UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048184 |
|---|---|
| Receipt number | R000054912 |
| Scientific Title | Examination of the effect of heat-killed lactic acid bacteria on gastrointestinal under psychological stress |
| Date of disclosure of the study information | 2022/06/28 |
| Last modified on | 2026/03/12 13:48:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination of the effect of heat-killed lactic acid bacteria on gastrointestinal under psychological stress
Acronym
Examination of the effect of heat-killed lactic acid bacteria on gastrointestinal under psychological stress
Scientific Title
Examination of the effect of heat-killed lactic acid bacteria on gastrointestinal under psychological stress
Scientific Title:Acronym
Examination of the effect of heat-killed lactic acid bacteria on gastrointestinal under psychological stress
Region
| Japan |
Condition
Condition
Suffering from stomach problems when nervous
Classification by specialty
| Gastroenterology | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the stress-relieving effect of a Heat-killed EC-12 strain on people suffering from stomach problems when nervous
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in salivary cortisol, fecal microbiota, and subjective symptoms after 1 week
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
intake of test for 1 week
Interventions/Control_2
intake of placebo for 1 week
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Adult age of 18 years or more
2) Subjects with subjective symptoms of stomach upset when nervous
3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Key exclusion criteria
Subjects receiving a medical treatment for IBD
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Nagaoka |
Organization
Tokyo University of Agriculture and Technology
Division name
Faculty of Agriculture
Zip code
183-8509
Address
3-5-8 Saiwai-cho, Fuchu-shi, Tokyo
TEL
0423675767
nagaokak@cc.tuat.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Nagaoka |
Organization
Tokyo University of Agriculture and Technology
Division name
Faculty of Agriculture
Zip code
183-8509
Address
3-5-8 Saiwai-cho, Fuchu-shi, Tokyo
TEL
0423675767
Homepage URL
nagaokak@cc.tuat.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture and Technology
Institute
Department
Personal name
Funding Source
Organization
Combi Corporation
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
Tokyo University of Agriculture and Technology Medical Research Ethics Review Committee for Humans
Address
3-8-1 Harumi-cho, Fuchu-shi, Tokyo
Tel
0423675638
kenrinri@m2.tuat.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
| 2022 | Year | 06 | Month | 28 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/39481416/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/39481416/
Number of participants that the trial has enrolled
27
Results
One-week supplementation with heat-killed Enterococcus faecalis EC-12 significantly improved abdominal pain and stomach rumbling in students under academic stress compared with placebo. No significant differences were observed in diarrhea, mental symptoms, or salivary cortisol. Overall gut microbiota composition remained stable, although the relative abundance of E. faecalis and fecal tryptamine levels increased in the EC-12 group.
Results date posted
| 2026 | Year | 03 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 27 healthy university students aged 20-24 years were enrolled in this randomized, double-blind, placebo-controlled study. Participants had no history of gastrointestinal disease, psychiatric disorders, or medication use within three months prior to enrollment.
Participants were randomly assigned to either the EC-12 supplementation group (n=14) or the placebo group (n=13), with stratification by sex. All participants were undergraduate or graduate students experiencing academic examination stress during the study period.
Participant flow
A total of 27 eligible participants were enrolled and randomized in this study. Fourteen participants were assigned to the EC-12 supplementation group and 13 participants to the placebo group.
All participants completed the one-week intervention and follow-up assessments. No participants withdrew from the study and no participants were excluded from the final analysis. Therefore, data from all 27 participants were included in the final analysis.
Adverse events
No adverse events related to the intake of heat-killed Enterococcus faecalis strain EC-12 were reported during the study period. All participants completed the intervention without any safety concerns or clinically significant side effects.
Outcome measures
Primary outcomes
Changes in gastrointestinal symptoms, including abdominal pain, stomach rumbling, and diarrhea, assessed using a visual analogue scale (VAS).
Secondary outcomes
Changes in mental symptoms (stress, nervousness, and anxiety) assessed by VAS; salivary cortisol levels; gut microbiota composition assessed by 16S rRNA gene sequencing; fecal metabolomic profiles and short-chain fatty acid concentrations measured by GC-MS.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 06 | Month | 28 | Day |
Last modified on
| 2026 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054912
