Could a poop transplant ease autism? small trial aims to find out
NCT ID NCT04630847
First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
This early-phase trial tests whether giving adults with autism a 6-week course of vancomycin followed by a fecal transplant from a close relative can improve social and language problems. Ten participants will be tracked for changes in autism symptoms, quality of life, and gut health. The goal is to see if adjusting gut bacteria can ease core autism challenges.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vancomycin followed by fecal microbiota transplant from a first-degree relative
- What this could lead to
- If it works, this could point toward a way to improve social skills and language in some adults with autism by changing their gut bacteria.
- What could go wrong
- This is a very early, small trial with only 10 people, so results may not apply to everyone. The procedure also carries risks like infection or digestive upset.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2027
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject at least six years of age. 2. Subject has confirmed diagnosis of ASD based on the DSM-V. 3. Subject with ASD whose parents/caregiver/guardian/LAR can complete informed consent process. 4. A reliable parent or caregiver who can report the side effects and communicate effectively with the research team. 5. Comorbid gastrointestinal symptoms 6. Stable medications during the two months prior to enrollment. 7. Currently receiving interventions in the community or school for ASD. 8. 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) 9. 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) Exclusion Criteria: 1. Female subjects who are pregnant, nursing, or intend to become pregnant during the study period. 2. Subjects whose caregivers are unable/unwilling to cooperate with the protocol requirements. 3. Subject will be excluded who are suffering with Rett syndrome and Childhood Disintegrative Disorder. 4. Other serious co-morbid medical disorders affecting brain function and behavior, including uncontrolled seizures. 5. Subjects unable to refrain from taking non-study antibiotics for the period of the study. 6. Subjects diagnosed with cancer, except small localized basal cell carcinoma. 7. Subjects known to abuse alcohol or drugs. 8. Subjects who have undergone gastric bypass or total colectomy, or who are scheduled for these procedures. 9. Infection with HIV. 10. Infection with Hepatitis B or C. 11. Allergy to benzodiazepine. 12. Inability to stop loperamide, diphenoxylatye/atropine, or cholestyramine before the study 13. Unable to stop opiate treatment unless on a stable dose including PRN dosing, and no dose increase planned for the duration of the study 14. 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). 15. Known stool studies positive for ova and/or parasites in 30 days prior to enrollment. (Same as above). 16. Planned travel outside United States during study period. 17. Hypersensitivity to vancomycin 18. Renal insufficiency 19. Colitis
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ProgenaBiome
Ventura, California, 93003, United States
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