Effekter av Lactobacillus Plantarum PS128 hos barn med ASD
2 juli 2026 uppdaterad av: Chang Gung Memorial Hospital
Effekter av Lactobacillus Plantarum PS128 hos barn med autismspektrumstörning
Autismspektrumstörning (ASD) är en neuroutvecklingsstörning som kan orsaka betydande sociala, kommunikations- och beteendemässiga brister.
Probiotika betraktas som aktiva mikroorganismer.
Med tillräckliga mängder kan probiotika reglera tarmflora, tarmpermeabilitet, inflammation och antioxidantreaktioner i kroppen.
Dessa reaktioner kan ytterligare främja hälsan, reglera metabolisk sjukdomsprogression och förhindra komplikationer.
Lactobacillus plantarum PS128 (PS128) rapporterades vara ett psykobiotikum i flera djur- och humanstudier som modulerade nivåerna av neurotransmittorer i olika hjärnområden.
Denna studie är för att utvärdera om konsumtionen av PS128 kan förbättra symtomen hos patienter med ASD.
Den nuvarande randomiserade, placebokontrollerade studien genomfördes för att undersöka de psykofysiologiska effekterna av PS128 hos skolbarn med ASD.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
41
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Taoyuan, Taiwan
- Chang Gung Memorial Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
7 år till 12 år (Barn)
Tar emot friska volontärer
Ja
Beskrivning
Inklusionskriterier:
- (1) Ålder 7 till 12 år gammal.
- (2) PS128-grupp och placebogrupp: Barn med autismspektrumstörning, bekräftad av Autism Diagnostic Observation Schedule.
- (3) Normal kontrollgrupp: Barn utan autismspektrumstörning.
Exklusions kriterier:
- (1) Få antibiotika inom en månad.
- (2) Probiotika används i pulver, kapslar eller tabletter inom två veckor (förutom yoghurt, yoghurt, Yakult och andra relaterade livsmedel).
- (3) Patienter med lever och gallvägar i mag-tarmkanalen som har genomgått operation (förutom bråckoperation och blindtarmsoperation)
- (4) De med specialdieter (glutenfri, kaseinfri, proteinrik och ketogen kost).
- (5) De med en historia av cancer.
- (6) De som är allergiska mot mjölksyrabakterier.
- (7) Ej kvalificerad bedömd av PI
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: PS128
Försökspersonerna kommer att ta PS128-kapslar varje dag (2 kapslar/dag, en gång) i 12 veckor.
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Varje PS128-kapsel innehöll >3 × 10^10 kolonibildande enheter (CFU) med mikrokristallin cellulosa och vikten 425 ± 25 mg.
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Placebo-jämförare: Placebo
Försökspersonerna kommer att ta placebokapslar varje dag (2 kapslar/dag, en gång) i 12 veckor.
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Placebokapslarna innehöll endast 425 ± 25 mg mikrokristallin cellulosa.
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Inget ingripande: Normal kontroll
Normala kontrollgrupper skrivs in på inbjudan från ålders- och könsmatchade friska barn.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Changes of Total Scores of Social Responsiveness Scale
Tidsram: Baseline, Week 12 and Week 16
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Social Responsiveness Scale can measure the autism clinical severity with the range from 65-260.
The lower scores stand for better social responsiveness.
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Baseline, Week 12 and Week 16
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Changes of Total Scores of Repetitive Behavior Scale-Revised
Tidsram: Baseline, Week 12 and Week 16
|
Repetitive Behavior Scale-Revised is a questionnaire that focuses on repetitive behavior.
The score ranges from 0-129.
The lower scores stand for lower repetitive behavior.
|
Baseline, Week 12 and Week 16
|
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Changes of Total Scores of Child Behavior Checklist
Tidsram: Baseline, Week 12 and Week 16
|
Child Behavior Checklist is a parents' report questionnaire for behavioral and emotional problems.
The score ranges from 0-240.
The lower scores stand for better behavioral and emotional regulation.
|
Baseline, Week 12 and Week 16
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Changes of Total Scores of Adaptive Behavior Assessment System
Tidsram: Baseline, week 12 and Week 16
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Adaptive Behavior Assessment System is a parents' report questionnaire for adaptive behavior.
The score ranges from 9-171.
The higher scores stand for better adaptive behavior.
|
Baseline, week 12 and Week 16
|
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Changes in Accuracy of Frith-Happe Animation
Tidsram: Baseline, Week 12 and Week 16
|
A quick and objective test of Theory of Mind.
8 questions in total, the more correct questions stand for better Social Cognition.
|
Baseline, Week 12 and Week 16
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Changes in Accuracy of Eyes Task
Tidsram: Baseline, Week 12 and Week 16
|
An advanced test for Theory of Mind.
43 questions in total, the more correct questions stand for better social skills.
|
Baseline, Week 12 and Week 16
|
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Changes of Total Scores of Aberrant Behavior Checklist
Tidsram: Baseline, Week 12 and Week 16
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Aberrant Behavior Checklist is a parents' report questionnaire for aberrant behavior.
The score ranges from 0-174.
The lower scores stand for less aberrant behavior.
|
Baseline, Week 12 and Week 16
|
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Changes of Total Scores of Emotional Dysregulation Inventory
Tidsram: Baseline, Week 12 and Week 16
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Emotional Dysregulation Inventory is a parents' report questionnaire for emotional dysregulation.
The score ranges from 0-120.
The lower scores stand for better emotional regulation.
|
Baseline, Week 12 and Week 16
|
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Changes of Total Scores of Parenting Stress Index, Fourth Editon
Tidsram: Baseline, Week 12 and Week 16
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Parenting Stress Index is a parents' report questionnaire for parenting stress.
The score ranges from 0-180.
The lower scores stand for lower parenting stress.
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Baseline, Week 12 and Week 16
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Assessment of Clinical Global Impression-Severity of Illness
Tidsram: Week 12 and Week 16
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The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment.
The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.
The score ranges from 1-7.
CGI Improvement scale: 1=very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse.
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Week 12 and Week 16
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Assessment of Patient Global Impression of Change
Tidsram: Week 12 and Week 16
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The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment.
PGIC is a 7 point scale depicting a patient's rating of overall improvement.
The score ranges from 1-7.
Patients rate their change as "1=very much improved ," "2=much improved," "3=minimally improved," "4=no change," "5=minimally worse," "6=much worse," or "7=very much worse)."
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Week 12 and Week 16
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Gut Microbiota-Relative Abundance of Bifidobacterium Faecale
Tidsram: Baseline and Week 12
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Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota as well as short chain fatty acids in Stool samples.
The 16S rRNA gene amplicons will be prepared following the Illumina protocol for preparing the 16S metagenomic sequencing library.
Values represent percentages and range from 0 to 100%, with higher values indicating a higher relative abundance of the target bacterium in the gut microbiota
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Baseline and Week 12
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MRI T1
Tidsram: Baseline and Week 12
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Brain structural volumes (cm²).
The advanced processing and analysis of the MRI data have been outsourced to an external core facility.
Due to resource scheduling and the prolonged timeline required for specialized image preprocessing, the data analysis is currently in progress and has not yet been finalized.
Therefore, quantifiable results are unavailable for summary in the data table at this time.
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Baseline and Week 12
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Functional MRI (Resting-state/Biological Motion Task) - BOLD Signal
Tidsram: Baseline and Week 12
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Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.
The advanced processing and analysis of the MRI data have been outsourced to an external core facility.
Due to resource scheduling and the prolonged timeline required for specialized image preprocessing, the data analysis is currently in progress and has not yet been finalized.
Therefore, quantifiable results are unavailable for summary in the data table at this time.
|
Baseline and Week 12
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Diffusion Tensor Imaging (DTI) - FA
Tidsram: Baseline and Week 12
|
Fractional anisotropy (FA) is a measurement used in DTI, which reflects the movement of water molecules.
FA ranges from 0 to 1, the higher FA value may represent more intact axons.
The advanced processing and analysis of the MRI data have been outsourced to an external core facility.
Due to resource scheduling and the prolonged timeline required for specialized image preprocessing, the data analysis is currently in progress and has not yet been finalized.
Therefore, quantifiable results are unavailable for summary in the data table at this time.
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Baseline and Week 12
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Safety Assessment - Albumin
Tidsram: Baseline and Week 12
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Safety is assessed function of liver and kidney such as albumin (3.5-5.4 g/dl).
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Baseline and Week 12
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Safety Assessment - Total Protein
Tidsram: Baseline and Week 12
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Safety is assessed function of liver and kidney such as total protein (6.4-8.3 g/dl).
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Baseline and Week 12
|
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Safety Assessment - ALP
Tidsram: Baseline and Week 12
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Safety is assessed function of liver and kidney such as ALP (135-320 U/L).
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Baseline and Week 12
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Safety Assessment - Total Bilirubin
Tidsram: Baseline and Week 12
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Safety is assessed function of liver and kidney such as total bilirubin (0.3-1.2 mg/dl).
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Baseline and Week 12
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Safety Assessment - T-Cholesterol
Tidsram: Baseline and Week 12
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Safety is assessed function of liver and kidney such as T-Cholesterol (<170 mg/dL).
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Baseline and Week 12
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Safety Assessment - Uric Acid
Tidsram: Baseline and Week 12
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Safety is assessed function of liver and kidney such as uric acid (<7.0 mg/dl).
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Baseline and Week 12
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Safety Assessment - BUN
Tidsram: Baseline and Week 12
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Safety is assessed function of liver and kidney such as BUN (7-25 mg/dl).
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Baseline and Week 12
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Safety Assessment - Creatinine
Tidsram: Baseline and Week 12
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Safety is assessed function of liver and kidney such as creatinine (0.2-1.0 mg/dl).
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Baseline and Week 12
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Safety Assessment - AST
Tidsram: Baseline and Week 12
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Safety is assessed function of liver and kidney such as AST (13-40 U/L).
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Baseline and Week 12
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Safety Assessment - ALT
Tidsram: Baseline and Week 12
|
Safety is assessed function of liver and kidney such as ALT (7-40 U/L).
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Baseline and Week 12
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Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - MPO
Tidsram: Baseline and Week 12
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Inflammatory is assessed via a composite measure of circulating cytokines - MPO (ng/mL)
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Baseline and Week 12
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Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - IL-1β
Tidsram: Baseline and Week 12
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Inflammatory is assessed via a composite measure of circulating cytokines - IL-1β (pg/mL)
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Baseline and Week 12
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Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - TGF-β1
Tidsram: Baseline and Week 12
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Inflammatory is assessed via a composite measure of circulating cytokines - TGF-β1 (pg/mL)
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Baseline and Week 12
|
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Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - Eotaxin
Tidsram: Baseline and Week 12
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Inflammatory is assessed via a composite measure of circulating cytokines - Eotaxin (pg/mL)
|
Baseline and Week 12
|
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Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - IL-6
Tidsram: Baseline and Week 12
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Inflammatory is assessed via a composite measure of circulating cytokines - IL-6 (ng/mL)
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Baseline and Week 12
|
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Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - Serotonin
Tidsram: Baseline and Week 12
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Oxidative stress is assessed via Serotonin (ng/mL).
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Baseline and Week 12
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Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - GABA
Tidsram: Baseline and Week 12
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Oxidative stress is assessed via GABA (μmol/L).
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Baseline and Week 12
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Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - Cortisol
Tidsram: Baseline and Week 12
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Oxidative stress is assessed via Cortisol (6-10am 4.82-19.5,
4-8pm 2.47-11.9,
μg/dl).
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Baseline and Week 12
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Gut Microbiota-Relative Abundance of Lactiplantibacillus Plantarum
Tidsram: Baseline and Week 12
|
Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota as well as short chain fatty acids in Stool samples.
The 16S rRNA gene amplicons will be prepared following the Illumina protocol for preparing the 16S metagenomic sequencing library.
Values represent percentages and range from 0 to 100%, with higher values indicating a higher relative abundance of the target bacterium in the gut microbiota.
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Baseline and Week 12
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 juli 2022
Primärt slutförande (Faktisk)
3 april 2024
Avslutad studie (Faktisk)
3 april 2024
Studieregistreringsdatum
Först inskickad
14 mars 2022
Först inskickad som uppfyllde QC-kriterierna
24 mars 2022
Första postat (Faktisk)
1 april 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 juli 2026
Senast verifierad
1 februari 2025
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 202101416A3
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