Effect of Fecal Microbiota Transfer on Progression of Parkinson Disease

Parkinson Disease Clinical Trial

— EFFACE-PD  

Official title:

Effect of Fecal Microbiota Transfer on Progression of Parkinson Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05204641
• Other study ID #: 1
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: October 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Biological:
• Fecal Microbiota Transfer provided by Human Biome Institute
Fecal Microbiota Transfer with colonoscopy

Locations

Country	Name	City	State
Poland	Department of Neurology, Faculty of health sciences, Medical University of Warsaw	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Human Biome Institute S.A.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of levodopa bioavailability	Change in levodopa-carbidopa concentration in peripheral blood (AUC)	3 months
Primary	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)	12 months
Secondary	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)	12 months
Secondary	Change in bowel movements	Change of score in Constipation Assessment Scale (a minimum score of 0 and a maximum score of 16)	12 months