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

October 15, 2019 updated by: Ratna Sitompul, Fakultas Kedokteran Universitas Indonesia

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

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
    • Jakarta
      • Jakarta Pusat, Jakarta, Indonesia, 10320

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Non-infectious and idiopathic uveitis patients registered from November 2019 at Cipto Mangunkusumo Hospital, Indonesia.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differential abundant taxonomic groups bacterial
Time Frame: 0, 6 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection pathogenic microorganism in samples
Time Frame: 0, 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fakultas Kedokteran Universitas Indonesia

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2019

Primary Completion (ANTICIPATED)

July 30, 2020

Study Completion (ANTICIPATED)

July 30, 2020

Study Registration Dates

First Submitted

October 11, 2019

First Submitted That Met QC Criteria

October 11, 2019

First Posted (ACTUAL)

October 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 17, 2019

Last Update Submitted That Met QC Criteria

October 15, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-05-0624

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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