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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029618
Receipt No. 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

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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
Email 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
Email hiroki054839@gmail.com

Sponsor
Institute Hiroshima University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033833

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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