Efectos de Lactobacillus Plantarum PS128 en niños con TEA
2 de julio de 2026 actualizado por: Chang Gung Memorial Hospital
Efectos de Lactobacillus Plantarum PS128 en niños con trastorno del espectro autista
El trastorno del espectro autista (TEA) es un trastorno del neurodesarrollo que puede causar importantes déficits sociales, de comunicación y de comportamiento.
Los probióticos se consideran microorganismos activos.
Con cantidades suficientes, los probióticos pueden regular la flora intestinal, la permeabilidad intestinal, la inflamación y las reacciones antioxidantes en el cuerpo.
Estas reacciones pueden promover aún más la salud, regular la progresión de la enfermedad metabólica y prevenir complicaciones.
Se informó que Lactobacillus plantarum PS128 (PS128) es un psicobiótico en varios estudios con animales y humanos que modulan los niveles de neurotransmisores en diferentes áreas del cerebro.
Este estudio es para evaluar si el consumo de PS128 puede mejorar los síntomas de los pacientes con TEA.
El ensayo aleatorizado controlado con placebo actual se llevó a cabo para investigar los efectos psicofisiológicos de PS128 en escolares con TEA.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
41
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
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Taoyuan, Taiwán
- Chang Gung Memorial Hospital
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
7 años a 12 años (Niño)
Acepta Voluntarios Saludables
Sí
Descripción
Criterios de inclusión:
- (1) Edad de 7 a 12 años.
- (2) Grupo PS128 y grupo placebo: niños con trastorno del espectro autista, confirmado por el programa de observación de diagnóstico de autismo.
- (3) Grupo de control normal: niños sin trastorno del espectro autista.
Criterio de exclusión:
- (1) Recibir antibióticos dentro de un mes.
- (2) Probióticos utilizados en polvo, cápsula o tableta en dos semanas (excepto Yogurt, Yogurt, Yakult y otros alimentos relacionados).
- (3) Pacientes con tracto gastrointestinal hepatobiliar que se han sometido a cirugía (excepto cirugía de hernia y apendicectomía)
- (4) Aquellos con dietas especiales (dieta sin gluten, sin caseína, alta en proteínas y cetogénica).
- (5) Aquellos con antecedentes de cáncer.
- (6) Aquellos que son alérgicos a las bacterias del ácido láctico.
- (7) No elegible juzgado por PI
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: PS128
Los sujetos tomarán cápsulas de PS128 todos los días (2 cápsulas/día, una vez) durante 12 semanas.
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Cada cápsula de PS128 contenía >3 × 10^10 unidades formadoras de colonias (UFC) con celulosa microcristalina y pesaba 425 ± 25 mg.
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Comparador de placebos: Placebo
Los sujetos tomarán cápsulas de placebo todos los días (2 cápsulas/día, una vez) durante 12 semanas.
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Las cápsulas de placebo solo contenían 425 ± 25 mg de celulosa microcristalina.
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Sin intervención: Controles normales
El grupo de control normal se inscribe por invitación de niños sanos de la misma edad y sexo.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes of Total Scores of Social Responsiveness Scale
Periodo de tiempo: Baseline, Week 12 and Week 16
|
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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes of Total Scores of Repetitive Behavior Scale-Revised
Periodo de tiempo: 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.
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Baseline, Week 12 and Week 16
|
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Changes of Total Scores of Child Behavior Checklist
Periodo de tiempo: 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.
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Baseline, Week 12 and Week 16
|
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Changes of Total Scores of Adaptive Behavior Assessment System
Periodo de tiempo: 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.
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Baseline, week 12 and Week 16
|
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Changes in Accuracy of Frith-Happe Animation
Periodo de tiempo: 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.
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Baseline, Week 12 and Week 16
|
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Changes in Accuracy of Eyes Task
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Diffusion Tensor Imaging (DTI) - FA
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline and Week 12
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline and Week 12
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Inflammatory is assessed via a composite measure of circulating cytokines - Eotaxin (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 - IL-6
Periodo de tiempo: Baseline and Week 12
|
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
Periodo de tiempo: Baseline and Week 12
|
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
Periodo de tiempo: 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
Periodo de tiempo: Baseline and Week 12
|
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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de julio de 2022
Finalización primaria (Actual)
3 de abril de 2024
Finalización del estudio (Actual)
3 de abril de 2024
Fechas de registro del estudio
Enviado por primera vez
14 de marzo de 2022
Primero enviado que cumplió con los criterios de control de calidad
24 de marzo de 2022
Publicado por primera vez (Actual)
1 de abril de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de julio de 2026
Última verificación
1 de febrero de 2025
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 202101416A3
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .