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Completed

NCT Number: NCT05204641

Effect of Fecal Microbiota Transfer on Progression of Parkinson Disease

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Warsaw, 03-242, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Idiopathic PD
  • Consent to undergo colonoscopy

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Fecal Microbiota Transfer provided by Human Biome Institute

Biological

Fecal Microbiota Transfer with colonoscopy

Other names: mBiotix, Fecal Microbiota Transplantation

Primary outcomes

  1. Change in progression of motor symptoms of Parkinson Diseae

    Time frame: 12 months

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

Secondary outcomes

  1. Change in bowel movements

    Time frame: 0,1,3,6,12 months

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

  2. Change in bowel movements

    Time frame: 0,1,3,6,12 months

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

  3. Change in MDS- Non Motor Scale and subscales

    Time frame: 0,1,3,6,12 months

    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

  4. MoCA change

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

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

Other outcomes

  1. Change of levodopa bioavailability

    Time frame: 1 months, 12 months

    Change in levodopa-carbidopa concentration in peripheral blood (AUC)

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Collaborators

  • Human Biome Institute S.A.

Registry information

Acronym: EFFACE-PD

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 24, 2022
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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