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A Single-Center Observational Study on the Correlation Between Gut Microbiota and Metabolites with Disease Progression in Patients with Parkinson’s Disease

An Analysis of the Association Between Gut Microbiota and Its Metabolites with Disease Progression in Parkinson's Disease Patients Based on Case-Control and Staging Design: A Single-Center Observational Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098027
Enrollment
Unknown
Registered
2025-02-28
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Parkinson's Disease

Interventions

late stage PD patients:no
middle stage PD patients:no
Early stage PD patients:no

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.This study's participant population consisted of inpatients with Parkinson's Disease (PD) admitted to the neurology and neurosurgery departments of our hospital, as well as outpatients picking up medications for PD. The inclusion criteria were patients aged 18 and above diagnosed with PD according to clinical diagnostic guidelines. All PD patients were confirmed by two or more senior neurology physicians based on these guidelines, and those who did not initially meet the criteria were excluded. The exclusion of healthy controls was determined jointly by research assistants and outpatient physicians after assessment. The diagnostic criteria required the following: Patients showed a clear and significant response to dopaminergic drug treatment. During the initial treatment period, the patient's function could be restored or nearly restored to normal levels. In cases where there was no clear documentation, a significant response to initial treatment could be defined as either: a marked improvement in symptoms with an increase in medication dose, or a significant worsening of symptoms with a reduction in dose. These changes could be determined through objective scoring (an improvement in the UPDRS-III score of more than 30% post-treatment) or subjective description (reliable and significant changes in condition reported by the patient or caregiver). There was also the presence of clear and significant "on/off" symptom fluctuations, including predictable end-of-dose phenomena to some extent. The presence of Levodopa-induced dyskinesias. Clinical examination observed resting tremor in an individual limb (either in the past or during the current examination). Positive results in the following auxiliary tests helped differentiate Parkinson's disease from atypical parkinsonian syndromes: the presence of olfactory loss or anosmia, or hyperechogenicity of the substantia nigra (>20 mm²) shown by transcranial sonography, or cardiac sympathetic denervation demonstrated by metaiodobenzylguanidine scintigraphy. Patients were categorized into early, middle, and late stages of PD according to the Unified Parkinson’s Disease Rating Scale (UPDRS) and Hoehn & Yahr staging scale. All enrolled patients were informed about the study and voluntarily signed the informed consent form. 2.The inclusion criteria for the healthy control group typically do not exhibit clinical features of PD and are screened through clinical examinations to exclude: (1) No significant somatic diseases (including heart, liver, kidney, brain, and other vital organ diseases) or medical history, no major infectious diseases or history of contact with infectious diseases, and no history or family history of psychiatric disorders; (2) Physical examination and laboratory tests (routine blood and urine tests, blood biochemistry, electrocardiogram, chest X-ray) show no abnormalities or abnormalities that are not clinically significant; (3) Participants provide informed consent and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.The diagnosis of Parkinson's disease can be ruled out if any of the following conditions is met (but symptoms caused by other clear reasons should not be included, such as trauma, etc.): (1) There is a clear cerebellar ataxia or cerebellar oculomotor abnormality (persistent gaze-evoked nystagmus, huge square wave jumping, and super-rhythmic saccade); (2) There is a downward vertical supranuclear gaze palsy or selective slowing of downward vertical saccades.; (3) Within 5 years after the onset of the disease, the patient is diagnosed with a high suspicion of behavioral variant frontotemporal dementia or primary progressive aphasia; (4) Three years after the onset of the disease, Parkinson-like symptoms are still limited to the lower limbs; (5) The Parkinsonian syndrome induced by dopamine receptor blockers or dopamine-depleting agents is consistent with the dose and duration of drug-induced Parkinsonism; (6) Although the severity of the disease is moderate (that is, according to the MDS-UPDRS, the score for assessing muscle rigidity or bradykinesia is greater than 2 points), the patient has no significant therapeutic response to high-dose (not less than 600 mg/d) levodopa treatment; (7) There is a clear loss of cortical complex sensation (such as damage to the sense of writing on the skin and the sense of object recognition when the main sensory organs are intact), as well as a clear ideational apraxia of limbs or progressive aphasia; (8) Molecular neuroimaging examination shows normal function of the presynaptic dopaminergic system; (9) There is a clear cause that can lead to Parkinsonian syndrome or is suspected to be related to the patient's symptoms, or based on a comprehensive diagnostic assessment, professional physicians judge that it may be another syndrome rather than Parkinson's disease; (10) PD patients who are unwilling to sign the informed consent form for participants.

Design outcomes

Primary

MeasureTime frame
Flora;Metabolomics;Proteomics;

Countries

China

Contacts

Public ContactPeng Huang

Peking University Shenzhen Hospital

327203498@qq.com+86 13534076024

Outcome results

None listed

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