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

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 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


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

Value
https://center6.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