Autism Spectrum Disorder Clinical Trial
— SPROUTOfficial title:
A Randomized Double-Blind Placebo Controlled Cross-Over Study of CP101 (Full-Spectrum Microbiota®) in Children With Autism Spectrum Disorder and Associated Gastrointestinal Symptoms
Verified date | April 2021 |
Source | Finch Research and Development LLC. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2021 |
Est. primary completion date | May 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 17 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Finch Research and Development LLC. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Social Responsiveness Scale-2 (SRS-2) | Total Score; Scores for 5 Treatment Subscales; Scores for 2 DSM-5 Compatible Subscales | 55 weeks | |
Secondary | Parent Global Impressions-III (PGI-III) | 19 question assessment evaluating parent observations from "much worse" to "much better". | 55 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Reynolds Intellectual Assessment Scales-2-Nonverbal (RIAS-2-NV) | IQ test with 8 sub-categories. Scores from each category summed, then indexed | 55 weeks | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05207956 -
App for Strengthening Services In Specialized Therapeutic Support
|
N/A | |
Completed |
NCT03286621 -
Development of Eye-tracking Based Markers for Autism in Young Children
|
||
Completed |
NCT02608333 -
Efficiency of Early Intervention for Autism Spectrum Disorder
|
N/A | |
Recruiting |
NCT05935722 -
Evaluation of a Home-based Parenting Support Program: Parenting Young Children
|
N/A | |
Active, not recruiting |
NCT06259539 -
A YouTube Curriculum for Children With Autism and Obesity
|
N/A | |
Active, not recruiting |
NCT06303791 -
Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders
|
N/A | |
Enrolling by invitation |
NCT05017779 -
A Hybrid Effectiveness-implementation Trial of a High School-based Executive Function Treatment for Autistic Youth
|
N/A | |
Completed |
NCT04772898 -
Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder
|
N/A | |
Recruiting |
NCT04987541 -
The Therapeutic Effect of TBS Stimulation on Emotion Regulation in Autism Spectrum Disorder
|
N/A | |
Completed |
NCT04308915 -
Mobile-based Games for Cognitive Training in Children With Neurodevelopmental Disorders
|
N/A | |
Completed |
NCT06038435 -
The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder
|
N/A | |
Terminated |
NCT04049981 -
Investigation of Mechanisms of Action in Superpower Glass
|
Phase 1/Phase 2 | |
Completed |
NCT03693313 -
The Effect of CrossFit Kids on Social Skills in Children With Autism Spectrum Disorder (CrossFit KAMP)
|
N/A | |
Recruiting |
NCT04107064 -
Achieving Steady Work Among Adults With Autism Through Specialized Employment Program
|
N/A | |
Recruiting |
NCT03812068 -
Parent-mediated Developmental Behavioral Intervention
|
N/A | |
Completed |
NCT03206996 -
Exposure Therapy for Auditory Sensitivity in Autism
|
N/A | |
Completed |
NCT02299700 -
Study to Evaluate the Janssen Autism Knowledge Engine in Children and Adults With Autism Spectrum Disorder
|
N/A | |
Completed |
NCT03422016 -
Electroretinogram in Autistic Spectrum Disorders
|
||
Active, not recruiting |
NCT03548779 -
North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2
|
N/A | |
Recruiting |
NCT05114538 -
Improving the Part C Early Intervention Service Delivery System for Children With ASD
|
N/A |