<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/NCT03829878</url>
  </required_header>
  <id_info>
    <org_study_id>CP101-ASD-203</org_study_id>
    <nct_id>NCT03829878</nct_id>
  </id_info>
  <brief_title>Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Autism Spectrum Disorder and Associated GI Symptoms (SPROUT)</brief_title>
  <acronym>SPROUT</acronym>
  <official_title>A Randomized Double-Blind Placebo Controlled Cross-Over Study of CP101 (Full-Spectrum Microbiota®) in Children With Autism Spectrum Disorder and Associated Gastrointestinal Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Finch Research and Development LLC.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Finch Research and Development LLC.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adolescent autism spectrum disorder subjects with associated GI symptoms will be randomized&#xD;
      to receive oral dosing of CP101 capsules in Treatment Group I or matching placebo capsules in&#xD;
      Treatment Group II. The purpose of this study is to demonstrate the safety and effectiveness&#xD;
      of CP101 in subjects with ASD and associated GI symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Randomized Double-Blind Placebo Controlled Study of CP101 (Full-Spectrum&#xD;
      Microbiota®) in Children with Autism Spectrum Disorder and Associated Gastrointestinal&#xD;
      Symptoms&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study not started&#xD;
  </why_stopped>
  <start_date type="Anticipated">May 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">May 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Childhoood Autism Rating Scales-2 (CARS-2)</measure>
    <time_frame>24 weeks</time_frame>
    <description>Two 15-item rating scales completed by the clinician (each designed for a different population); and an unscored Parent/Caregiver Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aberrant Behavior Checklist-2 (ABC-2)</measure>
    <time_frame>55 weeks</time_frame>
    <description>Scoring scale range from 1-3 for a 58 question, 5 behavior category assessments. All categories summed for individual total scores (7-48). Individual total scores determine severity (the higher, the more severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Responsiveness Scale-2 (SRS-2)</measure>
    <time_frame>55 weeks</time_frame>
    <description>Total Score; Scores for 5 Treatment Subscales; Scores for 2 DSM-5 Compatible Subscales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent Global Impressions-III (PGI-III)</measure>
    <time_frame>55 weeks</time_frame>
    <description>19 question assessment evaluating parent observations from &quot;much worse&quot; to &quot;much better&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal Symptom Rating Scale (GSRS)</measure>
    <time_frame>55 weeks</time_frame>
    <description>Contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal Stool &amp; Symptom Questionnaire for Autism (GSSQA)</measure>
    <time_frame>55 weeks</time_frame>
    <description>17 item assessment evaluating GI symptoms on a scale from &quot;Not at all&quot; to &quot;Almost always&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reynolds Intellectual Assessment Scales-2-Nonverbal (RIAS-2-NV)</measure>
    <time_frame>55 weeks</time_frame>
    <description>IQ test with 8 sub-categories. Scores from each category summed, then indexed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autism Diagnostic Interview-Revised (ADI-R)</measure>
    <time_frame>55 weeks</time_frame>
    <description>The ADI-R provides a diagnostic algorithm for autism as described in both the ICD-10 and DSM-IV. The instrument focuses on behavior in three main areas: qualities of reciprocal social interaction; communication and language; and restricted and repetitive, stereotyped interests and behaviors.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <condition>Autism</condition>
  <condition>ASD</condition>
  <condition>Autistic Thinking</condition>
  <condition>Autistic Behavior</condition>
  <condition>Finch</condition>
  <condition>FMT</condition>
  <condition>Fecal Microbiota Transplant</condition>
  <condition>CP101</condition>
  <condition>SPROUT</condition>
  <condition>Fecal Transplant</condition>
  <arm_group>
    <arm_group_label>CP101</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CP101 (Full Spectrum Microbiota) Capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo for CP101</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CP101</intervention_name>
    <description>Orally administered donor derived full spectrum microbiota</description>
    <arm_group_label>CP101</arm_group_label>
    <other_name>FSM</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo for CP101</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female ages 5 to 17&#xD;
&#xD;
          -  Diagnosis of ASD by health care provider&#xD;
&#xD;
          -  CARS-2 score ≥35 by the study evaluator&#xD;
&#xD;
          -  1 year history of chronic abnormal bowel function with/without GI symptoms&#xD;
&#xD;
          -  GSRS/Constipation sub-score ≥3.0, or/and GSRS/diarrhea sub-score ≥3.0, during&#xD;
             Screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to ingest intact capsules.&#xD;
&#xD;
          -  Change or anticipated change of prescription medications and/or nutrition supplement&#xD;
             and/or therapy to treat ASD symptoms&#xD;
&#xD;
          -  Prior history, evidence, or diagnosis of inflammatory bowel disease or chronic&#xD;
             autoimmune GI disease&#xD;
&#xD;
          -  Below 5th percentile for weight on Centers for Disease Control and Prevention (CDC)&#xD;
             growth chart based on age&#xD;
&#xD;
          -  History of fecal microbiota transplantation (FMT) for any condition, regardless of&#xD;
             route of administration within 12 months of Screening, or plan to undergo during the&#xD;
             study&#xD;
&#xD;
          -  History of epilepsy or any other seizure (except febrile seizure) disorder.&#xD;
&#xD;
          -  Enrollment in any other investigational drug or device study within 8 weeks prior to&#xD;
             investigational study medication (CP101/placebo) administration or within 5 half-lives&#xD;
             of the last dose of the previous investigational compound, whichever is longer.&#xD;
&#xD;
          -  Major intra-abdominal surgery within the past 60 days prior to Screening (excluding&#xD;
             appendectomy or cholecystectomy) and/or planned invasive surgery/hospitalization&#xD;
             during the study.&#xD;
&#xD;
          -  Use of systemic antibiotics, systemic antiviral, or systemic antifungal (non-topical)&#xD;
             for any condition during 8 weeks prior to Screening, or any anticipated use of above&#xD;
             for any condition (e.g., frequent otitis media requiring antibiotics) before EOT (Week&#xD;
             24).&#xD;
&#xD;
          -  Recent change or anticipated change of non-dietary probiotics.&#xD;
&#xD;
          -  Any clinically significant condition that would jeopardize the safety or rights of the&#xD;
             subject, or would confound the results of the study, in the opinion of the Principal&#xD;
             Investigator.&#xD;
&#xD;
          -  Clinically significant laboratory abnormalities at Screening at the discretion of the&#xD;
             Principal Investigator.&#xD;
&#xD;
          -  Pregnant, breast-feeding, or positive pregnancy test at Screening (for females of&#xD;
             child-bearing potential) or for sexually active subjects (as determined by the&#xD;
             Principal Investigator), who refuses to practice an acceptable form of birth control&#xD;
             for the duration of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>April 5, 2021</last_update_submitted>
  <last_update_submitted_qc>April 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</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>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03829878
org study id: CP101-ASD-203
nct id: NCT03829878
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Adolescent autism spectrum disorder subjects with associated GI symptoms will be randomized
      to receive oral dosing of CP101 capsules in Treatment Group I or matching placebo capsules in
      Treatment Group II. The purpose of this study is to demonstrate the safety and effectiveness
      of CP101 in subjects with ASD and associated GI symptoms.
This is a Randomized Double-Blind Placebo Controlled Study of CP101 (Full-Spectrum
      Microbiota®) in Children with Autism Spectrum Disorder and Associated Gastrointestinal
      Symptoms
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Childhoood Autism Rating Scales-2 (CARS-2)
time frame: 24 weeks
description: Two 15-item rating scales completed by the clinician (each designed for a different population); and an unscored Parent/Caregiver Questionnaire
measure: Aberrant Behavior Checklist-2 (ABC-2)
time frame: 55 weeks
description: Scoring scale range from 1-3 for a 58 question, 5 behavior category assessments. All categories summed for individual total scores (7-48). Individual total scores determine severity (the higher, the more severe).
measure: Social Responsiveness Scale-2 (SRS-2)
time frame: 55 weeks
description: Total Score; Scores for 5 Treatment Subscales; Scores for 2 DSM-5 Compatible Subscales
measure: Parent Global Impressions-III (PGI-III)
time frame: 55 weeks
description: 19 question assessment evaluating parent observations from "much worse" to "much better".
measure: Gastrointestinal Symptom Rating Scale (GSRS)
time frame: 55 weeks
description: Contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one.
measure: Gastrointestinal Stool & Symptom Questionnaire for Autism (GSSQA)
time frame: 55 weeks
description: 17 item assessment evaluating GI symptoms on a scale from "Not at all" to "Almost always".
measure: Reynolds Intellectual Assessment Scales-2-Nonverbal (RIAS-2-NV)
time frame: 55 weeks
description: IQ test with 8 sub-categories. Scores from each category summed, then indexed
measure: Autism Diagnostic Interview-Revised (ADI-R)
time frame: 55 weeks
description: The ADI-R provides a diagnostic algorithm for autism as described in both the ICD-10 and DSM-IV. The instrument focuses on behavior in three main areas: qualities of reciprocal social interaction; communication and language; and restricted and repetitive, stereotyped interests and behaviors.
arm group label: CP101
arm group type: Experimental
description: CP101 (Full Spectrum Microbiota) Capsule
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo for CP101
intervention type: Drug
intervention name: CP101
description: Orally administered donor derived full spectrum microbiota
arm group label: CP101
other name: FSM
intervention type: Drug
intervention name: Placebo
description: Placebo for CP101
arm group label: Placebo
criteria: 
gender: All
minimum age: 5 Years
maximum age: 17 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive
sharing ipd: No