UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027164 |
|---|---|
| Receipt number | 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 | 2020/06/01 15:56:10 |
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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 | Obstetrics 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
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
m.fujinami@natural-s.jp
Sponsor or person
Institute
Natural Science Co.,Ltd.
Research and Development Department
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030828
