Fecal Microbiota Transplant for Parkinson's Disease

Overseen By Alex Lopez

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ProgenaBiome

Disqualifiers: Non-PD individuals

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a fecal microbiota transplant (FMT) can improve symptoms in people with Parkinson's disease. Researchers believe that gut issues may significantly contribute to Parkinson’s disease, and FMT could address this. Participants will receive FMT following a 10-day course of the antibiotic vancomycin. The trial seeks individuals diagnosed with Parkinson's disease. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that Fecal Microbiota Transplant is likely to be safe for humans?

Research shows that fecal microbiota transplants (FMT) are generally safe. Previous studies have used FMT to treat various health issues with positive results. Most patients tolerated the procedure well, and serious side effects were uncommon. Mild side effects included stomach discomfort and diarrhea.

The FDA has approved FMT for treating certain infections, indicating a level of safety. However, since this trial is in the early stages, it focuses primarily on ensuring safety for people with Parkinson's disease. While early results are promising, the treatment is still under careful study for this new use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's?

Unlike standard Parkinson's treatments, which typically focus on managing symptoms with medications like Levodopa or dopamine agonists, Fecal Microbiota Transplant (FMT) offers a novel approach by targeting the gut microbiome. This treatment is unique because it involves transplanting beneficial bacteria from a healthy donor's stool to the patient, potentially rebalancing gut flora and influencing neurological health. Researchers are excited about FMT because it taps into the gut-brain axis, a cutting-edge area of study, and could offer benefits beyond symptom management, potentially addressing underlying factors of the disease.

What evidence suggests that Fecal Microbiota Transplant might be an effective treatment for Parkinson's Disease?

Studies have shown that fecal microbiota transplantation (FMT) can restore the balance of bacteria in the gut. This is important because gut health might influence Parkinson's disease symptoms. Early findings suggest FMT could improve quality of life and lessen symptoms for people with Parkinson's. Research has demonstrated FMT's effectiveness in other conditions by rebalancing gut bacteria, supporting the idea that it might help with Parkinson's as well. Although interest is growing, more studies are needed to confirm its effectiveness specifically for Parkinson's disease. Participants in this trial will receive FMT after a 10-day treatment with Vancomycin to evaluate its safety in adult subjects with Parkinson's disease. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This clinical trial is open to individuals who have been diagnosed with Parkinson's Disease (PD). It specifically excludes anyone who does not have PD.

Inclusion Criteria

I have been diagnosed with Parkinson's disease.

Exclusion Criteria

My condition is not worsening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

2 visits (in-person)

Vancomycin Treatment

Participants receive a 10-day treatment with Vancomycin

1.5 weeks

1 visit (in-person)

Fecal Microbiota Transplant

Participants undergo fecal microbiota transplant procedure by colonoscopy

1 day

1 visit (in-person)

Post-FMT Assessment

Participants are assessed post-FMT with daily phone calls for a week and weekly phone calls thereafter

6.5 months

7 visits (in-person), weekly phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fecal Microbiota Transplant

Trial Overview The trial is testing whether Fecal Microbiota Transplant (FMT) can improve the quality of life and reduce symptom severity in people with Parkinson's Disease, based on the theory that gut bacteria imbalances affect PD.

How Is the Trial Designed?

Group I: PD patients Experimental Treatment 1 Intervention

This is an open-label clinical trial to evaluate the Safety of fecal microbiota transplant following a 10 day treatment with Vancomycin in adult subjects with Parkinson's disease.

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:

• Recurrent and refractory Clostridioides difficile infection

Approved in European Union as Faecal Microbiota Transplantation for:

• Recurrent and refractory Clostridioides difficile infection

Approved in Canada as Fecal Microbiota Transplantation for:

• Recurrent and refractory Clostridioides difficile infection

Who Is Running the Clinical Trial?

ProgenaBiome

Lead Sponsor

Trials

46

Recruited

5,400+

Published Research Related to This Trial

A 71-year-old male patient with Parkinson's disease and severe constipation experienced significant relief after undergoing fecal microbiota transplantation (FMT), achieving normal bowel movements within 5 minutes post-procedure.

The patient's Parkinson's symptoms, particularly tremors, improved notably within a week of FMT, suggesting that gut microbiota reconstruction may offer therapeutic benefits for Parkinson's patients with gastrointestinal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation to treat Parkinson's disease with constipation: A case report. Huang, H., Xu, H., Luo, Q., et al.[2022]

Fecal microbiota transplantation (FMT) is a safe and effective treatment for Clostridioides difficile infection, and emerging evidence suggests it may also benefit various other conditions like irritable bowel syndrome and inflammatory bowel disease.

The review highlights the expanding applications of FMT beyond gastrointestinal issues, including its potential roles in treating liver disorders, metabolic disorders, and even neurological conditions, while also discussing regulatory aspects and future directions for FMT research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation in gastrointestinal and extraintestinal disorders. Ianiro, G., Segal, JP., Mullish, BH., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation in disease therapy. Antushevich, H.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12269262/

Efficacy and safety of fecal microbiota transplantation in the ... The search terms used were: ("Fecal Microbiota Transplant" OR "Intestinal Microbiota Transfer" OR "Fecal Bacteriotherapy" OR "FMT" OR "Stool ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666354625001073

Exploring the effects of faecal microbiota transplantation on ... Shahnazarian, et al. Fecal Microbiota Transplantation (FMT) with colonoscopy ... Mechanisms underpinning the efficacy of faecal microbiota transplantation in ...

3. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1523870/full

Fecal microbiota transplantation-current perspective on ... Fecal microbiota transplantation (FMT) is a therapeutic intervention that involves transferring processed stool from a healthy donor to restore the balance ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9864694/

The Role of Fecal Microbiota Transplantation in the Treatment ... An increasingly popular method of microbiome modification is fecal microbiota transplantation (FMT). ... Fecal microbiota transplant as a potential treatment for ...

5. e-ce.org e-ce.org/journal/view.php?number=6849

Fecal Microbiota Transplantation: Current Applications ... Fecal microbiota transplantation (FMT), also called stool/fecal transplantation or fecal bacteriotherapy, is the infusion or engraftment of liquid filtrate ...

6. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-024-03781-6

Effect of fecal microbiota transplantation on patients with ... Fecal microbiota transplantation (FMT) has emerged as a promising method for restoring intestinal microbial ecology [19], widely recognized for ...

7. withpower.com withpower.com/trial/fecal-microbiota-transplant-for-parkinsons-disease-8c9e5

Fecal Microbiota Transplant for Parkinson's Disease Is fecal microbiota transplantation (FMT) generally safe for humans? · How is fecal microbiota transplant treatment different from other treatments for ...