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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027164
Receipt No. R000030828
Scientific Title Study of pregnant women on the interaction among intestinal bacterial flora, physical conditions and nutrition including dietary habits
Date of disclosure of the study information 2017/05/01
Last modified on 2018/10/29

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Basic information
Public title Study of pregnant women on the interaction among intestinal bacterial flora, physical conditions and nutrition including dietary habits
Acronym Study on pregnant women's intestinal bacterial flora
Scientific Title Study of pregnant women on the interaction among intestinal bacterial flora, physical conditions and nutrition including dietary habits
Scientific Title:Acronym Study on pregnant women's intestinal bacterial flora
Region
Japan

Condition
Condition Healthy pregnant women
Classification by specialty
Gastroenterology Obsterics and gynecology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the relationship among intestinal bacterial flora, physical condition, and nutrition and dietary habits, and to verify the effectiveness and safety of "mulberry leaf green juice ingestion" on intestinal bacterial flora and physical condition of pregnant women from early pregnancy to postpartum.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Intestinal bacterial flora
Key secondary outcomes Blood tests
Urinalysis
Blood pressure measurement
Daily defecation status (Frequency, amount of defecation, Bristol stool form scale, stool color, stool smell, feeling after defecation)
Dietary survey (The brief-type self-administered diet history questionnaire)
Questionnaire survey
Safety assessment
Skin tests for resident bacteria(vagina)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Ingested food : Mulberry leaf green juice A
Dose:Three packages per day
Usage:Dissolve in 100 to 180 ml of water or hot water per package and ingest in three divided doses
Period:From early pregnancy to 1 month after childbirth
Interventions/Control_2 Ingested food : Mulberry leaf green juice B
Dose:Three packages per day
Usage:Dissolve in 100 to 180 ml of water or hot water per package and ingest in three divided doses
Period:From early pregnancy to 1 month after childbirth
Interventions/Control_3 Green juice non-intake group
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
45 years-old >
Gender Female
Key inclusion criteria 1) Pregnant women aged 18 to < 45 years.
2) Those who express their willingness to participate in the study and provide consent for participation after understanding the purpose and details of the study.
3) Those who can continue to undergo antenatal checkups at the study site.
Key exclusion criteria 1) Those currently attending the hospital for the treatment of other diseases.
2) Those with diseases that might affect the results of assessment in this study.
3) Those currently taking foods or green juice containing mulberry leaf regularly.
4) Those currently participating in another clinical trial or have participated in another clinical trial within 3 months prior to the start of the present study.
5) Other women judged by the attending physicians as being inappropriate candidates for inclusion in the study.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuna Watanabe
Organization Niigata University of Health and Welfare
Division name Department of Health and Nutrition
Zip code
Address 1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, 950-3198, JAPAN
TEL 025-257-4494
Email yuna-watanabe@nuhw.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Misa Fujinami
Organization Natural Science Co.,Ltd.
Division name Research and Development Department
Zip code
Address 3F NATURAL FACTORY TOKYO, 3-4-27 Kitasuna, Koto-ku, Tokyo 136-0073, JAPAN
TEL 03-5665-2311
Homepage URL
Email m.fujinami@natural-s.jp

Sponsor
Institute Natural Science Co.,Ltd.
Research and Development Department
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Healthcare Systems Co., Ltd.
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 よしかた産婦人科 (神奈川県)
Yoshikata Obsterics and Gynecology Clinic (Kanagawa)

Other administrative information
Date of disclosure of the study information
2017 Year 05 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 Enrolling by invitation
Date of protocol fixation
2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 01 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 04 Month 27 Day
Last modified on
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030828

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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