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Autism Spectrum DisorderPhase 1NCT04942522

Application of Probiotic PS128 in Children With ASD

A Phase 1 study testing probiotics PS128 in people with Autism Spectrum Disorder, run by Yan Hao at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to explore the role of probiotics PS128 in improving gastrointestinal dysfunction and core behavioral symptoms in children with ASD, and investigate the underlying etiological mechanisms of ASD. Read more about this study

Who is it for?
Ages 2 to 5 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
probiotics PS128
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteChina
Study dates
6 Jun 2021to 6 Oct 2023
Phase
Phase 1
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 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children aged 2-5 years with ASD from Tongji hospital (both boys and girls);
  • meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and ADOS-2 diagnostic criteria;
  • No significant abnormalities on head MRI or EEG;
  • If psychotropic medication is required during the project, the psychiatrist must confirm that medication is stable during this period (no change in dose or type of medication);
  • Willing to provide samples such as blood, urine and feces.

Who cannot join

  • Take antibiotics or antifungal drugs within 15 days prior to the project.
  • Take probiotic products within 30 days prior to the project.
  • Have acute diarrhea within 30 days prior to the project.
  • Start taking new psychotropic medication within 15 days prior to the project.
  • Have severe hearing, visual or motor impairment.
  • Accompany with other mental behavioral disorders, such as schizophrenia, bipolar disorder.
Show all 10Show fewer
  • A history of Rett syndrome, chromosomal, inherited metabolic disorders and other significant somatic disorders.
  • A history of organic gastrointestinal disorders (e.g., gastroesophageal reflux, food allergies, inflammatory bowel disease), history of intestinal surgery, intestinal obstruction, intestinal perforation, intestinal bleeding, multi-organ failure, and severe immunodeficiency disorders
  • Have a special diet (e.g., gluten-free diet, casein-free diet, ketogenic diet, etc.)
  • Co-morbidities in children with ASD were documented and discussed in detail by two or more behavioral developmental behaviorists, and children with ASD who required immediate rehabilitation or neurological analogs for co-morbidities were not allowed to enter this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tongji Hospital

    Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: Application of Probiotic PS128 (Lactobacillus Plantarum, PS128) in Children With Autism Spectrum Disorder (ASD)

The purpose of this study is to explore the role of probiotics PS128 in improving gastrointestinal dysfunction and core behavioral symptoms in children with ASD, and investigate the underlying etiological mechanisms of ASD.

Read the detailed description

After being informed about the study and potential risks, all patients giving written informed consent will undergo screening period to determine eligibility for study entry. Participants who meet the eligibility requirements will be randomized in a double-blind manner(participant and investigator) in a 1:1 ratio to probiotics PS128 group or placebo group. Each patient acts as his or her own control, and they receive both the study drug as well as the placebo. After a washout period, the participants will be switched throughout to different treatments（probiotics placebo group or PS128 group）.

Being tested
probiotics PS128, placebo (Microcrystalline cellulose )
Keywords
ASD, probiotics
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • probiotics PS128Biological

    6×10^10 CFU/capsule

  • placebo (Microcrystalline cellulose )Drug

    450 mg/capsule

Study groups in NCT04942522
Study groupRoleWhat they receive
ASD children AExperimentalParticipants received probiotics PS128 [6×10^10 CFU(colony forming unit)/capsule} one capsule orally twice daily for 8 weeks. After a washout period (4 weeks), they then received placebo(450mg/capsule) one capsule orally twice daily for 8 weeks. Stool, urine and blood specimen will be collected at baseline, week 8, week 12 and week 20.
Receives: Biological: probiotics PS128; Drug: placebo (Microcrystalline cellulose )
ASD children BExperimentalParticipants received placebo(450mg/capsule) one capsule orally twice daily for 8 weeks. After a washout period (4 weeks), they then received probiotics PS128(6×10^10 CFU/capsule) one capsule orally twice daily for 8 weeks. Stool, urine and blood specimen will be collected at baseline, week 8, week 12 and week 20.
Receives: Biological: probiotics PS128; Drug: placebo (Microcrystalline cellulose )

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in Autism Diagnostic Observation Scale (ADOS)

    The ADOS consists of a series of structured and semi-structured tasks that involve social interaction between the examiner and the person under assessment. The examiner observes and identifies segments of the subject's behavior and assigns these to predetermined observational categories. Categorized observations are subsequently combined to produce quantitative scores for analysis and diagnostic classification of ASD. Children at or above predetermined cutoff lines are considered to be positive for ASD. The assessment will be conducted before and after each intervention, namely baseline, 8 weeks, 12 weeks and 20 weeks.

    Measured: Baseline, 8 weeks, 12 weeks and 20 weeks

  2. change in Social Responsiveness Scale (SRS)

    The SRS is a 65-item rating scale with standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows:

    0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment The assessment will be conducted before and after each intervention, namely baseline, 8 weeks, 12 weeks and 20 weeks.

    Measured: Baseline, 8 weeks, 12 weeks and 20 weeks

  3. Change in Social Communication Questionnaire (SCQ)

    The SCQ is a 40-item survey where each question is a 'yes' or 'no' answer. The total possible range of scores is 0-39 (verbal children) or 0-33 (non-verbal children) with higher scores indicative of greater frequency of symptoms. The assessment will be conducted before and after each intervention, namely baseline, 8 weeks, 12 weeks and 20 weeks.

    Measured: Baseline, 8 weeks, 12 weeks and 20 weeks

  4. Change in the Autism Behavior Checklist (ABC)

    ABC is a scale used for nonadaptive behaviors created to screen and indicate the probability of a diagnosis of autism. The questionnaire including 57 items related to five areas: sensorial, relational, use of body and objects, and social skills. Scale score> 67 strongly suggests the presence of autism. The assessment will be conducted before and after each intervention, namely baseline, 8 weeks, 12 weeks and 20 weeks.

    Measured: Baseline, 8 weeks, 12 weeks and 20 weeks

  5. Change in the Childhood Autism Rating Scale (CARS)

    CARS assesses the child on a scale from 1 to 4 in each of 15 dimensions or symptoms. A total score of at least 30 strongly suggests the presence of autism. Children with score between 30 and 36 have mild-to-moderate autism while those with score between 37 and 60 have severe autism. The assessment will be conducted before and after each intervention, namely baseline, 8 weeks, 12 weeks and 20 weeks.

    Measured: Baseline, 8 weeks, 12 weeks and 20 weeks

  6. Change in Gesell developmental scale

    The Gesell developmental scale mainly measures five areas: adaptive behavior, gross motor, fine motor, Language behavior, personal-social behavior, the evaluation finally calculates the developmental quotient (DQ) of each area. Diagnostic criteria: DQ is more than or equal to 86 is normal, DQ is marginal between 76 and 85, DQ is mild mental retardation between 55 and 75, DQ is moderate mental retardation between 40 and 54, DQ is severe mental retardation between 25 and 39, and DQ is less than or equal to 25 is extremely severe mental retardation. The assessment will be conducted before and after each intervention, namely baseline, 8 weeks, 12 weeks and 20 weeks.

    Measured: Baseline, 8 weeks, 12 weeks and 20 weeks

  7. Change in frequency of child behavioral problems

    Child behavioral problems will be assessed using the Externalizing scale of the Child Behavior Checklist (CBCL) for Ages 1.5-5. The Externalizing scale measures child attention problems and aggressive behaviors using 24 items rated by parents based on child performance during the previous two months with a 3-point -type scale. The study will use the CBCL 1.5-5 for all families whose children will be between three to six years old. Lower scores suggest fewer behavioral problems. The assessment will be conducted before and after each intervention, namely baseline, 8 weeks, 12 weeks and 20 weeks.

    Measured: Baseline, 8 weeks, 12 weeks and 20 weeks

  8. Change in frequency of ASD symptoms

    ASD symptoms will be assessed using the Chinese version of the Autism Treatment Evaluation Checklist (ATEC), which comprise four subscales to measure child speech/language/communication, sociability, sensory/cognitive awareness, and health/physical/behavior. The scale has 77 items that are scored by parents. The health/physical/behavior subscale is rated using a 0 (not a problem)-to-3 (serious problem) point scale, whereas the other three subscales are rated using a 0 (not true)-to-2 (very true) point scale. Higher scores represent more ASD symptoms. The assessment will be conducted before and after each intervention, namely baseline, 8 weeks, 12 weeks and 20 weeks.

    Measured: Baseline, 8 weeks, 12 weeks and 20 weeks

  9. change in gastrointestinal symptoms among children with ASD

    Assessment will be conducted for the Rome IV diagnoses of cyclic vomiting, functional vomiting, functional dyspepsia, and/or functional constipation. The presence or absence of meeting criteria for the Rome IV diagnoses will be coded as a binary variable (true/false) to represent resolution of symptoms. The assessment will be conducted before and after each intervention, namely baseline, 8 weeks, 12 weeks and 20 weeks.

    Measured: Baseline, 8 weeks, 12 weeks and 20 weeks

Secondary outcomes (2)

  1. Cytokine Analysis

    Interleukin, Tumor necrosis factor and chemokines will be measured in patient peripheral blood. The analysis will be conducted before and after each intervention, namely baseline, 8 weeks, 12 weeks and 20 weeks.

    Measured: Baseline, 8 weeks, 12 weeks and 20 weeks

  2. Evaluate changes of type, number and structural composition of gut microorganisms in children with ASD.

    Stool routine and 16S-rRNA to evaluate gut microorganisms. The analysis will be conducted before and after each intervention, namely baseline, 8 weeks, 12 weeks and 20 weeks.

    Measured: Baseline, 8 weeks, 12 weeks and 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2021
  2. Study start6 Jun 2021
  3. Primary completion6 Jun 2023 (estimated)
  4. Study completion6 Oct 2023 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04942522
Sponsor's protocol ID
S313
Status last verified
Aug 2022
First submitted
2 Jun 2021
Last updated
31 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data involves children's privacy.

Publications

  • Elsabbagh M, Divan G, Koh YJ, Kim YS, Kauchali S, Marcin C, Montiel-Nava C, Patel V, Paula CS, Wang C, Yasamy MT, Fombonne E. Global prevalence of autism and other pervasive developmental disorders. Autism Res. 2012 Jun;5(3):160-79. doi: 10.1002/aur.239. Epub 2012 Apr 11.

    PubMed 22495912

  • Fombonne E. Epidemiology of pervasive developmental disorders. Pediatr Res. 2009 Jun;65(6):591-8. doi: 10.1203/PDR.0b013e31819e7203.

    PubMed 19218885

  • Xu G, Strathearn L, Liu B, O'Brien M, Kopelman TG, Zhu J, Snetselaar LG, Bao W. Prevalence and Treatment Patterns of Autism Spectrum Disorder in the United States, 2016. JAMA Pediatr. 2019 Feb 1;173(2):153-159. doi: 10.1001/jamapediatrics.2018.4208.

    PubMed 30508021

  • Bailey A, Le Couteur A, Gottesman I, Bolton P, Simonoff E, Yuzda E, Rutter M. Autism as a strongly genetic disorder: evidence from a British twin study. Psychol Med. 1995 Jan;25(1):63-77. doi: 10.1017/s0033291700028099.

    PubMed 7792363

  • Ronald A, Hoekstra RA. Autism spectrum disorders and autistic traits: a decade of new twin studies. Am J Med Genet B Neuropsychiatr Genet. 2011 Apr;156B(3):255-74. doi: 10.1002/ajmg.b.31159. Epub 2011 Jan 13.

    PubMed 21438136

  • de la Torre-Ubieta L, Won H, Stein JL, Geschwind DH. Advancing the understanding of autism disease mechanisms through genetics. Nat Med. 2016 Apr;22(4):345-61. doi: 10.1038/nm.4071.

    PubMed 27050589

  • Grafodatskaya D, Chung B, Szatmari P, Weksberg R. Autism spectrum disorders and epigenetics. J Am Acad Child Adolesc Psychiatry. 2010 Aug;49(8):794-809. doi: 10.1016/j.jaac.2010.05.005. Epub 2010 Jul 3.

    PubMed 20643313

  • Lord C, Risi S, Lambrecht L, Cook EH Jr, Leventhal BL, DiLavore PC, Pickles A, Rutter M. The autism diagnostic observation schedule-generic: a standard measure of social and communication deficits associated with the spectrum of autism. J Autism Dev Disord. 2000 Jun;30(3):205-23.

    PubMed 11055457

  • Frazier TW, Klingemier EW, Beukemann M, Speer L, Markowitz L, Parikh S, Wexberg S, Giuliano K, Schulte E, Delahunty C, Ahuja V, Eng C, Manos MJ, Hardan AY, Youngstrom EA, Strauss MS. Development of an Objective Autism Risk Index Using Remote Eye Tracking. J Am Acad Child Adolesc Psychiatry. 2016 Apr;55(4):301-9. doi: 10.1016/j.jaac.2016.01.011. Epub 2016 Feb 4.

    PubMed 27015721

  • Lai MC, Lombardo MV, Auyeung B, Chakrabarti B, Baron-Cohen S. Sex/gender differences and autism: setting the scene for future research. J Am Acad Child Adolesc Psychiatry. 2015 Jan;54(1):11-24. doi: 10.1016/j.jaac.2014.10.003. Epub 2014 Oct 16.

    PubMed 25524786

  • Shattuck PT, Durkin M, Maenner M, Newschaffer C, Mandell DS, Wiggins L, Lee LC, Rice C, Giarelli E, Kirby R, Baio J, Pinto-Martin J, Cuniff C. Timing of identification among children with an autism spectrum disorder: findings from a population-based surveillance study. J Am Acad Child Adolesc Psychiatry. 2009 May;48(5):474-483. doi: 10.1097/CHI.0b013e31819b3848.

    PubMed 19318992

  • Reinhardt VP, Wetherby AM, Schatschneider C, Lord C. Examination of sex differences in a large sample of young children with autism spectrum disorder and typical development. J Autism Dev Disord. 2015 Mar;45(3):697-706. doi: 10.1007/s10803-014-2223-6.

    PubMed 25189824

  • Rose AJ, Rudolph KD. A review of sex differences in peer relationship processes: potential trade-offs for the emotional and behavioral development of girls and boys. Psychol Bull. 2006 Jan;132(1):98-131. doi: 10.1037/0033-2909.132.1.98.

    PubMed 16435959

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing probiotics PS128 in people with Autism Spectrum Disorder, run by Yan Hao at 1 site in China.

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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 31 Aug 2022. 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 China. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

change in Autism Diagnostic Observation Scale (ADOS) (time frame: Baseline, 8 weeks, 12 weeks and 20 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04942522, which also lists 13 linked publications.

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 31 Aug 2022.

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