Clinical trial NCT03829878: Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Autism Spectrum Disorder and Associated GI Symptoms (SPROUT)
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Autism
ASD
Autistic Thinking
Autistic Behavior
Finch
FMT
Fecal Microbiota Transplant
CP101
SPROUT
Fecal Transplant
Lead sponsor: Finch Research and Development LLC.
Sponsor class: INDUSTRY
First posted: 2019-02-04
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Eligibility 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.

Primary outcomes:
measure: Childhoood Autism Rating Scales-2 (CARS-2)
timeFrame: 24 weeks
Secondary outcomes:
measure: Aberrant Behavior Checklist-2 (ABC-2)
timeFrame: 55 weeks
measure: Social Responsiveness Scale-2 (SRS-2)
timeFrame: 55 weeks
measure: Parent Global Impressions-III (PGI-III)
timeFrame: 55 weeks
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: 55 weeks
measure: Gastrointestinal Stool & Symptom Questionnaire for Autism (GSSQA)
timeFrame: 55 weeks
measure: Reynolds Intellectual Assessment Scales-2-Nonverbal (RIAS-2-NV)
timeFrame: 55 weeks
measure: Autism Diagnostic Interview-Revised (ADI-R)
timeFrame: 55 weeks
Other outcomes:
Locations:
Study officials:
References: