Autism Spectrum DisorderNCT04878718
Vancomycin and Fecal Microbiota Transplant in a Single Patient With Autism Spectrum Disorder
A study testing Fecal Microbiota Transplant; Vancomycin in people with Autism Spectrum Disorder and Autism, run by ProgenaBiome at 1 site in United States.
Trial summary
Single patient with ASD will be treated with Vancomycin followed by FMT. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Autism Spectrum Disorder, Autism
- What is being tested?
- Fecal Microbiota Transplant; Vancomycin
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 2 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Autism Spectrum Disorder
- Parent or Legally Authorized Representative willing and able to provide informed consent
- A reliable caregiver who can report side effects and communicate effectively with the research team
- Stable medications in the two months prior to enrollment
- Currently receiving interventions in the community/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 condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. 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 condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. 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 behaviour, 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, diphenoxylate/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.
- Known stool studies positive for ova and/or parasites in 30 days prior to enrollment.
- Planned travel outside United States during study period.
- Hypersensitivity to vancomycin
- Renal insufficiency
- Colitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vancomycin and Fecal Microbiota Transplant in a Single Patient for the Treatment of Autism Spectrum Disorder
Single patient with ASD will be treated with Vancomycin followed by FMT.
Read the detailed description
A single patient with profound ASD will be treated with Vancomycin. This will be followed by fecal microbiota transplant. The patient will be followed for one year.
- Conditions
- Autism Spectrum Disorder, Autism
- Being tested
- Fecal Microbiota Transplant; Vancomycin
- Keywords
- Fecal Transplant
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplant; VancomycinBiological
Also called FMT, vancomycin
Subject will be treated with vancomycin followed by fecal microbiota transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
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
- Expanded access
Sponsor and investigators
- Lead sponsor
- ProgenaBiome
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Hazan, MD, Study director, ProgenaBiome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878718
- Sponsor's protocol ID
- 19343
- Status last verified
- Jun 2025
- First submitted
- 28 Apr 2021
- Last updated
- 8 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vancomycin and Fecal Microbiota Transplant in a Single Patient for the Treatment of Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04878718
- Acronym / sponsor ID
- 19343
- Conditions
- Autism Spectrum Disorder, Autism
- Keywords
- Fecal Transplant
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- ProgenaBiomeUniversity, hospital or other
- First posted
- 7 May 2021 (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.
Single patient with ASD will be treated with Vancomycin followed by FMT.
Detailed description
A single patient with profound ASD will be treated with Vancomycin. This will be followed by fecal microbiota transplant. The patient will be followed for one year.
Study design
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of Autism Spectrum Disorder
- Parent or Legally Authorized Representative willing and able to provide informed consent
- A reliable caregiver who can report side effects and communicate effectively with the research team
- Stable medications in the two months prior to enrollment
- Currently receiving interventions in the community/school for ASD
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 behaviour, 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 Transplant; VancomycinAlso: FMT, vancomycinSubject will be treated with vancomycin followed by fecal microbiota transplant | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
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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.
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 study testing Fecal Microbiota Transplant; Vancomycin in people with Autism Spectrum Disorder and Autism, 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 7 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: status not confirmed, as of the sponsor's last update on 8 Jun 2025. 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.
Are results available for this study?
Results are not available in the source record.
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.
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 Jun 2025.