UMIN-CTR Clinical Trial

Basic information
Public title	Usefulness of evaluation of intestinal flora as a predictor of treatment efficacy and prognosis of primary aldosteronism
Acronym	Evaluation of intestinal flora as a predictor of treatment efficacy and prognosis of primary aldosteronism
Scientific Title	Usefulness of evaluation of intestinal flora as a predictor of treatment efficacy and prognosis of primary aldosteronism
Scientific Title:Acronym	Evaluation of intestinal flora as a predictor of treatment efficacy and prognosis of primary aldosteronism
Region	Japan

Condition
Condition	primary aldosteronism
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Primary aldosteronism is one of the typical secondary hypertension. It can be treated with surgery and medication, but the efficacy and progress of treatment are not fully elucidated. We aim to determine the usefulness of evaluation of intestinal flora as predicting treatment efficacy and prognosis for primary aldosteronism.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	diversity of intestinal flora
Key secondary outcomes	serum short chain fatty acid fecal short chain fatty acid

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Among PA patients in our outpatient of department of endocrinology, metabolism and nephrology in Keio Univercity Hospital, we target patients who undergo adrenal vein sampling test and agree with the study.
Key exclusion criteria	cases of post-gastrointestinal surgery cases with gastrointestinal diseases such as inflammatory bowel disease cases of long-term steroid use
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Isao Middle name Last name Kurihara
Organization	Keio university school of medicine
Division name	Endocrinology, metabolism and nephrology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3796
Email	i-kuri@dc4.so-net.ne.jp

Public contact
Name of contact person	1st name Isao Middle name Last name Kurihara
Organization	Keio university school of medicine
Division name	Endocrinology, metabolism and nephrology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3796
Homepage URL
Email	i-kuri@dc4.so-net.ne.jp

Sponsor
Institute	Keio university school of medicine
Institute
Department

Funding Source
Organization	Keio university school of medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Keio University School of Medicine Ethics Commitee
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
Tel	03-5363-3503
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	慶應義塾大学医学部

Other administrative information
Date of disclosure of the study information	2020 Year 06 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	Open public recruiting
Date of protocol fixation	2020 Year 04 Month 13 Day
Date of IRB	2020 Year 05 Month 28 Day
Anticipated trial start date	2020 Year 07 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry	2023 Year 03 Month 31 Day
Date trial data considered complete	2023 Year 03 Month 31 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Other
Other related information	nothing particular

Management information
Registered date	2020 Year 06 Month 22 Day
Last modified on	2020 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046371