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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032825
Receipt No. R000037429
Scientific Title The effect of probiotics on depressive symptoms in depressed patients
Date of disclosure of the study information 2018/06/01
Last modified on 2021/06/04

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Basic information
Public title The effect of probiotics on depressive symptoms in depressed patients
Acronym The effect of probiotics on depressive symptoms in depressed patients
Scientific Title The effect of probiotics on depressive symptoms in depressed patients
Scientific Title:Acronym The effect of probiotics on depressive symptoms in depressed patients
Region
Japan

Condition
Condition Depression
Classification by specialty
Medicine in general Neurology Psychosomatic Internal Medicine
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the effect of probiotics on intestinal flora and depressive symptoms in depressed patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Hamilton Depression Rating Scale(HAM-D)
2. Mini-International Neuropsychiatric Interview
3. ROME-III/ IV
4.Distribution of bacterial in feces
Key secondary outcomes 1. Psychometric tests
2. Plasma/Serum hormones
3. Magnetic resonance imaging

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 Prevention
Type of intervention
Food
Interventions/Control_1 Intake probiotics for 3 months.
(L. casei YIT 9029)
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
65 years-old >
Gender Male and Female
Key inclusion criteria (1)Depressed patient (HAM-D score more than 11 point).
(2)Subjects showing a sufficient understanding of the clinical trial procedure and agreeing to participate in the study by written informed consent at his own will.
(3)For Japanese who aged 20 or over and under 65 years old when acquiring
(4)Right-handed person
Key exclusion criteria (1)Subjects who have a history of cardiovascular disease, liver disease, kidney disease, digestive tract disease and diabetes.
(2)Subjects suspected to suffer from alcohol dependence and / or drug dependence.
(3)Subjects who have a specific configuration that occur allergy and / or hypersensitivity against test drinks.
(4)Marked suicidal ideation as indexed by three points or more on the "suicide" item of HAM-D.
(5)Subjects who have edema in the brain.
(6)Subjects who are diagnosed as a complication of dementia or intellectual disability.
(7)Subjects who are lactating and/or pregnant.
(8)Subjects who have a contraindication to MRI, such as claustrophobia, tattoo, implanted electrical device (e.g. cardiac pacemaker).
(9)Those who have suffered serious head trauma or a central nervous system disease.
(10)Subjects who are judged as unfit for the subject by the principal investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Kunugi
Organization National Center of Neurology and Psychiatry
Division name Department of Mental Disorder Research
Zip code 187-8551
Address 4-1-1 Ogawahigashicho, Kodaira-city, Tokyo, Japan
TEL 042-341-2711
Email hkunugi@ncnp.go.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Kunugi
Organization National Center of Neurology and Psychiatry
Division name Department of Mental Disorder Research
Zip code 187-8551
Address 4-1-1 Ogawahigashicho, Kodaira-city, Tokyo, Japan
TEL 042-341-2711
Homepage URL https://www.ncnp.go.jp/nin/guide/r3/psycho-test/guidance.html
Email hkunugi@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Yakult Honsha Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Ethics committee of the National Center of Neurology and Psychiatry
Address 4-1-1 Ogawahigashicho, Kodaira-city, Tokyo, Japan
Tel 042-341-2711
Email rinri-jimu@ncnp.go.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
2018 Year 06 Month 01 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000037429
Publication of results Published

Result
URL related to results and publications https://www.mdpi.com/2076-2607/9/5/1026
Number of participants that the trial has enrolled 22
Results The HAM-D21 score decreased significantly over the intervention period
No statistically significant change for the percentage of subjects diagnosed with IBS.
The counts of total lactobacilli and its subpopulation, Lacticaseibacillus both increased significantly after the intervention. No other bacterial targets were not significantly changed.
Subgroup analyses indicated that greater exposure to Bifidobacterium and the Atopobium cluster was associated with greater reduction of depressive symptoms.
Results date posted
2021 Year 06 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Below are baseline characteristics of 18 participants whose data were analyzed.
sex: 14 females and 4males
diagnosis: 15MDD, 3BD
age: 40.6(11.4) years
Education: 15.0(2.2) years
BMI: 21.80(4.22) kg/m^2
HAM-D21 total score: 17.7(4.1)
BDI score: 31.5(11.0)

Participant flow Initially, a total of 22 participants were enrolled. However, two participants were later excluded due to withdrawal of the informed consent during the study. Of the the 20 participants who completed the study, two who violated the protocol (one used antibotics for Helicobacter pylori eradication, and the other did not submit stool samples) were excluded, leaving 18 participants for the analysis.
Adverse events No adverse events attributable to the intervention were observed during the study period.
Outcome measures 1. The HAM-D21 total score decreased significantly over the intervention period (0 weeks 17.7(4.1), 12 weeks 10.9(7.3); p < 0.001)
2. The percentage of subjects diagnosed with IBS changed from 38.9% at 0 weeks to 16.7% at 12 weeks, but this change was not statistically significant.
3. The counts of total lactobacilli and its subpopulation, Lacticaseibacillus both increased significantly after the intervention (p < 0.001). No other bacterial targets were not significantly changed.

4. We conducted the responder analysis based on the extent of reduction of depressive symptoms. The subjects whose HAM-D21 score became half the baseline or less were designated as responder (n = 8), and the others as non-responder (n = 10). At baseline (0 weeks), the responders showed significantly higher counts of Bifidobacterium (p < 0.05) and the Atopobium (p < 0.05) cluster than non-responders. To evaluate the relationship between bacterial exposure over the time and reduction of depressive symptoms, we calculated the area under the curve over the 12-week study (AUC_0-12) of the gut microbiota. The AUC_0-12 of both Bifidobacterium and the Atopobium cluster had a significantly negative correlation with the HAM-D21 change (ps < 0.05), indicating that greater exposure to these bacterium was associated with greater reduction of depressive symptoms.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 01 Month 05 Day
Date of IRB
2018 Year 01 Month 23 Day
Anticipated trial start date
2018 Year 05 Month 11 Day
Last follow-up date
2019 Year 03 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 01 Day
Last modified on
2021 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037429

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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