UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the effect of wood creosote on intestinal flora
Title of the study (Brief title)	A study to evaluate the effect of wood creosote on intestinal flora
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To measure the indirect sterilization effect of wood creosote by quantitative investigation of the changes in intestinal flora after medication of wood creosote in usual dose
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Chronological changes in the copy numbers of extracted DNA per unit mass (gram of feces used in extraction) as the change parameter of the intestinal flora.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Fecal sampling for 3 days before medication ---- take 3 capsules after each meal (total 135 mg wood creosote) (9 capsules per day, grand total 405 mg wood creosote) ---- Fecal sampling for 3 days after medication. Medication period: one day.
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	50 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Japanese male female healthy volunteers above 20 and below 50 years of age when written informed consent is obtained. 2. Subjects who are judged as eligible in the screening test by the principal investigator 3. Subjects who realize the object and contents of the study and submit the written informed consent
Key exclusion criteria	1.Subjects who have a disease under treatment 2.Subjects who have diarrhea with fever, bloody stool or continued mucus stool 3.Pregnant and lactating female, or subjects who are judged as pregnant 4.Subjects who have hypersensitivity or idiosyncrasy to drugs, in particular wood creosote, or those with a history of that 5.Subjects with constipation or diarrhea 6.Subjects who have more drinking habits than the appropriate range and excessive smoking habits 7.Subjects who used or took a medicine within one week before the first day of the study or those who need to use or take a medicine 8.Subjects who take foods for specified health uses , foods with function claims and foods with nutrient function claims (supplements in capsule form and others), excluding those who can stop taking those foods after informed consent) 9.Shift workers during the night 10.Subjects who cannot regularly consume three meals in the morning, noon, and evening, every day 11.Subjects who are planning to travel both domestically and abroad for one week before the first day of the study or during the study period 12.Subjects who cannot participate in the screening test and the study period (7 days), or who cannot visit on the prescribed date 13.Subjects who are unable to fill in their daily diaries during the prescribed period 14.Subjects who donated more than 200 mL of blood within one month before the first day of the study or subjects who have the schedule during the study period 15.Subjects who participated in other clinical trials within 12 weeks before the first day of the study and received medication 16.Subjects who are judged as ineligible to participate in the study for other reasons by the principal investigator
Target sample size	10

Research contact person
Name of lead principal investigator	Takanori Miura
Organization	Taiko Pharmaceutical Co., Ltd.
Division name	Kyoto Plant/R&D Center
Address	1-2-1 Hikaridai, Seikacho, Soraku-gun, Kyoto
TEL	0774-98-2716
Email	miura@seirogan.co.jp

Public contact
Name of contact person	Junko Fujii
Organization	New Drug Research Center Inc.
Division name	Clinical Research Development
Address	2-7-5 Toranomon Minato-ku Tokyo
TEL	03-5510-6908
Homepage URL
Email	j-fujii@ndrcenter.co.jp

Sponsor
Institute	Taiko Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization	Taiko Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	医療法人社団 盟生会 東新宿クリニック

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 06 Day
Anticipated trial start date	2017 Year 04 Month 28 Day
Last follow-up date	2017 Year 06 Month 15 Day
Date of closure to data entry	2017 Year 06 Month 21 Day
Date trial data considered complete	2017 Year 07 Month 12 Day
Date analysis concluded	2017 Year 07 Month 14 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	No decrease of the number of intestinal bacteria was confirmed when regular-dose wood creosote was administered. Based upon this result, it is concluded that intestinal bacteria are not killed by the administration of regular-dose wood creosote.
Other related information

Management information
Registered date	2017 Year 04 Month 10 Day
Last modified on	2017 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030888