UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056303 |
|---|---|
| Receipt number | R000063975 |
| Scientific Title | A Single-Arm Pre-Post Comparison Study on the Stress-Reducing Effects of Lactic Acid Bacteria Beverages and Their Impact on the Gut-Brain Axis in Individuals with Autism Spectrum Disorder |
| Date of disclosure of the study information | 2024/11/29 |
| Last modified on | 2024/11/29 09:32:38 |
* 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
A Single-Arm Pre-Post Comparison Study on the Stress-Reducing Effects of Lactic Acid Bacteria Beverages and Their Impact on the Gut-Brain Axis in Individuals with Autism Spectrum Disorder
Acronym
A Single-Arm Pre-Post Comparison Study on the Stress-Reducing Effects of Lactic Acid Bacteria Beverages and Their Impact on the Gut-Brain Axis in Individuals with Autism Spectrum Disorder
Scientific Title
A Single-Arm Pre-Post Comparison Study on the Stress-Reducing Effects of Lactic Acid Bacteria Beverages and Their Impact on the Gut-Brain Axis in Individuals with Autism Spectrum Disorder
Scientific Title:Acronym
A Single-Arm Pre-Post Comparison Study on the Stress-Reducing Effects of Lactic Acid Bacteria Beverages and Their Impact on the Gut-Brain Axis in Individuals with Autism Spectrum Disorder
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Psychosomatic Internal Medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to examine the stress-reducing effects of Lacticaseibacillus casei strain Shirota intake on individuals with Autism Spectrum Disorder.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to determine if it improves sleep quality and behavioral disturbances in individuals with Autism Spectrum Disorder.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cortisol level
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Subjects will consume a beverage containing Lacticaseibacillus casei strain Shirota for 8 weeks. Saliva samples, behavioral assessments, and stool samples will be collected before, immediately after, and 2 weeks after consumption.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(i) Is between 20 and 60 years of age
(ii) Able to consume LcS-containing beverages for 8 weeks continuously
(iii) The person has a letter of referral or a disability certificate confirming the following diagnosis; meets the diagnostic criteria for autism spectrum disorder
(iv) The individual or his/her surrogate understands the content of this study and gives written consent
(v) The family physician agrees to participate in the study
Key exclusion criteria
(i) Those with a referral letter or disability certificate confirming the following diagnoses; schizophrenia and other psychotic disorders, delirium, dementia, amnesia, and other cognitive disorders, substance-related disorders, eating disorders, and personality disorders that meet one of the diagnostic criteria.
(ii) Those who require strict dietary control
(iii) Those who suffer from other chronic underlying diseases
(iv) Women of childbearing potential, pregnant, or lactating women
(v) Those who usually consume Yakult1000, other lactic acid bacteria beverages, probiotics, etc.
(vi) Other subjects who are judged to be inappropriate as research subjects by the Principal Investigator or Research Supervisor.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Chiaki |
| Middle name | |
| Last name | Shimizu |
Organization
Hiroshima University
Division name
Special Care Dentistry
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
TEL
082-257-5788
chiakiii@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Chiaki |
| Middle name | |
| Last name | Shimizu |
Organization
Hiroshima University
Division name
Special Care Dentistry
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
TEL
082-257-5788
Homepage URL
chiakiii@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-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
| 2024 | Year | 11 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2029 | 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
| 2024 | Year | 11 | Month | 29 | Day |
Last modified on
| 2024 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063975
