Pilot Project: The Amplicon and Metatranscriptomic Study of Intra and Extra Intestinal Microbiome in Non-infectious Uveitis Disease

Brief Title

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

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.
    


Study Type

Observational


Primary Outcome

Differential abundant taxonomic groups bacterial

Secondary Outcome

 Detection pathogenic microorganism in samples

Condition

Autoimmune Uveitis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

10

Start Date

November 1, 2019

Completion Date

July 30, 2020

Primary Completion Date

July 30, 2020

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Ratna Sitompul, Professor, +628118009911, [email protected]

Location Countries

Indonesia

Location Countries

Indonesia

Administrative Informations


NCT ID

NCT04126850

Organization ID

19-05-0624


Responsible Party

Principal Investigator

Study Sponsor

Fakultas Kedokteran Universitas Indonesia


Study Sponsor

Ratna Sitompul, Professor, Principal Investigator, RSUPN dr. Cipto Mangunkusumo Hospital (RSCM)


Verification Date

October 2019