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

20 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Fecal Microbiota Transplant for Parkinson's Disease?

Research shows that Fecal Microbiota Transplant (FMT) can improve symptoms in Parkinson's Disease patients, such as motor and non-motor symptoms, including constipation. Studies found that FMT led to significant improvements in various clinical scores and increased the diversity of gut bacteria, which is linked to better health outcomes. ^{1 2 3 4 5}

Is fecal microbiota transplantation (FMT) generally safe for humans?

FMT is considered safe in the short term, especially for treating recurrent Clostridium difficile infections, and no severe adverse effects were observed in a trial with Parkinson's disease patients. However, there are still questions about long-term safety and standardized protocols. ^{2 3 6 7 8}

How is fecal microbiota transplant treatment different from other treatments for Parkinson's disease?

Fecal microbiota transplant (FMT) is unique because it involves transferring healthy gut bacteria from a donor to a patient, aiming to restore balance in the gut microbiome, which is thought to influence Parkinson's disease. Unlike traditional treatments that focus on managing symptoms, FMT targets the gut-brain connection and may improve both gastrointestinal and neurological symptoms. ^{1 2 3 4 9}

What is the purpose of this trial?

FMT may significantly improve quality of life and Parkinson Disease (PD) symptom severity measurements. We hypothesize that gut microbial dysbiosis is a major contributing factor in Parkinson's disease.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation therapy for Parkinson's disease: A preliminary study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of fecal microbiota transplantation in patients with Parkinson's disease: clinical trial results from a randomized, placebo-controlled design. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation to treat Parkinson's disease with constipation: A case report. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation in Parkinson's disease-A randomized repeat-dose, placebo-controlled clinical pilot study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of fecal microbiota transplantation in Parkinson's disease patients with constipation. [2021]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Fecal Microbiota Transplantation: Current Applications, Effectiveness, and Future Perspectives. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation in gastrointestinal and extraintestinal disorders. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation in disease therapy. [2020]

9. China pubmed.ncbi.nlm.nih.gov

[Advances in fecal microbiota transplantation for treatment of Parkinson's disease]. [2021]