xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06005506</url>
    </required_header>
    <id_info>
      <org_study_id>NM102_SPATIALS3</org_study_id>
      <nct_id>NCT06005506</nct_id>
    </id_info>
    <brief_title>National Multicenter Interventional Study Aimed at Evaluating the Effect on the Intestinal Microbiota in Chronically Frail Patients Who Share Alterations in Intestinal Function.</brief_title>
    <acronym>sPATIALS3</acronym>
    <official_title>'sPATIALS3' - National Multicenter Randomized Controlled Interventional Study, Comparing an Active Symbiotic and a Passive Symbiotic Aimed at Evaluating the Effect on the Intestinal Microbiota and on the State of Health and Well-being of Various Types of Chronically Frail Patients United by Alterations of Intestinal Function.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institute of Biomedical Technologies-National Research Council, Italy</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Fondazione Serena Onlus - Centro Clinico NeMO Milano</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>IRCCS Eugenio Medea</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Istituto Nazionale di Ricovero e Cura per Anziani</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Institute of Biomedical Technologies-National Research Council, Italy</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of the study will be to understand whether a supplementation of the diet with&#xD;
        an active symbiotic, i.e. characterized by a mix of probiotics and a specially selected fiber&#xD;
        with prebiotic activity combined with a vegetable extract with beneficial activities on&#xD;
        carbohydrate and lipid metabolism, can reduce the relative inflammatory potential and improve&#xD;
        absorption, intestinal motility and bowel habit of patients with various pathological&#xD;
        conditions, such as ALS, ADHD and bronchial asthma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Clinical survey conducted for research and study purposes, multicenter, focusing on ALS&#xD;
        patients, elderly patients with chronic diseases, and pediatric patients with&#xD;
        neurodevelopmental disorders. For each of the diseases treated, patients will be randomized&#xD;
        into the two treatment arms (Study Group, GS; Control Group, GC) according to a block&#xD;
        randomization, with a block size of 4 and an allocation ratio of 1:1. The randomization will&#xD;
        be double-blind.&#xD;
  &#xD;
          -  Study Group or GS: These subjects will be given an active symbiotic preparation&#xD;
             consisting of two sticks of 1500mg each and of different colors.&#xD;
  &#xD;
          -  Control group or GC:These subjects will be given a passive symbiotic preparation again&#xD;
             consisting of two sticks of 1500mg each.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 1, 2021</start_date>
    <completion_date type="Actual">March 31, 2023</completion_date>
    <primary_completion_date type="Actual">October 31, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in levels of Short Chain Fatty Acids (SCFA)</measure>
      <time_frame>Before and After 3 months of intervention</time_frame>
      <description>Evaluation of pre-post treatment variation of the level of specific SCFAs (acetic acid, propionic acid, butyric acid and valeric acid) both within the group of the treated and between the group of treated patients and the placebo group.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in levels of branched chain fatty acids (isobutyrate and isovalerate)</measure>
      <time_frame>Before and After 3 months of intervention</time_frame>
      <description>Evaluation of the pre-post nutritional variation of the level of branched chain fatty acids (isobutyrate and isovalerate) between the group of treated patients and the placebo group</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Conners' Parent Rating Scale-Revised - scale H (ADHD Index)</measure>
      <time_frame>Before and After 3 months of intervention</time_frame>
      <description>The score of subscale H on the Conners' Parent Rating Scale-Revised allows to identify children / adolescents at risk of ADHD.&#xD;
  The score is a T-score with mean 50 and deviation standard 10 in the general population Minimum score = 35 Maximum score = 100&#xD;
  Higher scores correspond to greater severity:&#xD;
  &gt;70 very atypical 66-70 moderately atypical 61-65 slightly atypical 56-60 borderline range&#xD;
  ≤ 55 non problematic</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Conners' Parent Rating Scale-Revised - Scale K (total CGI)</measure>
      <time_frame>Before and After 3 months of intervention</time_frame>
      <description>The score of subscale K on the Conners' Parent Rating Scale-Revised reflects a general problem behavior. A high score indicates a hyperactivity problem, often associated with other problem areas.&#xD;
  The score is a T-score with mean 50 and deviation standard 10 in the general population Minimum score = 35 Maximum score = 100&#xD;
  Higher scores correspond to greater severity:&#xD;
  &gt;70 very atypical 66-70 moderately atypical 61-65 slightly atypical 56-60 borderline range&#xD;
  ≤ 55 non problematic</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Conners' Parent Rating Scale-Revised - Scale B (attention problem)</measure>
      <time_frame>Before and After 3 months of intervention</time_frame>
      <description>Higher scores in the subscale B on the Conners' Parent Rating Scale-Revised are are related to lower learning abilities and difficulties in sustaining prolonged levels of attention.&#xD;
  The score is a T-score with mean 50 and deviation standard 10 in the general population Minimum score = 35 Maximum score = 100&#xD;
  Higher scores correspond to greater severity:&#xD;
  &gt;70 very atypical 66-70 moderately atypical 61-65 slightly atypical 56-60 borderline range&#xD;
  ≤ 55 non problematic</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Conners' Parent Rating Scale-Revised - Scale C ( hyperactivity)</measure>
      <time_frame>Before and After 3 months of intervention</time_frame>
      <description>Higher scores in the subscale C on the Conners' Parent Rating Scale-Revised are indicative of higher levels of restlessness and impulsivity.&#xD;
  The score is a T-score with mean 50 and deviation standard 10 in the general population Minimum score = 35 Maximum score = 100&#xD;
  Higher scores correspond to greater severity:&#xD;
  &gt;70 very atypical 66-70 moderately atypical 61-65 slightly atypical 56-60 borderline range&#xD;
  ≤ 55 non problematic</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Amyotrophic Lateral Sclerosis Functional Rating Scale - revised (ALSFRS-r)</measure>
      <time_frame>Before and After 3 months of intervention</time_frame>
      <description>Functional assessment of disease state. maximum score 4 - minimum score 0; for 12 items. indicates normal condition - 0 corresponds to a degree of major severity. The total score can range from a minimum of 0 to a maximum of 48; a score &lt;29 indicates rapid disease progression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gastrointestinal Symptom Rating Scale (GSRS)</measure>
      <time_frame>Before and After 3 months of intervention</time_frame>
      <description>Represents the main symptoms complained about by the patients. maximum score &quot;Unbearable disturbances&quot; - minimum score &quot;No disturbance&quot;; for 15 items.&#xD;
  The scores follow these directions:&#xD;
  No disturbance Mild disturbances Bearable disturbances Moderate disturbances Somewhat severe disturbances Severe disturbances Unbearable disturbances</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Forced Expiratory Volume - 1st second (FEV1)</measure>
      <time_frame>Before and After 3 months of intervention</time_frame>
      <description>Expired Volume measured after 1 second during pneumotachography exam</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Forced Vital capacity (FVC)</measure>
      <time_frame>Before and After 3 months of intervention</time_frame>
      <description>Inspired maximal volume during pneumotachography exam</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Asthma control test score</measure>
      <time_frame>Before and After 3 months of intervention</time_frame>
      <description>Test containing items related to cough and breathlessness, validated in asthmatic subjects&#xD;
  Test contains five items scored on a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">64</enrollment>
    <condition>Adhd</condition>
    <condition>ALS</condition>
    <condition>Bronchial Asthma</condition>
    <arm_group>
      <arm_group_label>Probiotic + fiber</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>These subjects will be given a passive symbiotic preparation again consisting of two sticks of 1500mg each to be taken once a day:&#xD;
  Purple Sachet - Prebiotic - Composed of 500mg acacia fiber (Fibregum®) with high prebiotic activity and 500mg mai starch. Excipients and flavorings.&#xD;
  White Sachet - Probiotic - 30 Billion bacterial strains Lactobacillus plantarum LP (PBS067- EU Collection DSM 24937), Lactobacillus acidophilus L.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Probiotic + Prebiotic</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>These subjects will be given an active symbiotic preparation consisting of two differently colored sticks of 1500mg each to be taken once a day:&#xD;
  Purple Sachet - Active Prebiotic - 500 mg of Fibregum®, a slow-fermenting prebiotic fiber and 500 mg of standardized extract of pigmented Zea Mays L fruit, rich in anthocyanins and polyphenols. Excipients and flavorings.&#xD;
  White Sachet - Probiotic - 30 Billion Bacterial Strains Lactobacillus plantarum LP (PBS067- EU Collection DSM 24937), Lactobacillus acidophilus LA (PBS066 - EU Collection DSM 24936) and Bifidobacterium animalis subsp. lactis BL (BL050 - Eu Collection DSM 25566).</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Prebiotic fiber</intervention_name>
      <description>Moradyn active prebiotic fiber product</description>
      <arm_group_label>Probiotic + Prebiotic</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Dietary fiber</intervention_name>
      <description>Fibregum non-active fiber product</description>
      <arm_group_label>Probiotic + fiber</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Probiotic</intervention_name>
      <description>Defense Plus probiotic complex</description>
      <arm_group_label>Probiotic + Prebiotic</arm_group_label>
      <arm_group_label>Probiotic + fiber</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Population 1 : ALS&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age at enrollment ≥18 years;&#xD;
  &#xD;
            -  ALS diagnosis defined or probable according to El Escorial criteria (Brooks et al.,&#xD;
               2000);&#xD;
  &#xD;
            -  Respiratory function with FVC% &gt;50%.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects unable to give informed consent to the study;&#xD;
  &#xD;
            -  presence of psychiatric disease or severe cognitive impairment;&#xD;
  &#xD;
            -  presence of tracheotomy; presence of severe pre-existing gastrointestinal disease&#xD;
               (e.g., ulcerative rectocolitis; Crohn's disease).&#xD;
  &#xD;
          Population 2: ADHD&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  children between 6 and 16 years old&#xD;
  &#xD;
            -  children with ADHD, diagnosed with DSM-5 criteria and in accordance with the protocol&#xD;
               shared by the Regional ADHD Reference Centers Lombardy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  presence of intellectual disability (QIT&lt;70),&#xD;
  &#xD;
            -  presence of neurological diseases, epilepsy&#xD;
  &#xD;
            -  presence of genetic syndromes&#xD;
  &#xD;
            -  treatment with drug therapies.&#xD;
  &#xD;
          Co-diagnosis with other psychiatric or neurodevelopmental disorders (i.e. Autism, Anxiety,&#xD;
          Depression etc) will not be considered a criterion of exclusion.&#xD;
  &#xD;
          Population 3: Bronchial Ashtma&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  adults above 18 years of age&#xD;
  &#xD;
            -  diagnosed with Bronchial Ashtma following ERS-ETS criteria&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  life expectancy less than 18 months&#xD;
  &#xD;
            -  active respiratory infections&#xD;
  &#xD;
            -  cognitive disorders that prevent participation to the study (MMS &lt;24)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Scientific Institute IRCCS Eugenio Medea</name>
        <address>
          <city>Bosisio Parini</city>
          <state>LC</state>
          <zip>23842</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Alessia Fumagalli</name>
        <address>
          <city>Casatenovo</city>
          <state>LC</state>
          <zip>23880</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>IBBA-CNR</name>
        <address>
          <city>Milan</city>
          <zip>20133</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Centro Clinico NEMO - Fondazione Serena Onlus, Milano</name>
        <address>
          <city>Milan</city>
          <zip>20162</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Asthma</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06005506
  org study id: NM102_SPATIALS3
  nct id: NCT06005506
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of the study will be to understand whether a supplementation of the diet with
        an active symbiotic, i.e. characterized by a mix of probiotics and a specially selected fiber
        with prebiotic activity combined with a vegetable extract with beneficial activities on
        carbohydrate and lipid metabolism, can reduce the relative inflammatory potential and improve
        absorption, intestinal motility and bowel habit of patients with various pathological
        conditions, such as ALS, ADHD and bronchial asthma.
  Clinical survey conducted for research and study purposes, multicenter, focusing on ALS
        patients, elderly patients with chronic diseases, and pediatric patients with
        neurodevelopmental disorders. For each of the diseases treated, patients will be randomized
        into the two treatment arms (Study Group, GS; Control Group, GC) according to a block
        randomization, with a block size of 4 and an allocation ratio of 1:1. The randomization will
        be double-blind.
  
          -  Study Group or GS: These subjects will be given an active symbiotic preparation
             consisting of two sticks of 1500mg each and of different colors.
  
          -  Control group or GC:These subjects will be given a passive symbiotic preparation again
             consisting of two sticks of 1500mg each.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Investigator)
  measure: Change in levels of Short Chain Fatty Acids (SCFA)
  time frame: Before and After 3 months of intervention
  description: Evaluation of pre-post treatment variation of the level of specific SCFAs (acetic acid, propionic acid, butyric acid and valeric acid) both within the group of the treated and between the group of treated patients and the placebo group.
  measure: Change in levels of branched chain fatty acids (isobutyrate and isovalerate)
  time frame: Before and After 3 months of intervention
  description: Evaluation of the pre-post nutritional variation of the level of branched chain fatty acids (isobutyrate and isovalerate) between the group of treated patients and the placebo group
  measure: Conners' Parent Rating Scale-Revised - scale H (ADHD Index)
  time frame: Before and After 3 months of intervention
  description: The score of subscale H on the Conners' Parent Rating Scale-Revised allows to identify children / adolescents at risk of ADHD.
  The score is a T-score with mean 50 and deviation standard 10 in the general population Minimum score = 35 Maximum score = 100
  Higher scores correspond to greater severity:
  >70 very atypical 66-70 moderately atypical 61-65 slightly atypical 56-60 borderline range
  ≤ 55 non problematic
  measure: Conners' Parent Rating Scale-Revised - Scale K (total CGI)
  time frame: Before and After 3 months of intervention
  description: The score of subscale K on the Conners' Parent Rating Scale-Revised reflects a general problem behavior. A high score indicates a hyperactivity problem, often associated with other problem areas.
  The score is a T-score with mean 50 and deviation standard 10 in the general population Minimum score = 35 Maximum score = 100
  Higher scores correspond to greater severity:
  >70 very atypical 66-70 moderately atypical 61-65 slightly atypical 56-60 borderline range
  ≤ 55 non problematic
  measure: Conners' Parent Rating Scale-Revised - Scale B (attention problem)
  time frame: Before and After 3 months of intervention
  description: Higher scores in the subscale B on the Conners' Parent Rating Scale-Revised are are related to lower learning abilities and difficulties in sustaining prolonged levels of attention.
  The score is a T-score with mean 50 and deviation standard 10 in the general population Minimum score = 35 Maximum score = 100
  Higher scores correspond to greater severity:
  >70 very atypical 66-70 moderately atypical 61-65 slightly atypical 56-60 borderline range
  ≤ 55 non problematic
  measure: Conners' Parent Rating Scale-Revised - Scale C ( hyperactivity)
  time frame: Before and After 3 months of intervention
  description: Higher scores in the subscale C on the Conners' Parent Rating Scale-Revised are indicative of higher levels of restlessness and impulsivity.
  The score is a T-score with mean 50 and deviation standard 10 in the general population Minimum score = 35 Maximum score = 100
  Higher scores correspond to greater severity:
  >70 very atypical 66-70 moderately atypical 61-65 slightly atypical 56-60 borderline range
  ≤ 55 non problematic
  measure: Amyotrophic Lateral Sclerosis Functional Rating Scale - revised (ALSFRS-r)
  time frame: Before and After 3 months of intervention
  description: Functional assessment of disease state. maximum score 4 - minimum score 0; for 12 items. indicates normal condition - 0 corresponds to a degree of major severity. The total score can range from a minimum of 0 to a maximum of 48; a score <29 indicates rapid disease progression.
  measure: Gastrointestinal Symptom Rating Scale (GSRS)
  time frame: Before and After 3 months of intervention
  description: Represents the main symptoms complained about by the patients. maximum score "Unbearable disturbances" - minimum score "No disturbance"; for 15 items.
  The scores follow these directions:
  No disturbance Mild disturbances Bearable disturbances Moderate disturbances Somewhat severe disturbances Severe disturbances Unbearable disturbances
  measure: Forced Expiratory Volume - 1st second (FEV1)
  time frame: Before and After 3 months of intervention
  description: Expired Volume measured after 1 second during pneumotachography exam
  measure: Forced Vital capacity (FVC)
  time frame: Before and After 3 months of intervention
  description: Inspired maximal volume during pneumotachography exam
  measure: Asthma control test score
  time frame: Before and After 3 months of intervention
  description: Test containing items related to cough and breathlessness, validated in asthmatic subjects
  Test contains five items scored on a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled)
  arm group label: Probiotic + fiber
  arm group type: Active Comparator
  description: These subjects will be given a passive symbiotic preparation again consisting of two sticks of 1500mg each to be taken once a day:
  Purple Sachet - Prebiotic - Composed of 500mg acacia fiber (Fibregum®) with high prebiotic activity and 500mg mai starch. Excipients and flavorings.
  White Sachet - Probiotic - 30 Billion bacterial strains Lactobacillus plantarum LP (PBS067- EU Collection DSM 24937), Lactobacillus acidophilus L.
  arm group label: Probiotic + Prebiotic
  arm group type: Experimental
  description: These subjects will be given an active symbiotic preparation consisting of two differently colored sticks of 1500mg each to be taken once a day:
  Purple Sachet - Active Prebiotic - 500 mg of Fibregum®, a slow-fermenting prebiotic fiber and 500 mg of standardized extract of pigmented Zea Mays L fruit, rich in anthocyanins and polyphenols. Excipients and flavorings.
  White Sachet - Probiotic - 30 Billion Bacterial Strains Lactobacillus plantarum LP (PBS067- EU Collection DSM 24937), Lactobacillus acidophilus LA (PBS066 - EU Collection DSM 24936) and Bifidobacterium animalis subsp. lactis BL (BL050 - Eu Collection DSM 25566).
  intervention type: Dietary Supplement
  intervention name: Prebiotic fiber
  description: Moradyn active prebiotic fiber product
  arm group label: Probiotic + Prebiotic
  intervention type: Dietary Supplement
  intervention name: Dietary fiber
  description: Fibregum non-active fiber product
  arm group label: Probiotic + fiber
  intervention type: Dietary Supplement
  intervention name: Probiotic
  description: Defense Plus probiotic complex
  arm group label: Probiotic + Prebiotic
  arm group label: Probiotic + fiber
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  facility: 
  facility: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Asthma