Motor symptoms of Parkinson's disease: limb tremors, rigidity, slow and clumsy movements
Conditions
Interventions
Trial Group:Standard DBS surgery + perioperative routine management + structured FMT regimen: oral freeze-dried bacterial capsules, 15 capsules daily for 6 days (total voucher count >2.5×10^13 CFU), s
bowel preparation before FMT: vancomycin 125mg orally every 6 hours for 4 doses + polyethylene glycol (PEG) purgation (3 liters, consumed within 2–3 hours).
Control Group:Standard DBS surgery + perioperative routine management + placebo intervention: starch capsules with identical appearance, administered via the same route, frequency, and duration as the
Sponsors
Shandong Provincial Third Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meets the clinical diagnostic criteria of the UK Parkinson's Disease Society Brain Bank, with a confirmed diagnosis of idiopathic Parkinson's disease. 2. Aged 18–75 years, regardless of gender. 3. Hoehn-Yahr stage 2.5–4 (assessed during the medication "off" period). 4. UPDRS-III motor score >= 30 points during the medication "off" period, or improvement >30% in the acute levodopa challenge test. 5. Has developed motor fluctuations ("on-off" phenomena) and/or motor complications (dyskinesia), and is deemed suitable for bilateral subthalamic nucleus deep brain stimulation (STN-DBS) surgery by a specialist. 6. Comorbid constipation: meets the ROME-IV diagnostic criteria for functional constipation, or gut microbiota dysbiosis defined by a fecal 16S rRNA Shannon diversity index = 20. 8. Able to comply with postoperative follow-up and complete all scales, blood tests, stool samples, and imaging examinations. 9. Signed written informed consent (by the patient or legal representative).
Exclusion criteria
Exclusion criteria: 1. Secondary or atypical Parkinsonian syndromes (vascular, drug-induced, multiple system atrophy, progressive supranuclear palsy, cortical basal ganglia degeneration, etc.). 2. History of previous stereotactic brain surgery, deep brain electrode implantation, or any other intracranial surgery. 3. History of major abdominal surgery (major gastrectomy, intestinal resection, cholecystectomy, abdominal stoma, etc.) or previous intestinal FMT; retention is permissible for >=6 months after simple appendectomy. 4. Active gastrointestinal diseases: inflammatory bowel disease (Crohn's disease, ulcerative colitis), intestinal obstruction, diverticulitis, active gastrointestinal bleeding, or unresected colon polyps >=1 cm. 5. Use of antibiotics, probiotics, prebiotics, synbiotics, or any investigational microbiota preparations within the past 3 months. 6. Known severe gut microbiota dysbiosis-related infections: Clostridioides difficile infection, colonization/infection with multidrug-resistant intestinal bacteria. 7. Immunosuppressive or immunodeficient status: HIV-positive, active tuberculosis, hematologic malignancies, solid organ transplantation, or ongoing immunosuppressive/biological therapy. 8. Severe systemic diseases: decompensated cardiac/liver/renal dysfunction (ALT/AST>2.5×ULN, eGFR 9%), severe COPD, or acute asthma exacerbation. 9. Active infection or high-risk infection: Uncontrolled fever (body temperature >=38°C), pneumonia, urinary tract infection, skin/soft tissue infection; active syphilis, hepatitis B, or hepatitis C; COVID-19 positive status or in isolation period. 10. Severe cognitive impairment or psychiatric disorders: MoCA score =24 points), suicidal tendencies. 11. Severe dysphagia or gastroparesis, unable to tolerate endoscopic jejunal tube FMT procedure. 12. Pregnancy, lactation, or planned pregnancy; positive urine pregnancy test in women of reproductive age. 13. History of allergy to FMT preparation components (bovine serum albumin, glycerol, etc.) or anesthetic/sedative agents. 14. Participation in other clinical trials or use of investigational drugs/instruments within 30 days. 15. Any circumstances that may increase subject risk, interfere with outcome evaluation, or affect compliance as determined by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in MDS-UPDRS Part III (Motor Subscale) Score During 'On' State After DBS Activation;Total NMSS Score and Changes in Subdomains of Constipation, Depression, and Sleep;Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Score;Safety Outcomes (Including DBS-Related Adverse Events [Intracranial Hemorrhage, Seizure, Infection, Stimulation Side Effects], FMT-Related Adverse Events [Gastrointestinal Reactions, Infection, Allergic Reactions], Incidence of Serious Adverse Events [SAEs], Protocol Deviations, and Assessment of Adverse Event-Intervention Causality); | — |
Secondary
| Measure | Time frame |
|---|---|
| DBS Stimulator Parameters (Voltage, Frequency, Pulse Width);On-Time Proportion (Daily Duration of Good Symptom Control);Change in Levodopa Equivalent Daily Dose (LEDD);Depression Symptoms (Hamilton Depression Rating Scale-17, HAMD-17);Sleep Disturbance (Pittsburgh Sleep Quality Index, PSQI);Cognitive Function (Montreal Cognitive Assessment, MoCA);Alpha Diversity of Gut Microbiome (Shannon Index, Chao1 Index);Beta Diversity of Gut Microbiome (Unifrac Distance);Abundance of Specific Bacterial Genera (e.g., Akkermansia muciniphila, Short-Chain Fatty Acid-Producing Bacteria);Serum Biomarkers (IL-6, TNF-a, IL-1ß, IL-10, LBP, Butyrate, Propionate, BDNF);Resting-State Functional MRI (rs-fMRI) Brain Functional Connectivity Strength;IPG Battery Power Consumption Rate (Area Under the Voltage-Time Curve); | — |
Countries
China
Contacts
Public ContactLi Pengbo
Shandong Provincial Third Hospital
Outcome results
None listed