UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055194 |
|---|---|
| Receipt number | R000062819 |
| Scientific Title | Randomized, double-blind, placebo-controlled parallel-group comparative study to investigate the efficacy of synbiotics on mental health in postpartum women |
| Date of disclosure of the study information | 2024/08/09 |
| Last modified on | 2025/02/07 08:41:47 |
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Basic information
Public title
Randomized, double-blind, placebo-controlled parallel-group comparative study to investigate the efficacy of synbiotics on mental health in postpartum women
Acronym
Effects of ingestion of synbiotics on postpartum mental health
Scientific Title
Randomized, double-blind, placebo-controlled parallel-group comparative study to investigate the efficacy of synbiotics on mental health in postpartum women
Scientific Title:Acronym
Effects of ingestion of synbiotics on postpartum mental health
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of synbiotics on mental health.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Edinburgh Postnatal Depression Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test foods for 8 weeks
Interventions/Control_2
Ingestion of placebo foods for 8 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Adult women who underwent a postpartum check-up after two weeks.
2. Subjects who is able to continuously intake test foods during 8 weeks.
Key exclusion criteria
1. Subjects with a score of 9 or higher on the Edinburgh Postnatal Depression Scale, or those who scored 1 or higher on question 10.
2. Subjects with a recent history of their newborn being admitted to the Neonatal Intensive Care Unit (NICU), as well as those who have been admitted in the past.
3. Subjects who are unable to discontinue the intake of medications or over-the-counter drugs that are believed to have an impact on mental health during the trial period.
4. Subjects who are unable to discontinue the intake of oligosaccharides, probiotics (such as lactobacillus and bifidobacterium), or other similar supplements during the trial period.
5. Subjects who have participated in clinical trials of other drugs or foods within the past 6 months.
6. Subjects with a history of drug allergies or severe food allergies.
7. Subjects who are judged inappropriate to this trial by the principal investigator or co-investigator based on the subject's background, physical examination, and results of laboratory and clinical tests.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Fumiaki |
| Middle name | |
| Last name | Kitamura |
Organization
Marunouchi Hospital
Division name
obstetrics & gynecology
Zip code
390-8601
Address
1-7-45 Nagisa, Matsumoto, Nagano
TEL
0263-28-3003
drbunmei@marunouchi.or.jp
Public contact
Name of contact person
| 1st name | Shioji |
| Middle name | |
| Last name | Ota |
Organization
Marunouchi Hospital
Division name
pharmacy department
Zip code
390-8601
Address
1-7-45 Nagisa, Matsumoto, Nagano
TEL
0263-28-3003
Homepage URL
oota_s@marunouchi.or.jp
Sponsor or person
Institute
Marunouchi Hospital
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Marunouchi Hospital
Address
1-7-45 Nagisa, Matsumoto, Nagano
Tel
0263-28-3003
oota_s@marunouchi.or.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 09 | 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
| 2024 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 08 | Day |
Last modified on
| 2025 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062819
