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A randomized double-blind trial of fecal microbiota transplantation in the treatment of Parkinson's disease

A randomized double-blind trial of fecal microbiota transplantation in the treatment of Parkinson's disease

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050380
Enrollment
Unknown
Registered
2021-08-27
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson disease

Interventions

Group 1:Donor FMT
Group 2:Autologous FMT

Sponsors

Huai'an First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patient inclusion criteria: (1) All patients meet the diagnostic criteria for primary Parkinson's disease (MDS criteria); (2) Hoehn-Yahr score of 3-5; (3) Signed informed content. 2. Donor inclusion criteria: (1) 18-75 years old, health volunteers; (2) Meet the U.S. FDA and European consensus screening standards; (3) Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria for patients: (1) Cognitive impairment and other serious neurological diseases; (2) Primary gastrointestinal diseases; (3) Gastrointestinal or abdominal surgery; (4) Autoimmune system diseases; (5) Malignant tumor patients; (6) The use of probiotics or antibiotics within three months prior to FMT; (7) Pregnancy; (8) Alcohol addiction or drug abuse; (9) Severe heart, liver, and renal insufficiency; (10) Colonoscopy contraindications; (11) Aged > 80 years. 2. Existence criteria for donors: (1) The use of probiotics or antibiotics within three months prior to donation; (2) Malignant tumor or family history of Parkinson's disease; (3) History of infectious diseases.

Design outcomes

Primary

MeasureTime frame
Movement Disorder Society-Sponsored Revision Uni?edParkinson's Disease Rating Scale (MDS-UPDRS);

Secondary

MeasureTime frame
Non-Motor Symptom Scale (NMSS);Parkinson's Disease Questionnaire (PDQ-39);Montreal Cognitive Assessment (MoCa);Rome IV;

Countries

China

Contacts

Public ContactYang Xiaozhong

Huai'an First People's Hospital

hayyyxzh@njmu.edu.cn+86 13852389799

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026