Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568588
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Effects of Probiotic Consumption in Children With Autism Spectrum Disorder ASD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Probiotic Consumption in Children With Autism Spectrum Disorder ASD in the Metropolitan District of Quito Ecuador
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to determine the effects of Saccharomyces boulardii Sb consumption on Ecuadorian children with a diagnosis of autism spectrum disorder ASD and digestive symptoms Saccharomyces boulardii is a probiotic in other words a beneficial microorganism The main question it aims to answer is Does Sb improve intestinal health defenses against infections nutrition and behavior of the participants Researchers will compare children when they are taking and not taking Saccharomyces boulardii to know if there are changes in digestive symptoms immune system function nutritional status and behavior Participants will take Saccharomyces boulardii for 4 months and will be 4 months without taking Sb All participants must provide stool urine and blood samples A medical nutritional and psychological team will follow the participants at least 5 times during the study
Detailed Description:
Autism Spectrum disorder ASD is a group of neurodevelopmental abnormalities that begin in early childhood frequently characterized by problems in communication and social behavior Metabolites produced by the gut microbiome may affect gastrointestinal Gl tract and central nervous system CNS functions supporting the presence of the gut- brain-axis Previous studies have demonstrated changes in the intestinal microbiome in children with ASD compared with neurotypical controls It is possible that dietary modifications including the use of probiotics in children with ASD could positively modify Gl and CNS functions Few clinical studies have been carried out to assess the effects of probiotic consumption by children with ASD on their microbiota composition intestinal function and behavior in developing countries Consequently the general objective of the study is to determine the effects of probiotics supplementation in gut microbiota composition nutritional status and immune status in children with ASD
A randomized crossover study will be conducted including children diagnosed with ASD living within the Metropolitan District of Quito After verifying the inclusion and exclusion criteria 66 participants will be selected Initially children diagnosed with ASD will be randomly organized into 2 groups Group A n33 will receive Sb supplements at a dose of 250 mg 3 times a day for a period of 4 months While Group B n33 will not receive supplementation for 4 months This will be followed by a 30-day washout period during which time neither group consumes probiotics After this time the childrens groups will change treatment for another four months The investigators will analyze behavior gut microbiome metabolome nutritional status and gastrointestinal symptoms to determine the changes caused by Sb consumption Participants will be followed up at months 1 4 5 9 10 of the study At each follow-up stool blood and urine samples will be collected for the different analyzes
A sociodemographic survey will be applied to determine the epidemiological parameters of the participants The behavioral parameters of each child will be evaluated by means of psychological assessments Tests that will be applied are Autism Diagnostic Observation Schedule Second Edition ADOS- 2 Autism Diagnostic Interview-Revised ADI-R Wechsler Intelligence Scale for Children WISC Adaptive Behavior Assessment System ABAS Wechsler Preschool and Primary Scale of Intelligence WPPSI Battelle Developmental Inventory BATELLE For the evaluation of nutritional status anthropometric measurements weight height BMI will be taken and percentiles and Z-scores will be calculated In addition a 24-hour recall questionnaire will be applied Roma IV test will be applied to evaluate gastrointestinal symptoms To determine the immunological status the investigators will measure interleukins and growth factors in blood
Regarding the analysis of the gut microbiota the investigators will start with DNA extraction from stool samples All raw sequences obtained from the Illumina sequencer will be analyzed to determine taxonomic composition alpha and beta diversity functional annotation and differential microbial relative abundance between the two groups Functional annotation will be performed using Human Microbiome Project Unified Metabolic Analysis Network HumanN software Taxonomic assignment will be done using Metagenomic Phylogenetic Analysis Metaphlan software Diversity metrics will be calculated using the Vegan diversity R package To compare alpha diversity analysis Chao 1 Shannon and Simpsons index will be calculated For Beta diversity comparison the Analysis of Ecological Data ade4 function in the R package will be used to generate principal component analysis using Bray-Curtis Jaccard unweighted Unifrac and weighted Unifrac distance metrics Linear discriminant analysis will be used in conjunction with the sample size effect measurement test LEfSe to perform differential microbial relative abundance analysis between the two groups
The investigators will perform metabolome analysis on blood fecal samples and urine Metabolome assignment will be by 2D experiments based on signal in Proton nuclear magnetic resonance H-NMR using the human metabolome database and the biological magnetic resonance metabolome database
A randomized crossover study will be conducted including children diagnosed with ASD living within the Metropolitan District of Quito After verifying the inclusion and exclusion criteria 66 participants will be selected Initially children diagnosed with ASD will be randomly organized into 2 groups Group A n33 will receive Sb supplements at a dose of 250 mg 3 times a day for a period of 4 months While Group B n33 will not receive supplementation for 4 months This will be followed by a 30-day washout period during which time neither group consumes probiotics After this time the childrens groups will change treatment for another four months The investigators will analyze behavior gut microbiome metabolome nutritional status and gastrointestinal symptoms to determine the changes caused by Sb consumption Participants will be followed up at months 1 4 5 9 10 of the study At each follow-up stool blood and urine samples will be collected for the different analyzes
A sociodemographic survey will be applied to determine the epidemiological parameters of the participants The behavioral parameters of each child will be evaluated by means of psychological assessments Tests that will be applied are Autism Diagnostic Observation Schedule Second Edition ADOS- 2 Autism Diagnostic Interview-Revised ADI-R Wechsler Intelligence Scale for Children WISC Adaptive Behavior Assessment System ABAS Wechsler Preschool and Primary Scale of Intelligence WPPSI Battelle Developmental Inventory BATELLE For the evaluation of nutritional status anthropometric measurements weight height BMI will be taken and percentiles and Z-scores will be calculated In addition a 24-hour recall questionnaire will be applied Roma IV test will be applied to evaluate gastrointestinal symptoms To determine the immunological status the investigators will measure interleukins and growth factors in blood
Regarding the analysis of the gut microbiota the investigators will start with DNA extraction from stool samples All raw sequences obtained from the Illumina sequencer will be analyzed to determine taxonomic composition alpha and beta diversity functional annotation and differential microbial relative abundance between the two groups Functional annotation will be performed using Human Microbiome Project Unified Metabolic Analysis Network HumanN software Taxonomic assignment will be done using Metagenomic Phylogenetic Analysis Metaphlan software Diversity metrics will be calculated using the Vegan diversity R package To compare alpha diversity analysis Chao 1 Shannon and Simpsons index will be calculated For Beta diversity comparison the Analysis of Ecological Data ade4 function in the R package will be used to generate principal component analysis using Bray-Curtis Jaccard unweighted Unifrac and weighted Unifrac distance metrics Linear discriminant analysis will be used in conjunction with the sample size effect measurement test LEfSe to perform differential microbial relative abundance analysis between the two groups
The investigators will perform metabolome analysis on blood fecal samples and urine Metabolome assignment will be by 2D experiments based on signal in Proton nuclear magnetic resonance H-NMR using the human metabolome database and the biological magnetic resonance metabolome database
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None