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Completed

NCT Number: NCT04854291

A Trial of Fecal Microbiome Transplantation in Parkinson's Disease Patients

48 PD patients (age 35-75y; H&Y 1-3) testing positive in a stool PD-dysbiosis test will be randomized in a 2:1 ratio to receive either donor FMT or their own stool through intracaecal infusion. The main outcome measure will be the sum of MDS-UPDRS I-III at 6 months to cover motor and non-motor symptom changes. A wide array of secondary clinical outcome measures will be assessed longitudinally and a large array of measurements, biospecimens (stool, urine, blood, colonic biopsies), and imaging data will be collected for further analysis at baseline, 1, 6, and 12 months.

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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

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Central Hospital, Helsinki, Finland

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of idiopathic PD (Clinically Probable PD)
  • H&Y OFF 1-3 at Baseline Visit

Exclusion criteria

  • Chronic gastrointestinal disease (IBS allowed, celiac disease allowed if on gluten free diet, gastritis allowed)
  • Any previous major gastrointestinal surgery that may alter gastrointestinal physiology
  • Any abdominal surgery in the last 3 months
  • Major genital and/or rectum prolapse
  • Active autoimmune disease
  • Active cancer within 5 years (allowed: basalioma and successfully removed carcinoma in situ)
  • Immune deficiency
  • HIV infection
  • Antibiotic use in last 3 months before baseline visit
  • Dementia as indicated by Moca <21p
  • Psychosis
  • Active significant impulse control disorder (by interview and medical records)
  • Major depression as indicated by BDI-II >28
  • Pregnancy
  • Alcohol or drug abuse
  • Negative dysbiosis test result
  • Iodine allergy
  • Deep brain stimulation or Duodopa/Lecigon treatment
  • Inability to interrupt regular use of NSAIDs for at least one month before permeability assessments

Treatment and study plan

Administration of donor FMT

Other

Intracaecal infusion of FMT

Administration of placebo

Other

Intracaecal infusion of carrier solution

Primary outcomes

  1. Change of the sum of MDS-UPDRS I-III from baseline

    Time frame: at 6 months post intervention

    Sum of Movement Disorder Society Unified Parkinson's Disease Rating Scale sum of parts I, II, and III (in OFF state); Min 0 - Max 236 points (higher points indicating worse symptoms) will be determined at baseline and at 6 months after intervention. The difference between these values will be the primary outcome measure; Min 0 - Max 236 points (higher points indicating stronger improvement)

Secondary outcomes

  1. Change of MDS-UPDRS III from baseline

    Time frame: at 6 and 12 months post intervention

    Movement Disorder Society Unified Parkinson's Disease Rating Scale part III (in OFF state); Min 0 - Max 132 points (higher points indicating worse symptoms) will be determined at baseline and at 6 and 12 months after intervention. The difference between these values will be calculated; Min 0 - Max 132 points (higher points indicating stronger improvement)

  2. Change of MDS-UPDRS IV from baseline

    Time frame: at 6 and 12 months post intervention

    Movement Disorder Society Unified Parkinson's Disease Rating Scale part IV; Min 0 - Max 132 points (higher points indicating worse symptoms) will be determined at baseline and at 6 and 12 months after intervention. The difference between these values will be calculated; Min 0 - Max 24 points (higher points indicating stronger improvement)

  3. Change of Timed UP GO test from baseline

    Time frame: at 6 and 12 months post intervention

    measured in seconds, higher value indicating worse clinical symptoms expressed as difference between 6 and 12 month post intervention and baseline, higher value indicating stronger improvement

  4. Change of MDS-UPDRS I from baseline

    Time frame: at 6 and 12 months post intervention

    Movement Disorder Society Unified Parkinson's Disease Rating Scale part I; Min 0 - Max 52 points (higher points indicating worse symptoms) will be determined at baseline and at 6 months after intervention. The difference between these values will be calculated; Min 0 - Max 52 points (higher points indicating stronger improvement)

  5. Change of NMSS from baseline

    Time frame: at 6 and 12 months post intervention

    Non-motor symptom scale (0-360 points, higher points indicating worse symptoms) will be determined at baseline and at 6 and 12 months after intervention. The difference between these values will be calculated; Min 0 - Max 360 points (higher points indicating stronger improvement)

  6. Change in gut permeability, motility and volume from baseline

    Time frame: at 6 months

    Gut permability is studied using the Iohexole test.Motility and volume is studied using radio-opaque markers and volume measurments from abdominal CT scans

  7. Change of fecal and blood markers from baseline

    Time frame: whole study period

    Shotgun metagenomics based taxonomic microbiota survey, metabolomics, inflammatory markers, DNA methylation

  8. Change of BDI-II from baseline

    Time frame: at 6 and 12 months post intervention

    Beck Depression Inventory II (0-63 points, higher points indicating worse symptoms) will be determined at baseline and at 6 and 12 months after intervention. The difference between these values will be calculated; Min 0 - Max 63 points (larger decrease indicating stronger improvement)

  9. Change of BAI from baseline

    Time frame: at 6 and 12 months post intervention

    Beck Anxiety inventory will be determined at baseline and at 6 and 12 months after intervention.

    The difference between these values will be calculated; Min 0 - Max 63 points (larger decrease indicating stronger improvement)

  10. Change of RBDSQ from baseline

    Time frame: at 6 and 12 months after intervention

    REM sleep behavior disorder screening questionnaire will be determined at baseline and at 6 and 12 months after intervention.

  11. Change of MoCa from baseline

    Time frame: at 6 and 12 months post intervention

    MONTREAL COGNITIVE ASSESSMENT (0-30 points, higher points indicating less symptoms) will be determined at baseline and at 6 and 12 months after intervention. The difference between these values will be calculated; Min 0 - Max 30 points (higher increase indicating stronger improvement)

  12. Change of IBS-SSS from baseline

    Time frame: at 6 and 12 months after intervention

    The irritable bowel severity scoring system will be determined at baseline and follow-up

  13. Change of PDQ39 index from baseline

    Time frame: at 6 and 12 months post intervention

    Parkinson's Disease Questionnaire 39 index (0-100 points, higher points indicating worse quality of life) will be determined at baseline and at 6 and 12 months after intervention. The difference between these values will be calculated; Min 0 - Max 100 points (larger decrease indicating stronger improvement)

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Central Hospital of Paijat-Hame
  • Tampere University Hospital
  • Turku University Hospital
  • University of Aarhus
  • University of Helsinki

Registry information

Official study title

A Randomized, Double Blind, Placebo Controlled Multicenter Trial of Fecal Microbiome Transplantation Safety and Efficacy for Parkinson's Disease Patients With Abnormal Gut Microbiota Composition

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 22, 2021
Registry last updated
Oct 10, 2024

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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