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

NCT ID: NCT03829878

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-31
• Study Completion Date: 2021-12-31

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

Conditions

Autism Spectrum Disorder; Autism; ASD; Autistic Thinking; Autistic Behavior; Finch; FMT; Fecal Microbiota Transplant; CP101; SPROUT; Fecal Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CP101

CP101 (Full Spectrum Microbiota) Capsule

Group Type: EXPERIMENTAL

CP101

Intervention Type: DRUG

Orally administered donor derived full spectrum microbiota

Placebo

Placebo for CP101

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo for CP101

Interventions

CP101

Orally administered donor derived full spectrum microbiota

Intervention Type: DRUG

Placebo

Placebo for CP101

Intervention Type: DRUG

Other Intervention Names

FSM

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Finch Research and Development LLC.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CP101-ASD-203

Identifier Type: -

Identifier Source: org_study_id