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

NCT07064538 | Enrolling By Invitation

• 1 other identifier: 25CT027be
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ASD; Autism; Autistic Disorders Spectrum

Keywords

Autistic traits; ASD

Outcome Measures

Primary Outcomes (1)

• Goal Attainment Scaling (GAS)

  GAS is a method that can be used as a means of measuring outcome data from different contexts set out on a 5-point scale of -2 to +2. It enables the data to be placed on a quantitative measurement scale thus tackling the problem of how to adequately identify and measure qualitative goal impact and attainment. This is very useful as it enables a linking of measures from the frontline to upper levels of an organization's management. This assessment will be conducted weekly to determine how early the effects of the intervention can be observed.

  weekly from baseline to week 8

Secondary Outcomes (3)

• The Autism Behavior Checklist-Taiwan (ABCT)

  from baseline to week 4 and week 8

• Parent Target Symptom Rating Visual Analogue Scale (PTSVAS)

  from baseline to week 4 and week 8

• Quality of Life in Autism Questionnaire (QoLA)

  from baseline to week 4 and week 8

Study Arms (1)

Neuralli® MP

EXPERIMENTAL

Dietary Supplement: Neuralli® MP

Interventions

Neuralli® MP DIETARY_SUPPLEMENT

Neuralli® MP containing 60 billion CFU (administered as two capsules per day)

Neuralli® MP

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead
• Bened Biomedical Co., Ltd.: collaborator

Study Sites (1)

Mackay Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Autistic Disorder; Child Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 14, 2025
• Study Start: August 19, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

TW (1)