Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Autism Spectrum Disorder and Associated GI Symptoms (SPROUT) (SPROUT)
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|ClinicalTrials.gov Identifier: NCT03829878|
Recruitment Status : Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder Autism ASD Autistic Thinking Autistic Behavior Finch FMT Fecal Microbiota Transplant CP101 SPROUT Fecal Transplant||Drug: CP101 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||April 2021|
CP101 (Full Spectrum Microbiota) Capsule
Orally administered donor derived full spectrum microbiota
Other Name: FSM
Placebo Comparator: Placebo
Placebo for CP101
Placebo for CP101
- Childhoood Autism Rating Scales-2 (CARS-2) [ Time Frame: 24 weeks ]Two 15-item rating scales completed by the clinician (each designed for a different population); and an unscored Parent/Caregiver Questionnaire
- Aberrant Behavior Checklist-2 (ABC-2) [ Time Frame: 55 weeks ]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).
- Social Responsiveness Scale-2 (SRS-2) [ Time Frame: 55 weeks ]Total Score; Scores for 5 Treatment Subscales; Scores for 2 DSM-5 Compatible Subscales
- Parent Global Impressions-III (PGI-III) [ Time Frame: 55 weeks ]19 question assessment evaluating parent observations from "much worse" to "much better".
- Gastrointestinal Symptom Rating Scale (GSRS) [ Time Frame: 55 weeks ]Contains 15 items, uses a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one.
- Gastrointestinal Stool & Symptom Questionnaire for Autism (GSSQA) [ Time Frame: 55 weeks ]17 item assessment evaluating GI symptoms on a scale from "Not at all" to "Almost always".
- Reynolds Intellectual Assessment Scales-2-Nonverbal (RIAS-2-NV) [ Time Frame: 55 weeks ]IQ test with 8 sub-categories. Scores from each category summed, then indexed
- Autism Diagnostic Interview-Revised (ADI-R) [ Time Frame: 55 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829878
|Contact: Ulrich Thienel, MDfirstname.lastname@example.org|
|Contact: Tara Lambertemail@example.com|