Open-label Pilot Study Synbiotic Treatment for Autism Spectrum Disorder

NCT06126185 | Completed

• 1 other identifier: 2023.484
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to conduct a open-label pilot study evaluating the feasibility, tolerability and preliminary efficacy of a 12-week course of synbiotic in improving anxiety symptoms in children with ASD. The investigators hypothesise that the course of synbiotic will feasible and tolerable, and that there will be a reduction in anxiety symptoms in ASD children after the 12-week course of synbiotic.

Conditions

Autism Spectrum Disorder; Anxiety

Keywords

synbiotic; probiotic; prebiotic

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events and side effect

  Side effect, adverse events related to the 12-week course of synbiotic treatment

  At week 6 and week 12 of the 12-week course of synbiotic

Secondary Outcomes (5)

• Anxiety symptoms

  At week 6 and week 12 of the 12-week course of synbiotic

• Sensory hyperresponsiveness

  At week 6 and week 12 of the 12-week course of synbiotic

• Gastrointestinal symptoms

  At week 6 and week 12 of the 12-week course of synbiotic

• Intestinal microbiota profile

  At week 6 and week 12 of the 12-week course of synbiotic

• Intestinal metabolites profile

  At week 6 and week 12 of the 12-week course of synbiotic

Study Arms (1)

Synbiotic treatment

EXPERIMENTAL

12-week course of synbiotic

Dietary Supplement: 12-week course of synbiotic

Interventions

12-week course of synbiotic DIETARY_SUPPLEMENT

A 12-week-course of synbiotic, which contains containing 5 billion colony-forming unit (CFU) of a combination of 4 probiotic species belonging to the genus of Lactobacillus, Bifidobacterium and Streptococcus, and 3 prebiotics, will be given to participants to take daily through oral route.

Synbiotic treatment

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASD children of Chinese ethnicity aged \<12 with diagnosis made by child psychiatrists based on Diagnostic and Statistical Manual, Fifth Edition (DSM-5) diagnostic criteria.
• Elevated anxiety level, as measured by Anxiety Scale for Children-Autism Spectrum Disorder (ASC-ASD)
• Presence of sensory hyperresponsiveness, as measured by Sensory Experience Questionnaire (SEQ)

You may not qualify if:

• Co-occurring mental retardation, neurological, psychosis, depression or other severe mental illness.
• History of non-functional gastrointestinal disorders such as inflammatory bowel disease and Hirschsprung's disease.
• Presence of other significant physical illness, including but not limited to: current active malignancy, immunosuppression, organ failure and epilepsy
• Exposure to antibiotics within 1 months of the study or history of using probiotics.
• On special diet such as being a vegetarian

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Wing Ho Wong, MBChB

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Clinical)

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: December 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: July 31, 2025
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)