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

NCT03829878 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: CP101-ASD-203
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Aberrant Behavior Checklist-2 (ABC-2)

  55 weeks

• Social Responsiveness Scale-2 (SRS-2)

  55 weeks

• Parent Global Impressions-III (PGI-III)

  55 weeks

• Gastrointestinal Symptom Rating Scale (GSRS)

  55 weeks

• Gastrointestinal Stool & Symptom Questionnaire for Autism (GSSQA)

  55 weeks

Study Arms (2)

CP101

EXPERIMENTAL

CP101 (Full Spectrum Microbiota) Capsule

Drug: CP101

Placebo

PLACEBO COMPARATOR

Placebo for CP101

Drug: Placebo

Interventions

CP101 DRUG

Orally administered donor derived full spectrum microbiota

Also known as: FSM

CP101

Placebo DRUG

Placebo for CP101

Placebo

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or Female ages 5 to 17
• Diagnosis of ASD by health care provider
• CARS-2 score ≥35 by the study evaluator
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Finch Research and Development LLC.: lead

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Child Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 4, 2019
• Study Start: May 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: December 1, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share