Autoimmune UveitisNCT04126850
Pilot Project: The Amplicon and Metatranscriptomic Study of Intra and Extra Intestinal Microbiome in Non-infectious Uveitis Disease
An observational study of Autoimmune Uveitis and Behçet Disease, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Uveitis, Behçet Disease, Vogt-Koyanagi-Harada Disease
- How many people
- 10 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Nov 2019to 30 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Non-infectious and idiopathic uveitis patients registered from November 2019 at Cipto Mangunkusumo Hospital, Indonesia.
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
Jakarta Pusat, Jakarta Special Capital Region, 10320
RSCM Kirana, +622131902885, kolit.rscmkirana@gmail.com
Divisi IIM RSCM Kirana, +6285781170297, iim.rscmkirana@gmail.com
About this study
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
Read the 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.
- Conditions
- Autoimmune Uveitis, Behçet Disease, Vogt-Koyanagi-Harada Disease, Idiopathic Uveitis, Noninfectious Panuveitis, Anterior Uveitis Idiopathic
- Keywords
- Microbiome, Autoimmune Uveitis, Vogt-Koyanagi-Harada Disease, Behçet Disease, Idiopathic Uveitis, Metatranscriptomic, Amplicon
- Medical subject headings
- Behcet Syndrome, Uveomeningoencephalitic Syndrome, Uveitis, Posterior, Uveitis, Intermediate
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 6 weeks
Secondary outcomes (1)
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.
Measured: 0, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start1 Nov 2019 (estimated)
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ratna Sitompul, Fakultas Kedokteran Universitas Indonesia
- Investigators
- Ratna Sitompul, Professor, Principal investigator, RSUPN dr. Cipto Mangunkusumo Hospital (RSCM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126850
- Sponsor's protocol ID
- 19-05-0624
- Status last verified
- Oct 2019
- First submitted
- 11 Oct 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04126850
- Acronym / sponsor ID
- 19-05-0624
- Conditions
- Autoimmune Uveitis, Behçet Disease, Vogt-Koyanagi-Harada Disease, Idiopathic Uveitis, Noninfectious Panuveitis, Anterior Uveitis Idiopathic
- Keywords
- Microbiome, Autoimmune Uveitis, Vogt-Koyanagi-Harada Disease, Behçet Disease, Idiopathic Uveitis, Metatranscriptomic, Amplicon
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Non-infectious and idiopathic uveitis patients registered from November 2019 at Cipto Mangunkusumo Hospital, Indonesia.
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Detection pathogenic microorganism in samples
Time frame: 0, 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ratna Sitompul, Professor principal investigator
RSUPN dr. Cipto Mangunkusumo Hospital (RSCM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Uveitis and Behçet Disease, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ratna Sitompul, Professor (+628118009911, ratna_sitompul@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential abundant taxonomic groups bacterial (time frame: 0, 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019.