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Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Autism Spectrum Disorder and Associated GI Symptoms (SPROUT) (SPROUT)

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ClinicalTrials.gov Identifier: NCT03829878
Recruitment Status : Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Finch Research and Development LLC.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Autism ASD Autistic Thinking Autistic Behavior Finch FMT Fecal Microbiota Transplant CP101 SPROUT Fecal Transplant Drug: CP101 Drug: Placebo Phase 2

Detailed Description:
This is a Randomized Double-Blind Placebo Controlled Study of CP101 (Full-Spectrum Microbiota®) in Children with Autism Spectrum Disorder and Associated Gastrointestinal Symptoms

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CP101
CP101 (Full Spectrum Microbiota) Capsule
Drug: CP101
Orally administered donor derived full spectrum microbiota
Other Name: FSM

Placebo Comparator: Placebo
Placebo for CP101
Drug: Placebo
Placebo for CP101




Primary Outcome Measures :
  1. Childhoood Autism Rating Scales-2 (CARS-2) [ Time Frame: 24 weeks ]
    Two 15-item rating scales completed by the clinician (each designed for a different population); and an unscored Parent/Caregiver Questionnaire


Secondary Outcome Measures :
  1. Aberrant Behavior Checklist-2 (ABC-2) [ Time Frame: 55 weeks ]
    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).

  2. Social Responsiveness Scale-2 (SRS-2) [ Time Frame: 55 weeks ]
    Total Score; Scores for 5 Treatment Subscales; Scores for 2 DSM-5 Compatible Subscales

  3. Parent Global Impressions-III (PGI-III) [ Time Frame: 55 weeks ]
    19 question assessment evaluating parent observations from "much worse" to "much better".

  4. Gastrointestinal Symptom Rating Scale (GSRS) [ Time Frame: 55 weeks ]
    Contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one.

  5. Gastrointestinal Stool & Symptom Questionnaire for Autism (GSSQA) [ Time Frame: 55 weeks ]
    17 item assessment evaluating GI symptoms on a scale from "Not at all" to "Almost always".

  6. Reynolds Intellectual Assessment Scales-2-Nonverbal (RIAS-2-NV) [ Time Frame: 55 weeks ]
    IQ test with 8 sub-categories. Scores from each category summed, then indexed

  7. Autism Diagnostic Interview-Revised (ADI-R) [ Time Frame: 55 weeks ]
    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.



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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female ages 5 to 17
  • Diagnosis of ASD by health care provider
  • CARS-2 score ≥35 by the study evaluator
  • 1 year history of chronic abnormal bowel function with/without GI symptoms
  • GSRS/Constipation sub-score ≥3.0, or/and GSRS/diarrhea sub-score ≥3.0, during Screening

Exclusion Criteria:

  • Inability to ingest intact capsules.
  • Change or anticipated change of prescription medications and/or nutrition supplement and/or therapy to treat ASD symptoms
  • Prior history, evidence, or diagnosis of inflammatory bowel disease or chronic autoimmune GI disease
  • Below 5th percentile for weight on Centers for Disease Control and Prevention (CDC) growth chart based on age
  • History of fecal microbiota transplantation (FMT) for any condition, regardless of route of administration within 12 months of Screening, or plan to undergo during the study
  • History of epilepsy or any other seizure (except febrile seizure) disorder.
  • Enrollment in any other investigational drug or device study within 8 weeks prior to investigational study medication (CP101/placebo) administration or within 5 half-lives of the last dose of the previous investigational compound, whichever is longer.
  • Major intra-abdominal surgery within the past 60 days prior to Screening (excluding appendectomy or cholecystectomy) and/or planned invasive surgery/hospitalization during the study.
  • Use of systemic antibiotics, systemic antiviral, or systemic antifungal (non-topical) for any condition during 8 weeks prior to Screening, or any anticipated use of above for any condition (e.g., frequent otitis media requiring antibiotics) before EOT (Week 24).
  • Recent change or anticipated change of non-dietary probiotics.
  • Any clinically significant condition that would jeopardize the safety or rights of the subject, or would confound the results of the study, in the opinion of the Principal Investigator.
  • Clinically significant laboratory abnormalities at Screening at the discretion of the Principal Investigator.
  • Pregnant, breast-feeding, or positive pregnancy test at Screening (for females of child-bearing potential) or for sexually active subjects (as determined by the Principal Investigator), who refuses to practice an acceptable form of birth control for the duration of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829878


Contacts
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Contact: Ulrich Thienel, MD 857-308-9001 sproutstudy@finchtherapeutics.com
Contact: Tara Lambert 857-308-9001 tlambert@finchtherapeutics.com

Sponsors and Collaborators
Finch Research and Development LLC.

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Responsible Party: Finch Research and Development LLC.
ClinicalTrials.gov Identifier: NCT03829878     History of Changes
Other Study ID Numbers: CP101-ASD-203
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders