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Clinical study for therapeutic value of faecal microbiota transplantation (FMT) improving Intestinal microecological environment in patients with Parkinson's disease

Clinical study for the safety and efficacy of fecal microbiota transplantation in the treatment of Parkinson's disease

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021405
Enrollment
Unknown
Registered
2019-02-19
Start date
2019-02-28
Completion date
Unknown
Last updated
2022-08-16

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

Conditions

Parkinson's disease

Interventions

experimental group:FMT with conventional PD therapy
Placebo group:Placebo with conventional PD therapy

Sponsors

Army Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Male and female aged 30 to 85 years; 2) Patients with early Parkinson's disease are definitely diagnosed as having h-y1 ~3 grade of Parkinson's disease in accordance with the diagnostic criteria for Parkinson's disease in China (2016 edition); 3) with normal communication skills; 4) Sign informed consent and agree to participate in this study.

Exclusion criteria

Exclusion criteria: 1) Complicated with other serious diseases of the heart, liver, kidney, respiratory, digestive, blood and endocrine systems; 2) Combined with intestinal double infection, such as CDI, ehec, salmonella, shigella, campylobacter, plague, and cytomegalovirus; 3) Liver function was significantly abnormal or had the following liver disease history: AST or ALT was twice higher than the upper limit of normal value, history of liver cirrhosis, hepatic encephalopathy, history of esophageal varicose veins or portal shunt; 4) With evidence of renal damage or the following renal disease history: serum creatinine is 1.5 times higher than the upper limit of normal value;The history of dialysis;Or a history of nephrotic syndrome; 5) Patients with various acute infections, tumors and severe arrhythmias, mental disorders, drug or alcohol addiction ; 6) Pregnant or lactating women; 7) Have used antibiotics or microecological agents in the past 4 weeks; 8) Patients with allergy or contraindications to "enterobacteria capsule" used in this study; 9) Clinical researchers with other related Parkinson's disease were being conducted at the time of enrollment or within 3 months before enrollment; 10) It is difficult to complete the interview, or various factors affecting the compliance.

Design outcomes

Primary

MeasureTime frame
UPDRS scale;

Secondary

MeasureTime frame
IBS-SSS;Gastrointestinal Symptom Rating Scale;BRISTOL stool form scale;IBS-QOL;UPDRS scale;The change of gut microbiota after intervention;PHQ-9 scale;GDS-15 scale;GAD-7 scale;Montreal Cognitive Assessment;Mini-mental State Examination;Adverse effect;

Countries

China

Contacts

Public ContactDongFeng Chen

Army Medical Center

Chendf1981@126.com+86 13883032812

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026