Effekter af Lactobacillus Plantarum PS128 hos børn med ASD
2. juli 2026 opdateret af: Chang Gung Memorial Hospital
Virkninger af Lactobacillus Plantarum PS128 hos børn med autismespektrumforstyrrelse
Autismespektrumforstyrrelse (ASD) er en neuroudviklingsforstyrrelse, der kan forårsage betydelige sociale, kommunikations- og adfærdsmæssige underskud.
Probiotika betragtes som aktive mikroorganismer.
Med tilstrækkelige mængder kan probiotika regulere tarmflora, tarmpermeabilitet, inflammation og antioxidantreaktioner i kroppen.
Disse reaktioner kan yderligere fremme sundheden, regulere metabolisk sygdomsprogression og forhindre komplikationer.
Lactobacillus plantarum PS128 (PS128) blev rapporteret at være et psykobiotikum i flere dyre- og menneskestudier, som modulerede niveauerne af neurotransmittere i forskellige hjerneområder.
Denne undersøgelse skal evaluere, om forbruget af PS128 kan forbedre symptomerne hos patienter med ASD.
Det nuværende randomiserede, placebokontrollerede forsøg blev udført for at undersøge de psykofysiologiske virkninger af PS128 hos skolebørn med ASD.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
41
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Taoyuan, Taiwan
- Chang Gung Memorial Hospital
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
7 år til 12 år (Barn)
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
- (1) Alder 7 til 12 år.
- (2) PS128-gruppe og placebogruppe: Børn med autismespektrumforstyrrelse, bekræftet af Autism Diagnostic Observation Schedule.
- (3) Normal kontrolgruppe: Børn uden autismespektrumforstyrrelse.
Ekskluderingskriterier:
- (1) Modtagelse af antibiotika inden for en måned.
- (2) Probiotika brugt i pulver, kapsel eller tablet om to uger (undtagen yoghurt, yoghurt, Yakult og andre relaterede fødevarer).
- (3) Patienter med hepatobiliær mave-tarmkanal, som er blevet opereret (undtagen brokoperation og blindtarmsoperation)
- (4) Dem med specielle diæter (glutenfri, kaseinfri, proteinrig og ketogen diæt).
- (5) Dem med en historie med kræft.
- (6) Dem, der er allergiske over for mælkesyrebakterier.
- (7) Ikke berettiget vurderet af PI
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: PS128
Forsøgspersoner vil tage PS128-kapsler hver dag (2 kapsler/dag, én gang) i 12 uger.
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Hver PS128-kapsel indeholdt >3 × 10^10 kolonidannende enheder (CFU) med mikrokrystallinsk cellulose og vægte 425 ± 25 mg.
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Placebo komparator: Placebo
Forsøgspersonerne vil tage placebokapsler hver dag (2 kapsler/dag, én gang) i 12 uger.
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Placebokapslerne indeholdt kun 425 ± 25 mg mikrokrystallinsk cellulose.
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Ingen indgriben: Normal kontrol
Normal kontrolgruppe tilmeldes efter invitation fra de alders- og kønsmatchede raske børn.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
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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
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
|
|
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.
|
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
|
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
|
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.
|
Baseline and Week 12
|
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Functional MRI (Resting-state/Biological Motion Task) - BOLD Signal
Tidsramme: Baseline and Week 12
|
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
|
|
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.
|
Baseline and Week 12
|
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Safety Assessment - Albumin
Tidsramme: Baseline and Week 12
|
Safety is assessed function of liver and kidney such as albumin (3.5-5.4 g/dl).
|
Baseline and Week 12
|
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Safety Assessment - Total Protein
Tidsramme: Baseline and Week 12
|
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
|
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
|
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
|
Safety is assessed function of liver and kidney such as T-Cholesterol (<170 mg/dL).
|
Baseline and Week 12
|
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Safety Assessment - Uric Acid
Tidsramme: Baseline and Week 12
|
Safety is assessed function of liver and kidney such as uric acid (<7.0 mg/dl).
|
Baseline and Week 12
|
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Safety Assessment - BUN
Tidsramme: Baseline and Week 12
|
Safety is assessed function of liver and kidney such as BUN (7-25 mg/dl).
|
Baseline and Week 12
|
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Safety Assessment - Creatinine
Tidsramme: Baseline and Week 12
|
Safety is assessed function of liver and kidney such as creatinine (0.2-1.0 mg/dl).
|
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
|
|
Change in Levels of Exploratory Blood-based Biomarkers for Inflammatory Changes - MPO
Tidsramme: Baseline and Week 12
|
Inflammatory is assessed via a composite measure of circulating cytokines - MPO (ng/mL)
|
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
|
|
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
|
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).
|
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
|
Oxidative stress is assessed via Cortisol (6-10am 4.82-19.5,
4-8pm 2.47-11.9,
μg/dl).
|
Baseline and Week 12
|
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. juli 2022
Primær færdiggørelse (Faktiske)
3. april 2024
Studieafslutning (Faktiske)
3. april 2024
Datoer for studieregistrering
Først indsendt
14. marts 2022
Først indsendt, der opfyldte QC-kriterier
24. marts 2022
Først opslået (Faktiske)
1. april 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. juli 2026
Sidst verificeret
1. februar 2025
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 202101416A3
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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