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

• Status: Withdrawn
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Finch Research and Development LLC.

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.