UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043026 |
|---|---|
| Receipt number | R000049118 |
| Scientific Title | Open study on safety and efficacy of "mulberry leaf green juice" or "baby oligo (kestose)" in pregnant females |
| Date of disclosure of the study information | 2021/01/16 |
| Last modified on | 2021/07/31 16:07:30 |
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Basic information
Public title
A study to test the efficacy of "mulberry leaf green juice" or "baby oligo (kestose)" in improving intestinal environment in pregnant females
Acronym
A study to test the efficacy of prebiotics in improving intestinal environment
Scientific Title
Open study on safety and efficacy of "mulberry leaf green juice" or "baby oligo (kestose)" in pregnant females
Scientific Title:Acronym
Open study on safety and efficacy of prebiotics in pregnant females
Region
| Japan |
Condition
Condition
Pregnant females
Classification by specialty
| Gastroenterology | Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the safety and efficacy in ameliorating intestinal environment of green mulberry leaf juice and kestose administered for 12 weeks in pregnant women 20 to 45 years of age
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Enteric environment (bifidobacterium, Bacteroides, Prevotella, Clostridium, total bacterial count et al.)
Key secondary outcomes
Urinary indoxyl sulfate
Urinary creatinine
Urinary 8-OHdG
Salivary IgA
Questionnaire survey
Safety assessment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingested food : "mulberry leaf green juice"
Dose : Two packets per day Drink
Period : 12 weeks
Interventions/Control_2
Ingested food : "baby oligo (kestose)"
Dose : Two packets per day Drink
Period : 12 weeks
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
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
1)Patients who have received adequate explanation of the purpose and content of this study, are able to give informed consent, voluntarily volunteer after fully understood, and agree to participate in writing.
2)Japanese people aged 20 to <45 years at the time of informed consent
3)Those who between 12 and 25 weeks' gestation at baseline
Key exclusion criteria
1)Patients with chronic disease who are receiving drug treatment or who have a history of disease
2)Individuals with allergies, etc. to the test article
3)Those currently taking foods or green juice containing mulberry leaf regularly
4)Those currently taking prebiotic or probiotic formulation or foods regularly
5)Those currently taking drugs, specified insurance foods, or health foods that may affect bowel movements
6)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.
7)Women judged by the attending physicians and principal investigator as being inappropriate candidates for inclusion in the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshizumi |
| Middle name | |
| Last name | Sato |
Organization
Natural Science Co.,Ltd.
Division name
Research and Development Department
Zip code
136-0073
Address
3-4-27 Kitasuna, Koto-ku, Tokyo 136-0073, JAPAN
TEL
0356652311
y.sato@natural-s.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Ando |
Organization
Natural Science Co.,Ltd.
Division name
Research and Development Department
Zip code
136-0073
Address
3-4-27 Kitasuna, Koto-ku, Tokyo 136-0073, JAPAN
TEL
0356652311
Homepage URL
ando@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
Kanagawa Midwives Association
B Food Science Co., Ltd.
Healthcare Systems Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel
0368092722
soumu@hc-sys.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
ウパウパハウス 岡本助産院、かもめ助産院、とわ助産院、みどり助産院、横須賀マタニティクリニック、めぐみ助産院、森重助産院 (いずれも神奈川県)
UPAUPAHOUSE okamotojosanin、Kamome Maternity Clinic、Towa jyosanin、Midori jyosanin、Yokosuka Maternity Clinic、Megumi jyosanin、Morishige jyosanin (All Kanagawa)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 16 | 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
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 07 | 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
| 2021 | Year | 01 | Month | 16 | Day |
Last modified on
| 2021 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049118
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| Registered date | File name |
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