UMIN-CTR Clinical Trial

Basic information
Public title	A long-term observational studies assessing the effects of Buddhist training on the mental and intestinal flora
Acronym	A long-term observational studies assessing the effects of Buddhist training on the mental and intestinal flora
Scientific Title	A long-term observational studies assessing the effects of Buddhist training on the mental and intestinal flora
Scientific Title:Acronym	A long-term observational studies assessing the effects of Buddhist training on the mental and intestinal flora
Region	Japan

Condition
Condition	Healthy person
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the effects of Buddhist training on the mental and intestinal flora of Buddhist practitioners.
Basic objectives2	Others
Basic objectives -Others	Clarify the correlation between the intestinal flora and mentally related indicators
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	intestinal flora
Key secondary outcomes	Anxiety and happiness questionnaire Facial expression related indicators

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	18 years-old <=
Age-upper limit	65 years-old >=
Gender	Male
Key inclusion criteria	1. Buddhist training participants 2. Healthy male
Key exclusion criteria	1. Minors 2.Cannot complete Buddhist training 3.Those suffering from serious illness
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hidetoshi Middle name Last name Miyazaki
Organization	Asahi quarity and innovations, Ltd
Division name	Core technology laboratories
Zip code	302-0106
Address	1-21, Hidori 1-Chome, Moriya-shi, Ibaraki
TEL	08077891278
Email	hidetoshi.miyazaki@asahi-qi.co.jp

Public contact
Name of contact person	1st name Hidetoshi Middle name Last name Miyazaki
Organization	Asahi quality and innovations, Ltd
Division name	Core technology laboratories
Zip code	302-0106
Address	1-21, Hidori 1-Chome, Moriya-shi, Ibaraki
TEL	08077891278
Homepage URL
Email	hidetoshi.miyazaki@asahi-qi.co.jp

Sponsor
Institute	Asahi quality and innovations, Ltd Core technology laboratories
Institute
Department

Funding Source
Organization	None
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	Suda Clinic institutional review board
Address	2-8-14, Takadanobaba, Shinjyuku-ku, Tokyo
Tel	03-6704-5968
Email	n-yuzawa@imeqrd.co.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	2023 Year 04 Month 01 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	Preinitiation
Date of protocol fixation	2022 Year 03 Month 01 Day
Date of IRB	2022 Year 03 Month 30 Day
Anticipated trial start date	2022 Year 04 Month 12 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry	2023 Year 06 Month 30 Day
Date trial data considered complete	2023 Year 06 Month 30 Day
Date analysis concluded	2023 Year 12 Month 31 Day

Other
Other related information	To clarify the effects of Buddhist training on the mental and intestinal flora

Management information
Registered date	2022 Year 04 Month 10 Day
Last modified on	2022 Year 04 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054112