A Phase 1 interventional study of probiotics PS128 and placebo (Microcrystalline cellulose ) in Autism Spectrum Disorder, sponsored by Yan Hao. Status unknown at 1 site in China. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2022-08-31.
Sponsored by Yan Hao · Phase 1, Interventional, and Treatment
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.
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）.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's planned enrollment of 80 is above the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →This is the only study on the registry with Yan Hao as lead sponsor.
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Exclusion Criteria:
Participants 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.
Biological: probiotics PS128 · Drug: placebo (Microcrystalline cellulose )
Participants 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.
Biological: probiotics PS128 · Drug: placebo (Microcrystalline cellulose )
6×10\^10 CFU/capsule
450 mg/capsule
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.
Time frame: Baseline, 8 weeks, 12 weeks and 20 weeks
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.
Time frame: Baseline, 8 weeks, 12 weeks and 20 weeks
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.
Time frame: Baseline, 8 weeks, 12 weeks and 20 weeks
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.
Time frame: Baseline, 8 weeks, 12 weeks and 20 weeks
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.
Time frame: Baseline, 8 weeks, 12 weeks and 20 weeks
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.
Time frame: Baseline, 8 weeks, 12 weeks and 20 weeks
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.
Time frame: Baseline, 8 weeks, 12 weeks and 20 weeks
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.
Time frame: Baseline, 8 weeks, 12 weeks and 20 weeks
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.
Time frame: Baseline, 8 weeks, 12 weeks and 20 weeks
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.
Time frame: Baseline, 8 weeks, 12 weeks and 20 weeks
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.
Time frame: Baseline, 8 weeks, 12 weeks and 20 weeks
Plan to share: No — Data involves children's privacy.
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