Effekter av Lactobacillus Plantarum PS128 hos barn med ASD
2. juli 2026 oppdatert av: Chang Gung Memorial Hospital
Effekter av Lactobacillus Plantarum PS128 hos barn med autismespektrumforstyrrelse
Autismespektrumforstyrrelse (ASD) er en nevroutviklingsforstyrrelse som kan forårsake betydelige sosiale, kommunikasjons- og atferdsvansker.
Probiotika regnes som aktive mikroorganismer.
Med tilstrekkelige mengder kan probiotika regulere tarmfloraen, tarmpermeabiliteten, betennelser og antioksidantreaksjoner i kroppen.
Disse reaksjonene kan ytterligere fremme helse, regulere metabolsk sykdomsprogresjon og forhindre komplikasjoner.
Lactobacillus plantarum PS128 (PS128) ble rapportert å være et psykobiotikum i flere dyre- og menneskestudier som modulerte nivåene av nevrotransmittere i forskjellige hjerneområder.
Denne studien skal evaluere om forbruket av PS128 kan forbedre symptomene til pasienter med ASD.
Den nåværende randomiserte, placebokontrollerte studien ble utført for å undersøke de psykofysiologiske effektene av PS128 hos skolebarn med ASD.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
41
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Taoyuan, Taiwan
- Chang Gung Memorial Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
7 år til 12 år (Barn)
Tar imot friske frivillige
Ja
Beskrivelse
Inklusjonskriterier:
- (1) Alder 7 til 12 år gammel.
- (2) PS128-gruppe og placebogruppe: Barn med autismespekterforstyrrelse, bekreftet av Autism Diagnostic Observation Schedule.
- (3) Normal kontrollgruppe: Barn uten autismespekterforstyrrelse.
Ekskluderingskriterier:
- (1) Motta antibiotika innen en måned.
- (2) Probiotika brukt i pulver, kapsel eller tablett om to uker (unntatt yoghurt, yoghurt, Yakult og andre relaterte matvarer).
- (3) Pasienter med lever og galle i mage-tarmkanalen som har gjennomgått operasjon (unntatt brokkoperasjon og blindtarmsoperasjon)
- (4) De med spesielle dietter (glutenfri, kaseinfri, proteinrik og ketogen diett).
- (5) De med en historie med kreft.
- (6) De som er allergiske mot melkesyrebakterier.
- (7) Ikke kvalifisert bedømt av PI
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: PS128
Forsøkspersonene vil ta PS128-kapsler hver dag (2 kapsler/dag, én gang) i 12 uker.
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Hver PS128-kapsel inneholdt >3 × 10^10 kolonidannende enheter (CFU) med mikrokrystallinsk cellulose og vekter 425 ± 25 mg.
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Placebo komparator: Placebo
Forsøkspersonene vil ta placebokapsler hver dag (2 kapsler/dag, én gang) i 12 uker.
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Placebokapslene inneholdt kun 425 ± 25 mg mikrokrystallinsk cellulose.
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Ingen inngripen: Normal kontroll
Normale kontrollgrupper registreres etter invitasjon fra friske barn med alder og kjønn.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Changes of Total Scores of Social Responsiveness Scale
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Changes of Total Scores of Repetitive Behavior Scale-Revised
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, week 12 and Week 16
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, Week 12 and Week 16
|
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
Tidsramme: Baseline, Week 12 and Week 16
|
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
Tidsramme: Baseline, Week 12 and Week 16
|
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
Tidsramme: Week 12 and Week 16
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).
|
Baseline and Week 12
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Safety Assessment - ALP
Tidsramme: Baseline and Week 12
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Safety is assessed function of liver and kidney such as ALP (135-320 U/L).
|
Baseline and Week 12
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Safety Assessment - Total Bilirubin
Tidsramme: 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).
|
Baseline and Week 12
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Safety Assessment - T-Cholesterol
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and Week 12
|
Safety is assessed function of liver and kidney such as AST (13-40 U/L).
|
Baseline and Week 12
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Safety Assessment - ALT
Tidsramme: Baseline and Week 12
|
Safety is assessed function of liver and kidney such as ALT (7-40 U/L).
|
Baseline and Week 12
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Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - MPO
Tidsramme: 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
Tidsramme: Baseline and Week 12
|
Inflammatory is assessed via a composite measure of circulating cytokines - IL-1β (pg/mL)
|
Baseline and Week 12
|
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Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - TGF-β1
Tidsramme: Baseline and Week 12
|
Inflammatory is assessed via a composite measure of circulating cytokines - TGF-β1 (pg/mL)
|
Baseline and Week 12
|
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Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - Eotaxin
Tidsramme: Baseline and Week 12
|
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
Tidsramme: Baseline and Week 12
|
Inflammatory is assessed via a composite measure of circulating cytokines - IL-6 (ng/mL)
|
Baseline and Week 12
|
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Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - Serotonin
Tidsramme: Baseline and Week 12
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Oxidative stress is assessed via Serotonin (ng/mL).
|
Baseline and Week 12
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Change in Levels of Exploratory Blood-based Biomarkers for Oxidative Stress Changes - GABA
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Baseline and Week 12
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Samarbeidspartnere og etterforskere
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Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. juli 2022
Primær fullføring (Faktiske)
3. april 2024
Studiet fullført (Faktiske)
3. april 2024
Datoer for studieregistrering
Først innsendt
14. mars 2022
Først innsendt som oppfylte QC-kriteriene
24. mars 2022
Først lagt ut (Faktiske)
1. april 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juli 2026
Sist bekreftet
1. februar 2025
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 202101416A3
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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