UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029618 |
|---|---|
| Receipt number | R000033833 |
| Scientific Title | The effect of Sericin of intestinal microbiome the in healthy volunteers: a pilot study |
| Date of disclosure of the study information | 2017/10/24 |
| Last modified on | 2018/08/18 20:49:26 |
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Basic information
Public title
The effect of Sericin of intestinal microbiome the in healthy volunteers: a pilot study
Acronym
The effect of Sericin of intestinal microbiome
Scientific Title
The effect of Sericin of intestinal microbiome the in healthy volunteers: a pilot study
Scientific Title:Acronym
The effect of Sericin of intestinal microbiome
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated the effect of Sericin supplements on the intestinal microbiome in healthy volunteers
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the change of intestinal microbiome before or after 1 week taking sericin
Key secondary outcomes
metabolomic analysis, Bristol stool scale, stool frequency, flatus frequency
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
| Food |
Interventions/Control_1
Take Sericin supplements 0.5g per day for 7 days
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Last 1 year medical checkups pointed out no abnormality
Key exclusion criteria
1. Antibiotic treatment within 1 month
2. Any bowel disease that affects bowel movement such as irritable bowel syndrome and ulcerative colitis
3. Any history of gastrointestinal surgery except appendectomy
4. Bloody bowel discharge
5. Usual use of any laxative
6. Use of any viable bacterial preparations
7. Taking other supplements
8. Sericin allegery
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Kitagawa |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Department of infection diseases
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-1613
ohge@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Kitagawa |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Department of Surgery, Applied Life Sciences Institute of Biomedical & Health Sciences
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5215
Homepage URL
hiroki054839@gmail.com
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
the Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 24 | 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
| 2017 | Year | 10 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 18 | Day |
Last modified on
| 2018 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033833
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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