Fecal Microbiota Transplant for Autism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a treatment for people with Autism Spectrum Disorder that involves taking an antibiotic for a period of time followed by a procedure involving gut health from a family member. The goal is to improve social skills and language by enhancing gut health.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you must refrain from taking non-study antibiotics and certain medications like loperamide, diphenoxylate/atropine, or cholestyramine. If you are on opiate treatment, you must be on a stable dose with no planned increase during the study.
Is Fecal Microbiota Transplantation (FMT) safe for humans?
FMT is generally considered safe and well-tolerated, especially for treating recurrent Clostridioides difficile infections. Most short-term risks are mild and related to delivery methods, but long-term side effects are not well-established. Serious adverse events have been linked to inadequate screening for multi-drug resistant organisms in donor stool.12345
How is fecal microbiota transplant (FMT) different from other treatments for autism?
Fecal microbiota transplant (FMT) is unique because it involves transferring healthy gut bacteria from a donor to a patient to rebalance the gut microbiome, which may improve behavioral symptoms in children with autism. Unlike traditional treatments that might focus on behavioral therapy or medication, FMT targets the gut-brain connection, offering a novel approach to managing autism spectrum disorder.36789
What data supports the effectiveness of the treatment Fecal Microbiota Transplant for Autism?
Research suggests that Fecal Microbiota Transplant (FMT) may help improve behavioral symptoms in children with autism by rebalancing the gut microbiome. FMT has also been used effectively for other conditions like recurrent Clostridium difficile infection and shows potential for treating various diseases, including metabolic and neurological disorders.38101112
Who Is on the Research Team?
Sabine Hazan, MD
Principal Investigator
ProgenaBiome
Are You a Good Fit for This Trial?
This trial is for individuals at least two years old with a confirmed diagnosis of Autism Spectrum Disorder (ASD) who are stable on medications and receiving community or school interventions. Participants need a reliable caregiver to report side effects. Males with partners of childbearing potential must use birth control. Exclusions include pregnancy, nursing, unwilling caregivers, certain medical conditions like uncontrolled seizures, substance abuse, major surgeries like gastric bypass or total colectomy planned or done.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a 6-week treatment with Vancomycin
Fecal Microbiota Transplant
Participants are given fecal microbiota transplant by colonoscopy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Fecal Microbiota Transplant
Fecal Microbiota Transplant is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
ProgenaBiome
Lead Sponsor
Ventura Clinical Trials
Collaborator