UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026926 |
|---|---|
| Receipt number | R000030888 |
| Scientific Title | A study to evaluate the effect of wood creosote on intestinal flora |
| Date of disclosure of the study information | 2017/04/28 |
| Last modified on | 2017/08/08 13:27:37 |
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Basic information
Public title
A study to evaluate the effect of wood creosote on intestinal flora
Acronym
A study to evaluate the effect of wood creosote on intestinal flora
Scientific Title
A study to evaluate the effect of wood creosote on intestinal flora
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takanori Miura |
Organization
Taiko Pharmaceutical Co., Ltd.
Division name
Kyoto Plant/R&D Center
Zip code
Address
1-2-1 Hikaridai, Seikacho, Soraku-gun, Kyoto
TEL
0774-98-2716
miura@seirogan.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Fujii |
Organization
New Drug Research Center Inc.
Division name
Clinical Research Development
Zip code
Address
2-7-5 Toranomon Minato-ku Tokyo
TEL
03-5510-6908
Homepage URL
j-fujii@ndrcenter.co.jp
Sponsor or person
Institute
Taiko Pharmaceutical Co., Ltd.
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
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.
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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 06 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030888
