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

Parkinson Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04854291
• Other study ID #: PD-FMT
• Status: Completed
• Phase: N/A
• Start date: April 25, 2021
• Est. completion date: June 13, 2023

Study information

• Verified date: September 2023
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 13, 2023
• Est. primary completion date: December 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Administration of donor FMT
Intracaecal infusion of FMT
• Administration of placebo
Intracaecal infusion of carrier solution

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki
Finland	Päijät-Häme Central Hospital	Lahti
Finland	Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the sum of MDS-UPDRS I-III from baseline	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)	at 6 months post intervention
Secondary	Change of MDS-UPDRS III from baseline	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)	at 6 and 12 months post intervention
Secondary	Change of MDS-UPDRS IV from baseline	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)	at 6 and 12 months post intervention
Secondary	Change of Timed UP GO test from baseline	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	at 6 and 12 months post intervention
Secondary	Change of MDS-UPDRS I from baseline	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)	at 6 and 12 months post intervention
Secondary	Change of NMSS from baseline	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)	at 6 and 12 months post intervention
Secondary	Change in gut permeability, motility and volume from baseline	Gut permability is studied using the Iohexole test.Motility and volume is studied using radio-opaque markers and volume measurments from abdominal CT scans	at 6 months
Secondary	Change of fecal and blood markers from baseline	Shotgun metagenomics based taxonomic microbiota survey, metabolomics, inflammatory markers, DNA methylation	whole study period
Secondary	Change of BDI-II from baseline	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)	at 6 and 12 months post intervention
Secondary	Change of BAI from baseline	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)	at 6 and 12 months post intervention
Secondary	Change of RBDSQ from baseline	REM sleep behavior disorder screening questionnaire will be determined at baseline and at 6 and 12 months after intervention.	at 6 and 12 months after intervention
Secondary	Change of MoCa from baseline	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)	at 6 and 12 months post intervention
Secondary	Change of IBS-SSS from baseline	The irritable bowel severity scoring system will be determined at baseline and follow-up	at 6 and 12 months after intervention
Secondary	Change of PDQ39 index from baseline	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)	at 6 and 12 months post intervention