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

A Randomized Double-Blind Placebo Controlled Cross-Over Study of CP101 (Full-Spectrum Microbiota®) in Children With Autism Spectrum Disorder and Associated Gastrointestinal Symptoms

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.

Study Overview

• Status: Withdrawn
• Conditions: Autism Spectrum Disorder; Autism; ASD; FMT; Fecal Transplant; Autistic Thinking; Autistic Behavior; Fecal Microbiota Transplant; Finch; CP101; SPROUT
• Intervention / Treatment: Drug: CP101; Drug: Placebo

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 Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CP101; CP101 (Full Spectrum Microbiota) Capsule	Drug: CP101; Orally administered donor derived full spectrum microbiota; Other Names: FSM
Placebo Comparator: Placebo; Placebo for CP101	Drug: Placebo; Placebo for CP101

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Finch Research and Development LLC.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: CP101-ASD-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No