UMIN-CTR Clinical Trial

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 Yuna Middle name Last name Watanabe
Organization	Niigata University of Health and Welfare
Division name	Department of Health and Nutrition
Zip code	950-3198
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 Misa Middle name Last name Fujinami
Organization	Natural Science Co.,Ltd.
Division name	Research and Development Department
Zip code	136-0037
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	Niigata University of Health and Welfare IRB
Address	1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, 950-3198, JAPAN
Tel	025-257-4455
Email	eri-sakata@nuhw.ac.jp

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	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	41
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	Completed
Date of protocol fixation	2017 Year 02 Month 01 Day
Date of IRB	2017 Year 02 Month 10 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date	2020 Year 04 Month 30 Day
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	2020 Year 06 Month 01 Day

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