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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000027303
Receipt No. R000031285
Scientific Title Research on a lactic acid bacterium preparation for stress relief
Date of disclosure of the study information 2017/07/01
Last modified on 2019/11/11

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Basic information
Public title Research on a lactic acid bacterium preparation for stress relief
Acronym Research on a lactic acid bacterium preparation for stress relief
Scientific Title Research on a lactic acid bacterium preparation for stress relief
Scientific Title:Acronym Research on a lactic acid bacterium preparation for stress relief
Region
Japan

Condition
Condition Healthy adults who feel stress
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verification of the effects of LAB-ingestion on mental and physical conditions under chronic stress
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluate the effects of LAB-ingestion on mental and physical conditions at 12 and 24 weeks after the start of intervention by stress-related questionnaires and several measurement items
Key secondary outcomes Evaluate the effects of LAB-ingestion on sleep quality and abdominal symptoms by questionnaires and related-measurement items

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Daily intake of formulation including LAB for 24 weeks before the National Examination for Medical Practitioners
Interventions/Control_2 Daily intake of placebo formulation without LAB for 24 weeks before the National Examination for Medical Practitioners
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 Subjects are without major problems in psychological and physical health.
Key exclusion criteria 1. Subjects having history of psychiatric or somatic diseases in the past and present.
2. Subjects taking medication at least for three months prior to the enrollment and during the experimental period.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Kazuhito
Middle name
Last name Rokutan
Organization Tokushima University
Division name Dept. of Pathophysiology, Inst. of Biomedical Sciences
Zip code 7708503
Address 3-18-15 Kuramoto-cho, Tokushima
TEL 088-633-9004
Email rokutan@tokushima-u.ac.jp

Public contact
Name of contact person
1st name Kensei
Middle name
Last name Nishida
Organization Tokushima University
Division name Dept. of Pathophysiology, Inst. of Biomedical Sciences
Zip code 7708503
Address 3-18-15 Kuramoto-cho, Tokushima
TEL 088-633-9004
Homepage URL
Email knishida@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

Funding Source
Organization Asahi Group Holdings, 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 Clinical Trial Center For Development Therapeutics
Address 2-50-1 Kuramotocho, Tokushima city
Tel +81-88-633-9294
Email awachiken@tokushima-u.ac.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
2017 Year 07 Month 01 Day

Related information
URL releasing protocol Nutrients 2019, 11(8), 1859; https://doi.org/10.3390/nu11081859
Publication of results Published

Result
URL related to results and publications Nutrients 2019, 11(8), 1859; https://doi.org/10.3390/nu11081859
Number of participants that the trial has enrolled 74
Results
1. CP2305 reduced anxiety and sleep disturbance relative to placebo. 
2. CP2305 shortened sleep latency and wake time after sleep onset and increased the delta power ratio in the first sleep cycle.
3. CP2305 lowered salivary chromogranin A levels compared with placebo. 4. CP2305 administration attenuated the stress-induced decline of Bifidobacterium spp. and the stress-induced elevation of Streptococcus spp.
Results date posted
2019 Year 11 Month 11 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy young adults (average age 24.9 +- 0.5)
Participant flow
The study was designed as a double-blind, placebo-controlled, parallel-group clinical trial and ran from July 2017 to March 2018.
Seventy-four sixth-grade medical students were recruited at Tokushima University, Tokushima, Japan. Written informed consent was obtained from all participants, and they were randomly allocated to either the CP2305 or placebo group with a stratified randomization by gender.
Fourteen of the 74 participants were excluded as they were taking medications, or for hormonal contraceptives and active disease (mental disease, inflammatory disease, bone disease, and hormonal disorder). 
Finally, 29 participants (20 males and nine females) were allocated to the CP2305 group and 31 (21 males and 10 females) to the placebo group. 
The participants were instructed to ingest two tablets (placebo or CP2305) once daily for 24 weeks.
Adverse events
No adverse event was reported.
Outcome measures
1. Questionnaires to Assess Mental and Physical States.
2. Measurements of Salivary Cortisol and Chromogranin A (CGA).
3. Measurement and Assessment of Single-Channel Sleep Electroencephalogram (EEG).
4. Assessment of Stool Properties and Bowel Habits.
5. Measurement of Short-Chain Fatty Acid (SCFA) Concentrations in Feces.
6. Fecal Microbiota Analysis.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2017 Year 06 Month 15 Day
Date of IRB
2017 Year 06 Month 19 Day
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 10 Day
Last modified on
2019 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031285

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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