AutismPhase 1NCT04630847
Familial Fecal Microbiota Transplant for the Treatment of Subjects With Autism Spectrum Disorders
A Phase 1 study testing Fecal Microbiota Transplant in people with Autism and Autism Spectrum Disorder, run by ProgenaBiome at 1 site in United States.
Trial summary
This is an open-label clinical trial to evaluate the benefits of familial fecal microbiota transplant following a 6-week treatment with Vancomycin in adult subjects with ASD for treatment of social deficits and language delays. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Fecal Microbiota Transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2027to Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject at least six years of age.
- Subject has confirmed diagnosis of ASD based on the DSM-V.
- Subject with ASD whose parents/caregiver/guardian/LAR can complete informed consent process.
- A reliable parent or caregiver who can report the side effects and communicate effectively with the research team.
- Comorbid gastrointestinal symptoms
- Stable medications during the two months prior to enrollment.
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- Currently receiving interventions in the community or school for ASD.
- If female and of childbearing potential, must be willing to utilize at least one highly effective method of birth control for the duration of the study. This includes oral birth control pills, contraceptive implants, and intra-uterine devices. Diaphragms and condoms are not considered highly effective. Subjects not of reproductive potential will be exempt (e.g., post-menopausal, surgically sterilized)
- If male, and partner is of childbearing potential, must be willing to utilize at least one highly effective method of birth control for the duration of the study. This includes oral birth control pills, contraceptive implants, and intra-uterine devices Diaphragms and condoms are not considered highly effective. Subjects not of reproductive potential will be exempt (surgically sterilized)
Who cannot join
- Female subjects who are pregnant, nursing, or intend to become pregnant during the study period.
- Subjects whose caregivers are unable/unwilling to cooperate with the protocol requirements.
- Subject will be excluded who are suffering with Rett syndrome and Childhood Disintegrative Disorder.
- Other serious co-morbid medical disorders affecting brain function and behavior, including uncontrolled seizures.
- Subjects unable to refrain from taking non-study antibiotics for the period of the study.
- Subjects diagnosed with cancer, except small localized basal cell carcinoma.
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- Subjects known to abuse alcohol or drugs.
- Subjects who have undergone gastric bypass or total colectomy, or who are scheduled for these procedures.
- Infection with HIV.
- Infection with Hepatitis B or C.
- Allergy to benzodiazepine.
- Inability to stop loperamide, diphenoxylatye/atropine, or cholestyramine before the study
- Unable to stop opiate treatment unless on a stable dose including PRN dosing, and no dose increase planned for the duration of the study
- Known positive stool cultures for enteropathogens including, but not limited to Shigella, Salmonella, and Campylobacter within 30 days before enrollment. (These infection agents should be treated in advance of participation in this FMT study because they affect the good flora).
- Known stool studies positive for ova and/or parasites in 30 days prior to enrollment. (Same as above).
- Planned travel outside United States during study period.
- Hypersensitivity to vancomycin
- Renal insufficiency
- Colitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
ProgenaBiome
Ventura, California, 93003
Sabine Hazan, MD, 805-339-0549, drsabinehazan@progenabiome.com
Jordan Daniels, MS, 805-339-0549, jordan@progenabiome.com
About this study
Official title: An Open-Label Phase I Clinical Trial of Vancomycin Followed by Familial Fecal Microbiota Transplant in Adult Subjects With Autism Spectrum Disorder (ASD)
This is an open-label clinical trial to evaluate the benefits of familial fecal microbiota transplant following a 6-week treatment with Vancomycin in adult subjects with ASD for treatment of social deficits and language delays.
Read the detailed description
This is an open-label clinical trial to evaluate the benefits of familial fecal microbiota transplant following a 6-week treatment with Vancomycin in adult subjects with ASD for treatment of social deficits and language delays. Participants are given FMT by colonoscopy
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- Fecal Microbiota Transplant
- Keywords
- microbiome, dysbiosis, FMT, fecal transpant, fecal microbiota transplant
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantBiological
FMT utilizing stool from first degree relatives
| Study group | Role | What they receive |
|---|---|---|
| Autism Subjects | Experimental | These subjects will be administered fecal microbiota transplant by colonoscopy Receives: Biological: Fecal Microbiota Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
ATEC
Number of participants with changes in the Autism Treatment Evaluation Checklist scores
Measured: 52 Weeks
QoLA
Number of participants with changes in Quality of Life Autism scores
Measured: 52 Weeks
CARS-2
Number of participants with changes in Childhood Autism Rating Scale 2 scores
Measured: 52 Weeks
SRS-2
Number of patients with changes in SRS-2 scores
Measured: 52 weeks
Behavioral changes
Changes in reported incidence of disturbances in non-core aspects of behavior or function
Measured: 52 weeks
GSRS
Number of patients with reported changes in GSRS measure of GI disturbances
Measured: 52 weeks
abbrvCDAI
Number of patients with changes in abbrevCDAI scores
Measured: 52 weeks
HSPP
Number of subjects with changes in quality of life metric HSPP
Measured: 52 weeks
Secondary outcomes (2)
Shannon Diversity Index
Changes in Shannon Diversity index compared between pre and post FMT scores
Measured: 52 Weeks
Microbiome changes
Number of subjects with changes to microbiome relative abundance and composition
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study startMay 2027 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProgenaBiome
- Sponsor type
- University, hospital or other
- Collaborators
- Ventura Clinical Trials, Microbiome Research Foundation
- Responsible party
- Sponsor
- Investigators
- Sabine Hazan, MD, Study director, ProgenaBiome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630847
- Sponsor's protocol ID
- VCT-1
- Status last verified
- Sep 2026
- First submitted
- 11 Nov 2020
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: HIPAA
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase I Clinical Trial of Vancomycin Followed by Familial Fecal Microbiota Transplant in Adult Subjects With Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT04630847
- Acronym / sponsor ID
- VCT-1
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- microbiome, dysbiosis, FMT, fecal transpant, fecal microbiota transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- ProgenaBiomeUniversity, hospital or other
- Collaborators
- Ventura Clinical Trials, Microbiome Research Foundation
- Study start
- May 2027 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 16 Nov 2020 (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.
This is an open-label clinical trial to evaluate the benefits of familial fecal microbiota transplant following a 6-week treatment with Vancomycin in adult subjects with ASD for treatment of social deficits and language delays.
Detailed description
This is an open-label clinical trial to evaluate the benefits of familial fecal microbiota transplant following a 6-week treatment with Vancomycin in adult subjects with ASD for treatment of social deficits and language delays. Participants are given FMT by colonoscopy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autism Subjects | Experimental | Biological: Fecal Microbiota TransplantThese subjects will be administered fecal microbiota transplant by colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject at least six years of age.
- Subject has confirmed diagnosis of ASD based on the DSM-V.
- Subject with ASD whose parents/caregiver/guardian/LAR can complete informed consent process.
- A reliable parent or caregiver who can report the side effects and communicate effectively with the research team.
- Comorbid gastrointestinal symptoms
Key exclusion criteria (19 listed)
- Female subjects who are pregnant, nursing, or intend to become pregnant during the study period.
- Subjects whose caregivers are unable/unwilling to cooperate with the protocol requirements.
- Subject will be excluded who are suffering with Rett syndrome and Childhood Disintegrative Disorder.
- Other serious co-morbid medical disorders affecting brain function and behavior, including uncontrolled seizures.
- Subjects unable to refrain from taking non-study antibiotics for the period of 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 |
|---|---|---|
| Fecal Microbiota TransplantFMT utilizing stool from first degree relatives | Biological | Autism Subjects |
Primary outcome
ATEC
Time frame: 52 Weeks
Number of participants with changes in the Autism Treatment Evaluation Checklist scores
QoLA
Time frame: 52 Weeks
Number of participants with changes in Quality of Life Autism scores
CARS-2
Time frame: 52 Weeks
Number of participants with changes in Childhood Autism Rating Scale 2 scores
SRS-2
Time frame: 52 weeks
Number of patients with changes in SRS-2 scores
Behavioral changes
Time frame: 52 weeks
Changes in reported incidence of disturbances in non-core aspects of behavior or function
GSRS
Time frame: 52 weeks
Number of patients with reported changes in GSRS measure of GI disturbances
abbrvCDAI
Time frame: 52 weeks
Number of patients with changes in abbrevCDAI scores
HSPP
Time frame: 52 weeks
Number of subjects with changes in quality of life metric HSPP
2 secondary outcomes
Shannon Diversity Index
Time frame: 52 Weeks
Microbiome changes
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No. HIPAA
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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.
Sabine Hazan, MD study director
ProgenaBiome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fecal Microbiota Transplant in people with Autism and Autism Spectrum Disorder, run by ProgenaBiome at 1 site in United States.
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 9 inclusion and 19 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: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Hazan, MD (18053390549, drhazan@progenabiome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ATEC (time frame: 52 Weeks). The study lists 8 primary outcomes in all. 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 18 Sep 2026.