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Fecal Microbiota Transplant for Autism

JD
SH
Overseen BySabine Hazan, MD
Age: Any Age
Sex: Any
Trial Phase: Phase 1
Sponsor: ProgenaBiome
Must be taking: Vancomycin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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?

SH

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

I am getting help for autism at school or in the community.
A reliable parent or caregiver who can report the side effects and communicate effectively with the research team
A reliable parent or caregiver who can report the side effects and communicate effectively with the research team.
See 8 more

Exclusion Criteria

I cannot stop taking my diarrhea medication before the study.
Hepatic values greater than 20
Unable to stop opiate treatment unless on a stable dose including PRN dosing, and no dose increase planned for the duration of the study
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-week treatment with Vancomycin

6 weeks

Fecal Microbiota Transplant

Participants are given fecal microbiota transplant by colonoscopy

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Fecal Microbiota Transplant
Trial Overview The study tests the effect of fecal microbiota transplant from family members in treating social deficits and language delays in ASD patients after a preliminary treatment with Vancomycin for six weeks. It's an open-label trial where everyone knows what treatment is being given.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Autism SubjectsExperimental Treatment1 Intervention

Fecal Microbiota Transplant is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Fecal Microbiota Transplantation for:
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Approved in European Union as Faecal Microbiota Transplantation for:
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Approved in Canada as Fecal Microbiota Transplantation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

ProgenaBiome

Lead Sponsor

Trials
46
Recruited
5,400+

Ventura Clinical Trials

Collaborator

Trials
1
Recruited
30+

Published Research Related to This Trial

Fecal microbiota transplantation (FMT) is primarily used to treat gastrointestinal diseases caused by harmful microorganisms, but it is also being explored for conditions like metabolic syndrome, diabetes, cancer, and Parkinson's disease.
The review discusses the effects of FMT on weight gain, immune response, and various diseases, while also addressing potential side effects that recipients may experience.
Fecal microbiota transplantation in disease therapy.Antushevich, H.[2020]
Faecal microbiota transplantation (FMT) has proven effective for treating recurrent Clostridium difficile infections, with established protocols and donor stool banks in Denmark.
However, FMT is not recommended for routine use in treating inflammatory bowel disease or irritable bowel syndrome due to insufficient clinical trial data supporting its efficacy for these conditions.
[Faecal microbiota transplantation for the treatment of bowel disease].Rode, AA., Chehri, M., Petersen, AM., et al.[2019]
Fecal microbiota transplantation (FMT) is an effective method for modifying the gut microbiome and has shown promise in treating various conditions, including Clostridiodes difficile infection (CDI) and other gastrointestinal and neurological disorders.
While FMT is currently approved for CDI in Taiwan, there is a growing interest in its potential applications for other diseases, particularly in children, where data is still limited.
Current and future applications of fecal microbiota transplantation for children.Chen, CC., Chiu, CH.[2022]

Citations

Effect of fecal microbiota transplantation in children with autism spectrum disorder: A systematic review. [2023]
Fecal microbiota transplantation in disease therapy. [2020]
Fecal microbiota transplantation in children: current concepts. [2020]
[Faecal microbiota transplantation for the treatment of bowel disease]. [2019]
Current and future applications of fecal microbiota transplantation for children. [2022]
Fecal Microbiota Transplantation: Is It Safe? [2021]
Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review. [2022]
Adverse events of fecal microbiota transplantation: a meta-analysis of high-quality studies. [2022]
[Current research progress and thinking of fecal microbiota transplantation for the treatment of gastrointestinal disorders]. [2020]
Transfer of Tumor-Bearing Mice Intestinal Flora Can Ameliorate Cognition in Alzheimer's Disease Mice. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Systematic Review: Adverse Events of Fecal Microbiota Transplantation. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Methods and Reporting Studies Assessing Fecal Microbiota Transplantation: A Systematic Review. [2022]
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