Autism Spectrum DisorderNCT06126185
Open-label Pilot Study Synbiotic Treatment for Autism Spectrum Disorder
A study testing 12-week course of synbiotic in people with Autism Spectrum Disorder and Anxiety, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Anxiety
- What is being tested?
- 12-week course of synbiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Synbiotic Treatment for Neuropsychiatric Symptom of Autism Spectrum Disorder: an Open-label Pilot Study
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.
Read the detailed description
Autism spectrum disorder (ASD) is a neurodevelopmental disorder defined by the core features of social communication deficits and restricted and repetitive behaviour (RRB). One important treatment target of ASD children is co-occurring neuropsychiatric disorders, which would interact with the core symptoms to further jeopardize their social and educational development. In pre-pubertal children, anxiety disorder is one of the commonest co-occurring psychiatric disorders without effective therapeutics. Anxiety symptoms is related to sensory hyperresponsiveness, and emerging evidence has shown that sensory atypicality in ASD could be contributed by the altered gut microbiota. Thus, intervention that targets the gut microbiota may improve the clinical anxiety symptoms in ASD children.
In this study, a pilot open-label trial will be conducted. It is planned that 30 ASD children who are below 12 years of age will be recruited from a regional children psychiatric specialist clinic to undergo a 12-week course of synbiotic. Feasibility, tolerability and preliminary efficacy of the synbiotic will be investigated using standardised parent-filled questionnaires. Changes in fecal microbiome and metabolites will be observed. The outcomes will be measured at weeks 6 and 12 of the 12-week course of synbiotic.
The results of the proposed study will provide insights with regards to the design and implementation of the main randomised controlled trial (RCT), contributing to the generation of evidence to the real-life efficacy the synbiotic. Physiological measurements of gut metagenomics and metabolomics will shed light on the specific mechanisms underlying clinical efficacies, which could inform the development of novel therapeutics targeting the microbiota-gut-brain axis in ASD.
- Conditions
- Autism Spectrum Disorder, Anxiety
- Being tested
- 12-week course of synbiotic
- Keywords
- synbiotic, probiotic, prebiotic
- Medical subject headings
- Autism Spectrum Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week course of synbioticDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic treatment | Experimental | 12-week course of synbiotic Receives: Dietary Supplement: 12-week course of synbiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and side effect
Side effect, adverse events related to the 12-week course of synbiotic treatment
Measured: At week 6 and week 12 of the 12-week course of synbiotic
Secondary outcomes (5)
Anxiety symptoms
Change in anxiety symptoms during the12-week course of synbiotic treatment, as measured by the Anxiety Scale for Children-Autism Spectrum Disorder (ASC-ASD)
Measured: At week 6 and week 12 of the 12-week course of synbiotic
Sensory hyperresponsiveness
Change in sensory hyperresponsiveness during the12-week course of synbiotic treatment, as measured by the Sensory Experience Questionnaire (SEQ)
Measured: At week 6 and week 12 of the 12-week course of synbiotic
Gastrointestinal symptoms
Change in gastrointestinal symptoms during the12-week course of synbiotic treatment, as measured by the questionnaire on Paediatric Gastrointestinal Symptoms - Rome IV (QPGS-RIV).
Measured: At week 6 and week 12 of the 12-week course of synbiotic
Intestinal microbiota profile
Stool samples will be collected for shotgun metagenomics sequencing to characterize the gut microbiota changes during the 12-week course of synbiotic treatment. Sequencing libraries will be prepared from extracted DNA and sequenced on an Illumina NovaSeq 6000 System. An average of 26 ± 3.3 million reads (6G data) per sample will be obtained 32 ± 4.6 million reads. Profiling of bacterial taxonomy and functional composition will be done with bioinformatic analysis Alpha-diversity indices, relative abundance of bacterial species will be quantified and compare across different timepoints of the study.
Measured: At week 6 and week 12 of the 12-week course of synbiotic
Intestinal metabolites profile
Stool samples will be collected for metabolomics studies to characterize the gut metabolites changes during the 12-week course of synbiotic treatment. . In brief, the stool sample extracts were then separated using the Ultra Performance Liquid Chromatography. Skyline (MacLean et al., 2010) was used for metabolite identification and quantification. Following data normalization by probabilistic quotient normalization, principal component analysis on quality control samples that were analysed. Quantity of short-chained fatty acids, and other relevant metabolites will then be quantified and compare across different timepoints of the study
Measured: At week 6 and week 12 of the 12-week course of synbiotic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Dec 2023
- Primary completion31 Dec 2024
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wong Wing Ho, Chinese University of Hong Kong
- Investigators
- Wing Ho Wong, MBChB, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126185
- Sponsor's protocol ID
- 2023.484
- Status last verified
- Mar 2026
- First submitted
- 6 Nov 2023
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synbiotic Treatment for Neuropsychiatric Symptom of Autism Spectrum Disorder: an Open-label Pilot Study
- ClinicalTrials.gov ID
- NCT06126185
- Acronym / sponsor ID
- 2023.484
- Conditions
- Autism Spectrum Disorder, Anxiety
- Keywords
- synbiotic, probiotic, prebiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Autism spectrum disorder (ASD) is a neurodevelopmental disorder defined by the core features of social communication deficits and restricted and repetitive behaviour (RRB). One important treatment target of ASD children is co-occurring neuropsychiatric disorders, which would interact with the core symptoms to further jeopardize their social and educational development. In pre-pubertal children, anxiety disorder is one of the commonest co-occurring psychiatric disorders without effective therapeutics. Anxiety symptoms is related to sensory hyperresponsiveness, and emerging evidence has shown that sensory atypicality in ASD could be contributed by the altered gut microbiota. Thus, intervention that targets the gut microbiota may improve the clinical anxiety symptoms in ASD children.
In this study, a pilot open-label trial will be conducted. It is planned that 30 ASD children who are below 12 years of age will be recruited from a regional children psychiatric specialist clinic to undergo a 12-week course of synbiotic. Feasibility, tolerability and preliminary efficacy of the synbiotic will be investigated using standardised parent-filled questionnaires. Changes in fecal microbiome and metabolites will be observed. The outcomes will be measured at weeks 6 and 12 of the 12-week course of synbiotic.
The results of the proposed study will provide insights with regards to the design and implementation of the main randomised controlled trial (RCT), contributing to the generation of evidence to the real-life efficacy the synbiotic. Physiological measurements of gut metagenomics and metabolomics will shed light on the specific mechanisms underlying clinical efficacies, which could inform the development of novel therapeutics targeting the microbiota-gut-brain axis in ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Synbiotic treatment | Experimental | Dietary Supplement: 12-week course of synbiotic12-week course of synbiotic |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-week course of synbioticA 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. | Dietary supplement | Synbiotic treatment |
Primary outcome
Incidence of adverse events and side effect
Time frame: At week 6 and week 12 of the 12-week course of synbiotic
Side effect, adverse events related to the 12-week course of synbiotic treatment
5 secondary outcomes
Anxiety symptoms
Time frame: At week 6 and week 12 of the 12-week course of synbiotic
Sensory hyperresponsiveness
Time frame: At week 6 and week 12 of the 12-week course of synbiotic
Gastrointestinal symptoms
Time frame: At week 6 and week 12 of the 12-week course of synbiotic
Intestinal microbiota profile
Time frame: At week 6 and week 12 of the 12-week course of synbiotic
Intestinal metabolites profile
Time frame: At week 6 and week 12 of the 12-week course of synbiotic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wing Ho Wong, MBChB principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week course of synbiotic in people with Autism Spectrum Disorder and Anxiety, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events and side effect (time frame: At week 6 and week 12 of the 12-week course of synbiotic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.