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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035618
Receipt No. R000040576
Scientific Title Analysis of an association between dry eye and ocular surface and intestinlal microbiome
Date of disclosure of the study information 2019/01/22
Last modified on 2019/07/24

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Basic information
Public title Analysis of an association between dry eye and ocular surface and intestinlal microbiome
Acronym Dry eye and microbiome
Scientific Title Analysis of an association between dry eye and ocular surface and intestinlal microbiome
Scientific Title:Acronym Dry eye and microbiome
Region
Japan

Condition
Condition Chronic graft-versus-host disease (GVHD)-related dry eye disease after hematopoietic stem cell transplantation
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To describe the exploitary analysis on the changes of ocular surface and intestinal microbiome with or without chronic graft-versus-host disease (GVHD)-related dry eye disease after hamatopoietic stem cell transplantation(HSCT).
Basic objectives2 Others
Basic objectives -Others To explore the differences of ocular surface and intestinal microbiome with or without chronic GVHD-related dry eye disease. To explore the relationship between the changes of ocular surface and intestinal microbiome and the severity of chronic GVHD-related dry eye disease.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Characterization of microbiota for chronic GVHD-related dry eye disease compared with the controls.
Key secondary outcomes Functional expectation of ocular surface and intestinal microbiome depending on the severity of chronic GVHD-related dry eye disease.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Adult over 20 years old who is attending dry eye clinic at Keio University Hospital
2) Written informed consent
3) Patients who have newly developed dry eye disease (i.e. chronic GVHD-related dry eye disease) after hematopoietic stem cell transplantation (HSCT).
4) Patients who did not develop dry eye disease after HSCT.
5) Patients who did not have dry eye disease before HSCT.

Eligible for the patients who can be recruited is to fulfill the above number of 1) 2)3)or 1)2)4) or 1)2)5)

Diagnostic criteria for dry eye by Japanese Dry Eye Society 2006
Key exclusion criteria 1) No written informed consent
2) No other autoimmune disease
3) No allergic conjunctivitis, ocular surface infectious disease, nor contact lens wearer
4) No dry eye disease before hematopietic stem cell transplantation

Target sample size 90

Research contact person
Name of lead principal investigator
1st name Shigeto
Middle name
Last name Shimmura
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code 160-8582
Address 35 Shinanomachi Shinjuku-ku, Tokyo, Japan
TEL 0353633972
Email shige@z8.keio.jp

Public contact
Name of contact person
1st name Yoko and Eisuke
Middle name
Last name Ogawa and Shimizu
Organization Keio University Schol of Medicine
Division name Department of Ophthalmology
Zip code 160-8582
Address 35 Shinanomachi Shinjuku-ku Tokyo, 160-8582, Japan
TEL 0353633972
Homepage URL
Email yoko@z7.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization JKiC (JSR and Keio University Medicine and Chemistry Innovation Center) Academic Study Developing Project
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical committee Keio University School of Medicine
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
Tel 03-3353-1211(62014)
Email med-rinri-jimu@adst.keio.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 01 Month 15 Day
Date of IRB
2018 Year 01 Month 15 Day
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2020 Year 03 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1) Shirmer test, Conreal sensitivity, tear clearence, fluorescein staining, Lissamin green staining, tear film break up time, questionnaire for symptom (ocular surface disease index (OSDI))
2) Visual acuity, ocular tension, refraction, length of eye, vitoreoretinal abnormality according to routine examination for eye.
3) Impression cytology and brush cytology for conjunctiva
4) Stool
5) Medical history
6) Researcher will analyse the above mentioned examinations.

Management information
Registered date
2019 Year 01 Month 22 Day
Last modified on
2019 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040576

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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