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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025417
Receipt No. 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

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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
Email 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
Email rokubo@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital Department of Psychiatry and Neurology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029257

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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