Trials / Withdrawn
WithdrawnNCT03829878
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Autism Spectrum Disorder and Associated GI Symptoms (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
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Finch Research and Development LLC. · Industry
- Sex
- All
- Age
- 5 Years – 17 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CP101 | Orally administered donor derived full spectrum microbiota |
| DRUG | Placebo | Placebo for CP101 |
Timeline
- Start date
- 2020-05-01
- Primary completion
- 2020-05-01
- Completion
- 2021-12-01
- First posted
- 2019-02-04
- Last updated
- 2021-04-08
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03829878. Inclusion in this directory is not an endorsement.