UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032825 |
|---|---|
| Receipt number | 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 15:10:17 |
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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
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
hkunugi@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037429
