (before and after received oral steroid) relatively to health control. | 0, 6 weeks | |
Secondary | Detection pathogenic microorganism in samples | In this study we are going to use IDseq Portal, a novel bioinformatics platform that designed for detection of microbes from metagenomic data. This analysis will be applied in all types samples (stool, blood, and aqueous humor). We expect to find any specific microbiome (bacterial/fungal/virus) signature in samples patient uveitis. | 0, 6 weeks |
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