Effects of Neuralli® MP on Self-Defined Outcomes in Adults With Autistic Traits

Mackay Memorial Hospital

Status

Invitation-only

Conditions

Autistic Disorders Spectrum

ASD

Autism

Treatments

Dietary Supplement: Neuralli® MP

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07064538

25CT027be

Details and patient eligibility

About

To evaluate the efficacy of Neuralli® MP in improving participant-defined outcomes in adults with autistic traits.

Full description

Autism spectrum disorder (ASD) is a common neurodevelopmental disorder characterized by pervasive difficulties since early childhood across reciprocal social communication and restricted, repetitive interests and behaviors. Although early ASD research focused primarily on children, there is increasing recognition that ASD is a lifelong neurodevelopmental disorder. However, although health and education services for children with ASD are relatively well established, service provision for adults with ASD is in its infancy. There is a lack of health services research for adults with ASD, including identification of comorbid health difficulties, rigorous treatment trials (pharmacological and psychological), development of new pharmacotherapies, investigation of transition and aging across the lifespan, and consideration of sex differences and the views of people with ASD. The health services research for adults with ASD is urgently warranted. In particular, research is required to better understand the needs of adults with ASD, including health, aging, service development, transition, treatment options across the lifespan, sex, and the views of people with ASD.

Lactiplantibacillus plantarum PS128 (PS128), showed ameliorative effects on depression- and anxiety-like behaviors in different mouse models. When administered to children with ASD, PS128 was shown to improve anxiety, rule-breaking behaviors, hyperactivity/impulsivity, social function, inflammation index, and autonomic function. PS128 supplementation has also been shown to improve depressive symptoms and sleep quality for adults with self-reported insomnia, as well as cortisol levels and anxiety. However, even for this well-studied probiotic, its specific effects on broader aspects of ASD, such as core symptoms, cognition, attention, and sleep have not been systematically investigated.

Therefore, this study is designed not only to examine the effects of Neuralli® MP (PS128) but, more importantly, to explore the wider health and support needs of adults with autistic traits. By doing so, this study aims to assess how PS128 may contribute to improving their overall quality of life and address a range of symptoms.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants aged between 18 and 50 who exhibit autistic traits
Those who have the willingness and ability to work but have not yet been able to enter a sheltered workshop at the Kanner Foundation
The subjects, primary caregivers and institution staff are willing to participate in the study, and the primary caregivers and institution staff are willing to fill out the questionnaire and accept the interview

Exclusion criteria

Those who have taken antibiotics or probiotic products in powder, capsule or tablet form within the past month are excluded.
Participants currently receiving antibiotic treatment are also excluded.
Individuals with a known allergy to dairy products.
Individuals with immunodeficiency or compromised immune function.
Individuals diagnosed with small intestinal bacterial overgrowth (SIBO)
Ineligibility determined by PI, e.g. the individual starts any new medication or therapy, especially related to their autism, during this time.