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Parkinson DiseasePhase 2EFFACE-PDNCT05204641

Effect of Fecal Microbiota Transfer on Progression of Parkinson Disease

A Phase 2 study testing Fecal Microbiota Transfer provided by Human Biome Institute in people with Parkinson Disease, run by Medical University of Warsaw at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to assess impact of Fecal Microbiota Transfer (FMT) on clinical symptoms of Parkinson's disease. Assesment of tremor, slowness of movements and balance problems before and after FMT will be performed. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
Fecal Microbiota Transfer provided by Human Biome Institute
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
59 participants
Where
1 sitePoland
Study dates
4 Jan 2022to 8 Oct 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Idiopathic PD
  • Consent to undergo colonoscopy

Who cannot join

  • perforation or obstruction of gastroenteric tract,
  • radiotherapy of abdomen or pelvis region
  • severe heart, liver or kidney failure
  • coagulation disorders
  • immunity disorders
  • current viral, bacterial or fungal infection
Show all 10Show fewer
  • abdominal aortic aneurysm qualifying for surgery, pregnancy and lactation treatment with Duodopa, deep brain stimulation or apomorphine
  • colonoscopy confirmed colon polyps, except for lesions <5 mm qualified for the NBI International Colorectal Endoscopic I group or other potentially neoplastic lesions after evaluation in white light and narrow beam imaging (NBI)
  • severe food allergy with a history of anaphylaxis after consumption of the product.
  • microbiological stool evaluation with detection of: methicillin-resistant Staphylococcus aureus (MRSA), Klebsiella pneumoniae carbapenemase (KPC), metallo-β-lactamase (MBL), extended-spectrum beta-lactamase (ESBL), vancomycin-resistant Enterococci (VRE), Salmonella, Shigella, Yersinia. If any other atypical pathogen are to be detected in general stool culture, it will be assessed on an individual basis.

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Department of Neurology, Faculty of health sciences, Medical University of Warsaw

    Warsaw, 03-242

Other trials in Poland

About this study

The aim of the study is to assess impact of Fecal Microbiota Transfer (FMT) on clinical symptoms of Parkinson's disease. Assesment of tremor, slowness of movements and balance problems before and after FMT will be performed. The effect of FMT on frequency of constipations, which are common among Parkinson disease patients and have negative impact on quality of life and drug absorption will also be assessed. Detailed assessment of absorption of levodopa, which is the golden standard of treatment of Parkinson disease, is planned. It is planned to recruit 40 patients with diagnosis of Parkinson disease and indications for colonoscopy (constipations, age >50 years). Patients will be randomly assigned to the group receiving treatment with FMT or identically looking placebo. It will be administered to intestine during colonoscopy. Patients will be assessed by neurologist few times after the procedure. Psychological assessment and examination of gait and balance by physiotherapist is also planned. The last assessment will be performed after 12 months to see if the clinical effect can be observed for such a long time. The composition of the intestinal microbiota will be carefully assessed before and after the procedure in order to identify pathogens that may affect the course of the disease.

Being tested
Fecal Microbiota Transfer provided by Human Biome Institute
Keywords
Fecal Microbiota Transplant
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fecal Microbiota Transfer provided by Human Biome InstituteBiological

    Also called mBiotix, Fecal Microbiota Transplantation

    Fecal Microbiota Transfer with colonoscopy

Study groups in NCT05204641
Study groupRoleWhat they receive
Fecal microbiota transplantActive comparatorPretreatment with rifaximin 3x 400 mg PO for 5 days Fecal Microbiota Transfer from healthy donor during colonoscopy. Assessments in clinical scales: 30 days, 90 days, 180 days and 12 months: Unified Parkinson Disease Rating Scale, modified Constipation Assessment Scale, Parkinson Disease Questionnaire-39, Non- Motor Symptoms Questionnaire, Gastrointestinal Dysfunction Scale for Parkinson Disease. Assessment of levodopa/benserazide 200+50 mg tablet pharmacokinetics before and 30 days and 1 year after intervention
Receives: Biological: Fecal Microbiota Transfer provided by Human Biome Institute
Autotransplant of patients microbiotaPlacebo comparatorPretreatment with rifaximin 3x 400 mg PO for 5 days Administration of auto-FMT during colonoscopy Assessments in clinical scales: 30 days, 90 days, 180 days and 12 months: Unified Parkinson Disease Rating Scale, modified Constipation Assessment Scale, Parkinson Disease Questionnaire-39, Non- Motor Symptoms Questionnaire, Gastrointestinal Dysfunction Scale for Parkinson Disease. Assessment of levodopa/benserazide 200+50 mg tablet pharmacokinetics before and 30 days and 1 year after intervention
Receives: Biological: Fecal Microbiota Transfer provided by Human Biome Institute

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in progression of motor symptoms of Parkinson Diseae

    Reduction or no change in Unified Parkinson Disease Rating Scale part III (motor) in off state (min. 0, max 108 points)

    Measured: 12 months

Secondary outcomes (4)

  1. Change in bowel movements

    Change of score in Gastrointestinal Dysfunction Scale for Parkinson Disease ( a minimum score of 1 and a maximum score of 108)

    Measured: 0,1,3,6,12 months

  2. Change in bowel movements

    Change of score in modified Constipation Assessment Scale (a minimum score of 0 and a maximum score of 16)

    Measured: 0,1,3,6,12 months

  3. Change in MDS- Non Motor Scale and subscales

    Rater-completed assessment that measures frequency and severity of 13 non-motor domains, over 52 items and covers a range of key non-motor symptoms both PD and treatment related

    Measured: 0,1,3,6,12 months

  4. MoCA change

    Detection of dementia symptoms. It is a 30-point assessment that takes about 10 minutes to complete with a physician.

    Measured: It is a 30-point assessment that takes about 10 minutes to complete

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2022
  2. Study start4 Jan 2022
  3. Primary completion8 Oct 2024
  4. Study completion8 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05204641
Sponsor's protocol ID
1
Acronym
EFFACE-PD
Status last verified
Apr 2025
First submitted
29 Nov 2021
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Figura M, Milanowski L, Nowak JM, Antoniak A, Kopczynski M, Zajac W, Sadowski K, Holubiuk L, Walecik-Kot W, Szlufik S, Friedman A, Kaczmarczyk B, Bilinski J, Koziorowski D. Safety and Efficacy of Fecal Microbiota Transplantation in Alleviating Symptoms of Parkinson's Disease: A Randomized, Placebo-Controlled, Double-Blinded Study. Ann Neurol. 2026 Jul;100(1):10-21. doi: 10.1002/ana.78153. Epub 2026 Feb 12.

    PubMed 41674471

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fecal Microbiota Transfer provided by Human Biome Institute in people with Parkinson Disease, run by Medical University of Warsaw at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in progression of motor symptoms of Parkinson Diseae (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05204641, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.

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