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

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 - 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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000056303

Enrollment

Registered

2024-11-29

Start date

2024-11-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Interventions

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,

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
cortisol level	—

Countries

Japan

Contacts

Public ContactChiaki Shimizu

Hiroshima University Special Care Dentistry

chiakiii@hiroshima-u.ac.jp082-257-5788

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026