{"id":489,"date":"2019-02-25T16:52:35","date_gmt":"2019-02-25T15:52:35","guid":{"rendered":"http:\/\/www.gemma-project.eu\/?page_id=489"},"modified":"2022-04-13T09:02:53","modified_gmt":"2022-04-13T07:02:53","slug":"families-associations","status":"publish","type":"page","link":"https:\/\/www.gemma-project.eu\/it\/information\/families-associations\/","title":{"rendered":"Famiglie e Associazioni"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"489\" class=\"elementor elementor-489\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-c8706c5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c8706c5\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-184d68a\" data-id=\"184d68a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aff0ae2 elementor-widget elementor-widget-heading\" data-id=\"aff0ae2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FAMILIES AND ASSOCIATIONS<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-3d2dac9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3d2dac9\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-77d514f\" data-id=\"77d514f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4288603 translation-block elementor-widget elementor-widget-text-editor\" data-id=\"4288603\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>GEMMA project will recruit a cohort of 600 infants (age 0-6 months) who have a family history of autism (i.e. siblings of patients with autism) along with their sibling in the condition.  At enrolment, prenatal information (maternal risk factors, maternal infections, etc.) will be collected.<\/p>\n<p>Three <strong> children recruitment centers<\/strong> are involved to allow a global sampling based on their geographical coverage:<\/p>\n<ul>\n<li>National University Of Ireland Galway (NUIG) <a href=\"https:\/\/www.gemma-project.eu\/information\/families-associations\/www.nuigalway.ie\"><strong>www.nuigalway.ie<\/strong><\/a><br>\nIrish Centre for Autism and Neurodevelopment Research (ICAN), Ireland <a href=\"mailto:geraldine.leader@nuigalway.ie\"><strong>geraldine.leader@nuigalway.ie<\/strong><\/a><\/li>\n<li>ASL Salerno, Italy <b><a href=\"mailto:reclutamento@gemma-project.eu\">reclutamento@gemma-project.eu<\/a><\/b><\/li>\n<li>The General Hospital Corporation, MGH, Boston, U.S.A.,<a href=\"https:\/\/www.gemma-project.eu\/information\/families-associations\/www.partners.org\"><strong> www.partners.org<\/strong><\/a>, <a href=\"mailto:mghgemma@mgh.harvard.edu\"><strong>mghgemma@mgh.harvard.edu<\/strong><\/a><\/li>\n<\/ul>\n<div><\/div>\n<p><span style=\"background-color: var(--nv-site-bg); color: var( --e-global-color-text ); font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-size: var(--bodyFontSize); font-weight: var( --e-global-typography-text-font-weight ); letter-spacing: var(--bodyLetterSpacing); text-transform: var(--bodyTextTransform);\">Participants will be evaluated as a child with autism or child without autism based on the Autism Diagnostic Observation Schedule (ADOS) coupled with Toddler Module, a new diagnostic method. The ADOS Toddler evaluation will be conducted every 6 months (starting 12 months of age) and used as the primary. Participants will also be evaluated as children with gastrointestinal (GI) symptoms or children without GI symptoms based on the existence of chronic irregular GI disorders that has not been present since birth.<\/span><\/p>\n<p>All infants will be sampled every 6 months until 36 months for blood, urine, stools and saliva. The samples placed in a biobank so that changes over time of specific gut microbiota, metabolites , gut barrier function, immune, genetic and epigenetic profiles can be assessed over time. At each sampling time point, clinical and dietary data will be recorded.<\/p>\n<p><i>The study provides:<\/i><\/p>\n<p><b>Clinical observational study <\/b>[N=600 infants who have a family history of autism (i.e. siblings of patients with autism)] to prospectively follow from birth a cohort so that the composition and function of the microbiome can be compared in the same subject before and after the possible onset of the condition<\/p>\n<p><u>Inclusion\/exclusion criteria:<br>\n<\/u><em>Inclusion:<\/em> healthy neonates or infants, first degree relatives of ASD individuals (at least one parent or sibling affected by ASD), younger than 6 months\/26 weeks at study entry, have never received solid food (elementary formula feeding is permitted).<br>\n<em>Exclusion:<\/em> neonates with significant health issues (e.g.chronic disease, single gene disorder, FragileX, major brain malformation) that require specific surgical or continuous medical treatments, infants older than 6 months\/26 weeks, infants who have been introduced to solid food, severe GI problems requiring immediate treatment (life-threatening), severely underweight \/malnourished children, dietary restriction in the previous 3 months, tube feeding,drugs since birth that may affect the biomarkers being assessed, for example antibiotics within one month prior to enrolment or antibiotics used as a continuous course for \u226528 days prior to enrolment.<\/p>\n<p><strong style=\"color: var( --e-global-color-text ); font-family: var( --e-global-typography-text-font-family ), Sans-serif; background-color: var(--nv-site-bg); font-size: var(--bodyFontSize); letter-spacing: var(--bodyLetterSpacing); text-transform: var(--bodyTextTransform);\">Clinical interventional study<\/strong><span style=\"color: var( --e-global-color-text ); font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-weight: var( --e-global-typography-text-font-weight ); background-color: var(--nv-site-bg); font-size: var(--bodyFontSize); letter-spacing: var(--bodyLetterSpacing); text-transform: var(--bodyTextTransform);\"> (N=40-60 ASD and ASD-GI children) to test the assumption that <\/span><span style=\"font-family: var( --e-global-typography-text-font-family ), Sans-serif;\"><span style=\"font-weight: var( --e-global-typography-text-font-weight ); letter-spacing: var(--bodyLetterSpacing); text-transform: var(--bodyTextTransform);\">pro\/pre\/symbiotics<\/span><\/span><span style=\"color: var( --e-global-color-text ); font-family: var( --e-global-typography-text-font-family ), Sans-serif; font-weight: var( --e-global-typography-text-font-weight ); background-color: var(--nv-site-bg); font-size: var(--bodyFontSize); letter-spacing: var(--bodyLetterSpacing); text-transform: var(--bodyTextTransform);\"> on specific targeted population stratified by validated biomarkers can attenuate the expression of ASD and co-morbidities.<\/span><\/p>\n<p><u>Inclusion\/exclusion criteria:<\/u><br>\n<em>Inclusion:<\/em> Infants over 18 months of age who have completed the observational study, developed clinical signs \u2028and symptoms of ASD whose parents will permit the intervention in this study to be the sole dietary\/oral \u2028therapy during the study period.<br>\n<em>Exclusion:<\/em> Infants who did not complete the observational study, infants who started any other therapeutic \u2028oral\/medical\/dietary intervention for ASD, any of the exclusion criteria mentioned in the observational study<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-a81c058\" data-id=\"a81c058\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-97bc66b elementor-widget elementor-widget-html\" data-id=\"97bc66b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<!--\n<div class=\"translation-block\">\n<div class=\"uk-card uk-card-default uk-card-body uk-card-hover gemma-slider\">\n\n\n<hr \/>\n\n  \n  \n\n<div  style=\"text-align: justify; \" class=\"translation-block\">\n    <a class=\"uk-link-text\" href=\"htts:\/\/https:\/\/www.gemma-project.eu\/the-project\/\"><b>GEMMA project<\/b><\/a>\n will recruit a cohort of 600 infants of age 0-6 months at-risk of ASD(i.e. siblings of ASD patients) along with their affected ASD sibling. At enrolment, prenatal information (maternal risk factors, maternal infections, etc.) will be collected. <br\/><br\/>\nThree patient <b>recruitment centers<\/b> are involved to allow a global sampling based on their geographical coverage:\n<ul class=\"uk-list uk-list-striped \">\n    \n<li style=\"padding-left:40px;\">National University Of Ireland Galway (NUIG)  \n<a class=\"uk-link-text\" href=\"www.nuigalway.ie\"><b>www.nuigalway.ie<\/b><\/a><br\/>\n Irish Centre for Autism and Neurodevelopment Research (ICAN), Ireland \t\t\t  \t         \n<a class=\"uk-link-text\" href=\"mailto:geraldine.leader@nuigalway.ie\"><b>geraldine.leader@nuigalway.ie<\/b><\/a>\n<\/li>\n<li style=\"padding-left:40px;\" >ASL Salerno, Italy\n<a class=\"uk-link-text\" href=\"http:\/\/www.aslsalerno.it\"><b>www.aslsalerno.it\/<\/b><\/a> , \n<a class=\"uk-link-text\" href=\"mailto:russo.filomenalaura@virgilio.it\"><b>russo.filomenalaura@virgilio.it<\/b><\/a>\n<\/li>\n<li style=\"padding-left:40px;\" >The General Hospital Corporation, MGH, Boston, U.S.A.,<a class=\"uk-link-text\" href=\"www.partners.org\"><b> www.partners.org<\/b><\/a>,  \n<a class=\"uk-link-text\" href=\"mailto:mghgemma@mgh.harvard.edu\"><b>mghgemma@mgh.harvard.edu<\/b><\/a>\n<\/li>\n<li>&nbsp;<\/li>\n<ul>\n    <br\/>\n\n    <p class=\"uk-border-rounded uk-box-shadow-bottom uk-float-right uk-visible@s\" style=\"margin:20px\" >\n<img fetchpriority=\"high\" decoding=\"async\" class=\"uk-border-rounded\"  src=\"https:\/\/www.gemma-project.eu\/wp-content\/uploads\/2019\/02\/pregnant-690735_1920.jpg\" width=\"250\" height=\"250\" alt=\"Authism\">\n<\/p>\n\nParticipants will be evaluated as ASD children or neurocompetent (no ASD) children based on the Autism Diagnostic Observation Schedule (ADOS) coupled with Toddler Module, a new diagnostic method. The ADOS Toddler evaluation will be conducted every 6 months (starting 12 months of age) and used as the primary. Participants will also be evaluated as children with gastointestinal (GI) symptoms or children without GI symptoms based on the existence of chronic irregular GI disorders that has not been present since birth. <br\/><\/br\/>\n\nAll infants will be sampled every 6 months until 36 months for blood, urine, stools and saliva. The samples placed in a biobank so that changes over time of specific gut\n\n <u aria-expanded=\"false\" class=\"uk-inline\"><a class=\"uk-link-heading\" href=\"#\">microbiota<\/a><\/u> <span class=\"uk-dropdown uk-dropdown-bottom-left\"  uk-dropdown=\"mode: hover\">The complex of microorganisms resident in the gut whose composition is linked to health and disease<\/span>\n\n, \n\n <u aria-expanded=\"false\" class=\"uk-inline\"><a class=\"uk-link-heading\" href=\"#\">metabolites<\/a><\/u> <span class=\"uk-dropdown uk-dropdown-bottom-left\"  uk-dropdown=\"mode: hover\">Starting, intermediate or final products of metabolism<\/span>\n\n\n, gut barrier function, immune, genetics and\n\n <u aria-expanded=\"false\" class=\"uk-inline\"><a class=\"uk-link-heading\" href=\"#\">epigenetic<\/a><\/u> <span class=\"uk-dropdown uk-dropdown-bottom-left\"  uk-dropdown=\"mode: hover\">That affect gene expression and activity<\/span>\n \n\nprofiles can be assessed over time. At each sampling time point, clinical and dietary data will be recorded. <br\/><br\/>\n\nThe study provides:<br\/>\n<ul class=\"uk-list  uk-list-large\">\n<li>Clinical observational study (N=600 infants at risk) to prospectivelly follow from birth an at-risk cohort so that the composition and function of the microbiome can be compared in the same subject before and after the possible onset of the disease\u2028<br\/>\n<b>Inclusion\/exclusion criteria:<\/b><br\/>\n<i>Inclusion:<\/i> healthy neonates or infants, first degree relatives of ASD individuals (at least one parent or sibling affected by ASD), younger than 6 months\/26 weeks at study entry, have never received solid food (elementary formula feeding is permitted).<br\/>\n<i>Exclusion:<\/i> neonates with significant health issues (e.g.chronic disease, single gene disorder, FragileX, major brain malformation) that require specific surgical or continuous medical treatments, infants older than 6 months\/26 weeks, infants who have been introduced to solid food, severe GI problems requiring immediate treatment (life-threatening), severely underweight \/malnourished children, dietary restriction in the previous 3 months, tube feeding,drugs since birth that may affect the biomarkers being assessed, for example antibiotics within one month prior to enrolment or antibiotics used as a continuous course for \u226528 days prior to enrolment. \n<\/li>\n<li>Clinical interventional study (N=40-60 ASD and ASD-GI children) to test the assumption that \n\n\n <u aria-expanded=\"false\" class=\"uk-inline\"><a class=\"uk-link-heading\" href=\"#\">pro\/pre\/symbiotics<\/a><\/u> <span class=\"uk-dropdown uk-dropdown-bottom-left\"  uk-dropdown=\"mode: hover\">Pro-symbiotic (or probiotics): live beneficial microorganisms (bacteria and yeasts). Pre-symbiotic (or prebiotics) nutrients promoting the activity or growth of beneficial microorganisms<\/span>\n\non specific targeted population stratified by validated biomarkers can attenuate the expression of ASD and co-morbidities.<br\/>\n\t      <b>Inclusion\/exclusion criteria:<\/b><br\/>\n        <i>Inclusion:<\/i> Infants over 18 months of age who have completed the observational study,\n        developed clinical signs \u2028and symptoms of ASD whose parents will permit the intervention in\n        this study to be the sole dietary\/oral \u2028therapy during the study period.<br\/>\n  <i> Exclusion:<\/i> Infants who did not complete the observational study, infants who started any other\n   therapeutic \u2028oral\/medical\/dietary intervention for ASD, any of the exclusion criteria mentioned     in the observational study\n  <\/li>\n<\/ul>\n\n\n\n<\/div>\n<\/div>\n<\/div>\n-->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>FAMILIES AND ASSOCIATIONS GEMMA project will recruit a cohort of 600 infants (age 0-6 months) who have a family history of autism (i.e. siblings of patients with autism) along with their sibling in the condition. At enrolment, prenatal information (maternal risk factors, maternal infections, etc.) will be collected. Three children recruitment centers are involved to&hellip;&nbsp;<a href=\"https:\/\/www.gemma-project.eu\/it\/information\/families-associations\/\" rel=\"bookmark\">Leggi tutto &raquo;<span class=\"screen-reader-text\">Famiglie e Associazioni<\/span><\/a><\/p>","protected":false},"author":1,"featured_media":0,"parent":241,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-templates\/template-pagebuilder-full-width.php","meta":{"neve_meta_sidebar":"","neve_meta_container":"","neve_meta_enable_content_width":"","neve_meta_content_width":70,"neve_meta_title_alignment":"","neve_meta_author_avatar":"","neve_post_elements_order":"","neve_meta_disable_header":"","neve_meta_disable_footer":"","neve_meta_disable_title":"on","footnotes":""},"class_list":["post-489","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.gemma-project.eu\/it\/wp-json\/wp\/v2\/pages\/489","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.gemma-project.eu\/it\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.gemma-project.eu\/it\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.gemma-project.eu\/it\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.gemma-project.eu\/it\/wp-json\/wp\/v2\/comments?post=489"}],"version-history":[{"count":55,"href":"https:\/\/www.gemma-project.eu\/it\/wp-json\/wp\/v2\/pages\/489\/revisions"}],"predecessor-version":[{"id":1548,"href":"https:\/\/www.gemma-project.eu\/it\/wp-json\/wp\/v2\/pages\/489\/revisions\/1548"}],"up":[{"embeddable":true,"href":"https:\/\/www.gemma-project.eu\/it\/wp-json\/wp\/v2\/pages\/241"}],"wp:attachment":[{"href":"https:\/\/www.gemma-project.eu\/it\/wp-json\/wp\/v2\/media?parent=489"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}