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

NCT04126850 | Unknown

• 1 other identifier: 19-05-0624
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Detection pathogenic microorganism in samples

  0, 6 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Fakultas Kedokteran Universitas Indonesia: lead

Study Sites (1)

RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)

Jakarta Pusat, Jakarta Special Capital Region, 10320, Indonesia

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Feces * Blood * Aqueous humor

MeSH Terms

Conditions

Behcet Syndrome; Uveomeningoencephalitic Syndrome; Uveitis, Posterior; Uveitis, Intermediate

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ratna Sitompul, Professor

  RSUPN dr. Cipto Mangunkusumo Hospital (RSCM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ratna Sitompul, Professor

CONTACT

+628118009911; ratna_sitompul@yahoo.com

Rina La Distia Nora, PhD

CONTACT

+62811198910; rina.ladistia@ui.ac.id

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. dr. Ratna Sitompul, SpM(K)

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 15, 2019
• Study Start: November 1, 2019
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: October 17, 2019

Record last verified: 2019-10

Locations

ID (1)