UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study examining the effect of consuming foods containing probiotics on anxiety and depressive symptoms : A non-randomized and open trial
Title of the study (Brief title)	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	Naoki Hashimoto
Organization	Hokkaido University Hospital
Division name	Department of Psychiatry and Neurology
Address	West 7, North 15, Kita Ward, Sapporo City, Hokkaido
TEL	011-706-5160
Email	hashimona@gmail.com

Public contact
Name of contact person	Ryo Okubo
Organization	Hokkaido University Hospital
Division name	Department of Psychiatry and Neurology
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 12 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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