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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Administration of donor FMT; Other: Administration of placebo

• Registration Number: NCT04854291
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-17
• Study First Posted: 2021-04-22
• Study Start: 2021-04-25
• Primary Completion: 2022-12-27
• Study Completion: 2023-06-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Donor FMT	Administration of donor FMT	FMT from a healthy donor
Placebo	Administration of placebo	NaCl + glycerol mixture (carrier solution of FMT arm)

Primary Outcome Measures

Name	Time	Method
Change of the sum of MDS-UPDRS I-III from baseline	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 Outcome Measures

Name	Time	Method
Change of Timed UP GO test from baseline	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
Change of MDS-UPDRS I from baseline	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)
Change of NMSS from baseline	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)
Change in gut permeability, motility and volume from baseline	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
Change of fecal and blood markers from baseline	whole study period	Shotgun metagenomics based taxonomic microbiota survey, metabolomics, inflammatory markers, DNA methylation
Change of BDI-II from baseline	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)
Change of BAI from baseline	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)
Change of RBDSQ from baseline	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.
Change of MoCa from baseline	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)
Change of IBS-SSS from baseline	at 6 and 12 months after intervention	The irritable bowel severity scoring system will be determined at baseline and follow-up
Change of PDQ39 index from baseline	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)
Change of MDS-UPDRS III from baseline	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)
Change of MDS-UPDRS IV from baseline	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)

Trial Locations

Locations (4)

Päijät-Häme Central Hospital; 🇫🇮 Lahti, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Turku University Hospital; 🇫🇮 Turku, Finland