Clinical trial NCT04126850: Pilot Project: The Amplicon and Metatranscriptomic Study of Intra and Extra Intestinal Microbiome in Non-infectious Uveitis Disease
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autoimmune Uveitis
Behçet Disease
Vogt-Koyanagi-Harada Disease
Idiopathic Uveitis
Noninfectious Panuveitis
Anterior Uveitis Idiopathic
Posterior Uveitis
Intermediate Uveitis
Keywords: Microbiome
Autoimmune Uveitis
Vogt-Koyanagi-Harada Disease
Behçet Disease
Idiopathic Uveitis
Metatranscriptomic
Amplicon
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-infectious and idiopathic uveitis patients registered from November 2019 at Cipto Mangunkusumo Hospital, Indonesia.

Brief 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

Detailed description: Gut microbiome has been widely studied around the globe, and it is convinced that the gut microbiome plays an essential role in many human diseases. In a published review showed the presence of microbes in blood from a patient who suffered from non-communicable disease. The microbes present in dormant or not-immediately-culturable states as if blood is a 'sterile' environment. It was argued that the difficulty of culturing microbes from the blood was coming from the limited understanding of suitable growth/isolation media for the microbes to be cultured. This limitation can be overcome by the sequenced-based methods for detecting non-proliferating microbes. The presence of microbes in blood also can be observed by ultrastructural (microscopic) methods. Through the microscopic observations, it was witnessing the presence of coccus and bacillus shaped bacteria that present proximity to (Red Blood Cell) RBCs in sample blood patients with Alzheimer's or Parkinson's Disease. The presence of microbes in the places other than their normal location state by term 'atopobiosis'. The presence of microbes in blood suspected as a result of translocation between the gut to the blood.

Therefore, according to the current knowledge of microbiome association and the human diseases, we are eager to conduct a pilot project that gives a comprehensive picture of the association between the microbiome and uveitis disease partially non-infectious and idiopathic uveitis. We will investigate microbiome profiling in the intestinal and extra-intestinal of uveitis patients before and after treatment to see whether any alteration of microbial abundance at two distinct clinical conditions partially in uveitis patients with history of autoimmune disease (Behcet and Vogt-Koyanagi-Harada) and idiopathic uveitis. Another objective of this study is to explore any pathogenic microorganism that present in uveitis patients samples conducted by a sequenced-based method.

Eligibility criteria: 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

Primary outcomes:
measure: Differential abundant taxonomic groups bacterial
timeFrame: 0, 6 weeks
Secondary outcomes:
measure: Detection pathogenic microorganism in samples
timeFrame: 0, 6 weeks
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
state: Jakarta
Study officials:
affiliation: RSUPN dr. Cipto Mangunkusumo Hospital (RSCM)
name: Ratna Sitompul, Professor
role: PRINCIPAL_INVESTIGATOR
References: