Autism Spectrum DisorderPhase 2SPROUTNCT03829878
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Autism Spectrum Disorder and Associated GI Symptoms (SPROUT)
A Phase 2 study testing CP101 in people with Autism Spectrum Disorder and Autism, run by Finch Research and Development LLC..
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder, Autism, ASD
- What is being tested?
- CP101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2020to Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
About this study
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
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.
Read the 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
- Being tested
- CP101, Placebo
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP101Drug
Also called FSM
Orally administered donor derived full spectrum microbiota
PlaceboDrug
Placebo for CP101
| Study group | Role | What they receive |
|---|---|---|
| CP101 | Experimental | CP101 (Full Spectrum Microbiota) Capsule Receives: Drug: CP101 |
| Placebo | Placebo comparator | Placebo for CP101 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Secondary outcomes (7)
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).
Measured: 55 weeks
Social Responsiveness Scale-2 (SRS-2)
Total Score; Scores for 5 Treatment Subscales; Scores for 2 DSM-5 Compatible Subscales
Measured: 55 weeks
Parent Global Impressions-III (PGI-III)
19 question assessment evaluating parent observations from "much worse" to "much better".
Measured: 55 weeks
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.
Measured: 55 weeks
Gastrointestinal Stool & Symptom Questionnaire for Autism (GSSQA)
17 item assessment evaluating GI symptoms on a scale from "Not at all" to "Almost always".
Measured: 55 weeks
Reynolds Intellectual Assessment Scales-2-Nonverbal (RIAS-2-NV)
IQ test with 8 sub-categories. Scores from each category summed, then indexed
Measured: 55 weeks
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.
Measured: 55 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study startMay 2020 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Study not started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finch Research and Development LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829878
- Sponsor's protocol ID
- CP101-ASD-203
- Acronym
- SPROUT
- Status last verified
- Apr 2021
- First submitted
- 28 Jan 2019
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03829878
- Acronym / sponsor ID
- SPROUT / CP101-ASD-203
- Conditions
- Autism Spectrum Disorder, Autism, ASD, Autistic Thinking, Autistic Behavior, Finch
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Finch Research and Development LLC.Industry (pharma, biotech, devices)
- Study start
- May 2020 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CP101 | Experimental | Drug: CP101CP101 (Full Spectrum Microbiota) Capsule |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for CP101 |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP101Also: FSMOrally administered donor derived full spectrum microbiota | Drug | CP101 |
| PlaceboPlacebo for CP101 | Drug | Placebo |
Primary outcome
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
7 secondary outcomes
Aberrant Behavior Checklist-2 (ABC-2)
Time frame: 55 weeks
Social Responsiveness Scale-2 (SRS-2)
Time frame: 55 weeks
Parent Global Impressions-III (PGI-III)
Time frame: 55 weeks
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: 55 weeks
Gastrointestinal Stool & Symptom Questionnaire for Autism (GSSQA)
Time frame: 55 weeks
Reynolds Intellectual Assessment Scales-2-Nonverbal (RIAS-2-NV)
Time frame: 55 weeks
Autism Diagnostic Interview-Revised (ADI-R)
Time frame: 55 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP101 in people with Autism Spectrum Disorder and Autism, run by Finch Research and Development LLC..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childhoood Autism Rating Scales-2 (CARS-2) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.