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

Phase 2

Withdrawn

• Conditions: ASD; CP101; SPROUT; Fecal Transplant; Autism; Finch; Fecal Microbiota Transplant; Autism Spectrum Disorder; FMT; Autistic Thinking
• Interventions: Drug: Placebo; Drug: CP101

• Registration Number: NCT03829878
• Lead Sponsor: 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.

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

Study Timeline

• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-02-01
• Study First Posted: 2019-02-04
• Study Start: 2020-05
• Primary Completion: 2020-05
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-05
• Last Update Posted: 2021-04-08
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo for CP101
CP101	CP101	CP101 (Full Spectrum Microbiota) Capsule

Primary Outcome Measures

Name	Time	Method
Childhoood Autism Rating Scales-2 (CARS-2)	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

Name	Time	Method
Gastrointestinal Stool & Symptom Questionnaire for Autism (GSSQA)	55 weeks	17 item assessment evaluating GI symptoms on a scale from "Not at all" to "Almost always".
Aberrant Behavior Checklist-2 (ABC-2)	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).
Gastrointestinal Symptom Rating Scale (GSRS)	55 weeks	Contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one.
Social Responsiveness Scale-2 (SRS-2)	55 weeks	Total Score; Scores for 5 Treatment Subscales; Scores for 2 DSM-5 Compatible Subscales
Parent Global Impressions-III (PGI-III)	55 weeks	19 question assessment evaluating parent observations from "much worse" to "much better".
Autism Diagnostic Interview-Revised (ADI-R)	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.
Reynolds Intellectual Assessment Scales-2-Nonverbal (RIAS-2-NV)	55 weeks	IQ test with 8 sub-categories. Scores from each category summed, then indexed