Exploring the therapeutic mechanism of probiotic intervention in people at the prodromal stage of Parkinson's disease based on the microbiota-gut-brain axis and multi-omics approaches.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400080434

Enrollment

Unknown

Registered

2024-01-29

Start date

2024-02-01

Completion date

Unknown

Last updated

2024-02-05

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

Conditions

Parkinso's disease

Interventions

experimental group:The combination therapy of probiotics and prebiotics.

control group:The placebo treatment of prebiotics and probiotics.

Eligibility

Sex/Gender

All

Age

45 Years to 70 Years

Inclusion criteria

Inclusion criteria: a) Inclusion criteria for the PD prodromal group: ? Participants in the PD prodromal stage meeting the diagnostic criteria of MDS2015; ? Motor symptom score: 4 points = UPDRS III score = 15 points; ? MMSE = 24 points; ? No probiotic supplements or antibiotics taken in the last three months; ? Age = 45 and = 70 years. b) Inclusion criteria for the normal control group: Matched normal controls recruited concurrently with the PD prodromal participants, all meeting the following criteria: ? No complaints of neurological or psychiatric disorders, no severe physical illnesses, and cooperative during examination; ? MMSE total score = 24 points; ? No intake of probiotic supplements or antibiotics in the last three months.

Exclusion criteria

Exclusion criteria: Exclusion criteria for inclusion: ? Atypical or secondary Parkinson's syndrome; a history of clear cerebral stroke, encephalitis, etc.; ? Severe chronic diseases, including severe cardiovascular, hepatic, renal, pulmonary, and hematopoietic system disorders such as heart failure and renal failure; ? Other psychiatric disorders such as schizophrenia; ? History of alcohol/drug dependence; ? Chronic digestive system diseases, including inflammatory bowel disease, tumors, and intestinal obstruction, as well as patients with a history of gastrointestinal surgery, leading to severely impaired intestinal barrier due to reasons such as sepsis; ? Confirmed allergy to any component of the experimental drug and/or its excipients; ? Individuals with contraindications for PET-MR.

Design outcomes

Primary

Measure	Time frame
MDS-UPDRS ? socre;The improvement rate of gastrointestinal symptoms.;	—

Secondary

Measure	Time frame
Changes in gut microbiota.;Changes in non-motor symptoms.;Moca;HAMA HAMD;	—

Countries

CHINA

Contacts

Public ContactLiu Weiguo

Brain Hospital Affiliated to Nanjing Medical University

liuweiguo1111@sina.com+86 139 1472 5569

Outcome results

None listed

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