UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025417 |
|---|---|
| Receipt number | R000029257 |
| Scientific Title | A study examining the effect of consuming foods containing probiotics on anxiety and depressive symptoms : A non-randomized and open trial |
| Date of disclosure of the study information | 2017/01/04 |
| Last modified on | 2017/07/25 10:49:18 |
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Basic information
Public title
A study examining the effect of consuming foods containing probiotics on anxiety and depressive symptoms : A non-randomized and open trial
Acronym
A study examining the effect of consuming foods containing probiotics on anxiety and depressive symptoms : A non-randomized and open trial
Scientific Title
A study examining the effect of consuming foods containing probiotics on anxiety and depressive symptoms : A non-randomized and open trial
Scientific Title:Acronym
A study examining the effect of consuming foods containing probiotics on anxiety and depressive symptoms : A non-randomized and open trial
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to confirm the hypothesis that consuming food including probiotics increases the Bifidobacterium occupancy rate in guts of subjects and that the increase in the occupancy rate is correlated with improvement of anxiety and depressive symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
The correlation coefficient between increase in the Bifidobacterium occupancy rate and decrease in HADS score for 4 weeks in low Bifidobacterium group
Key secondary outcomes
1. Completion rate for 4 weeks and its 95% confidence interval
2. Adverse effects: incidence rates of adverse events after 4 and 8 weeks and their 95% confidence intervals
3. The correlation coefficient among intestinal microbiota composition, Simpson's reciprocal index, which indicate the diversity of intestinal microbiota composition, Food Frequency Questionnaire(FFQ), Hospital Anxiety and Depression Scale(HADS), Positive and negative symptom scale(PANSS), Profile of Mood States(POMS), Schizophrenia Quality of Life Scale(JSQLS) at baseline
4. The correlation coefficient between increase in the Bifidobacterium occupancy rate and decrease in HADS, PANSS, POMS and JSQLS scores after 4 weeks in all subjects
5. The correlation coefficient between increase in intestinal microbiota composition and decrease in HADS, PANSS, POMS and JSQLS scores after 4 weeks in all subjects
6. Blood samples: the amount of change in metabolites such as nucleic acids, protein, glucose, organic acids and amino acids and multiple cytokines and chemokines after 4 and 8 weeks
7. Body weight and glycolipid metabolism: the changes in body weight, blood glucose level, HbA1c, GOT, GPT, LDH, gamma-GTP, CRP, Total Cholesterol, HDL Cholesterol, and Triglyceride after 4 and 8 weeks
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consuming two sachets of probiotics per day for 4 weeks
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Subjects who are seen at regularly and irregularly scheduled consultation and not admitted to hospital more than 6 months after last discharge
2. Subjects who have anxiety and depressive symptoms that are rated 10 or more points on Brief Psychiatric Rating Scale anxiety and depressive items (1,2,5,9)
3. Subjects who provide written informed consent to participate in the study with sufficient understanding and of their own volition after receiving comprehensive explanation of the study.
Key exclusion criteria
1. Subjects who have uncontrolled diseases or untreatable malignant tumor.
2. Subjects who have cognitive impairment disorder or disturbance of consciousness
3. Subjects who have severe idea of suicide or symptoms that require to urgent treatment
4. Subjects who want to take medications for anxiety or depressive symptoms
5. Subjects who have taken antidepressants in the last month
6. Subjects whose daily intake of food or supplements includes Bifidobacterium
7. Subjects who daily consume a high amount of alcohol (more than 500 ml of beer per day)
8. Subjects who have mental disorders not including schizophrenia, mood disorder, or anxiety disorder
9. Subjects who are deemed to be inappropriate to participate in this study, by the physician in charge of this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Hashimoto |
Organization
Hokkaido University Hospital
Division name
Department of Psychiatry and Neurology
Zip code
Address
West 7, North 15, Kita Ward, Sapporo City, Hokkaido
TEL
011-706-5160
hashimona@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Okubo |
Organization
Hokkaido University Hospital
Division name
Department of Psychiatry and Neurology
Zip code
Address
West 7, North 15, Kita Ward, Sapporo City, Hokkaido
TEL
011-706-5160
Homepage URL
rokubo@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital Department of Psychiatry and Neurology
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
Address
Tel
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 04 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 12 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 20 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 26 | Day |
Last modified on
| 2017 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029257
