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Magnetic resonance imaging study of the effect of probiotics on the improvement of motor symptoms and the effect on brain function and metabolism in patients with Parkinson's disease

Magnetic resonance imaging study of the effect of probiotics on the improvement of motor symptoms and the effect on brain function and metabolism in patients with Parkinson's disease

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065638
Enrollment
Unknown
Registered
2022-11-10
Start date
2020-11-04
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Parkinson's Disease

Interventions

intervention group:Beifido and or Bacillus licheniformis 2 capsules tid
control group:Keep the original anti-Parkinson's disease medication

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 40-80 years old, no gender limitation; 2. Primary Parkinson's disease patients, meeting the clinical diagnostic criteria for Parkinson's disease MDS (2015); 3. Parkinson's disease motor symptoms stable 1 month before enrollment, There is no need to frequently adjust Parkinson's disease medication in the short term; 4. No intestinal probiotics or prebiotic therapy (including lactulose) was used for 2 months before enrollment, if used, a 2-month washout period should be performed; 5. No CT, MR Check the contraindications; 6. Understand and agree to follow the research protocol, agree to join the group and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Parkinson's plus syndrome and secondary Parkinson's syndrome, such as multiple system atrophy, progressive supranuclear palsy, cortical subganglion degeneration, dementia with Lewy bodies, vascular Parkinson's syndrome, post-encephalitic Parkinson's syndrome Symptoms, or any other non-primary Parkinson's disease; 2. Take any probiotics or prebiotics (including lactulose) and antibiotics within 2 months before enrollment; 3. Combined endocrine diseases, such as diabetes or fasting blood sugar exceeding normal values Upper limit, hyperthyroidism or hypothyroidism, adrenal tumor, history of pituitary dysfunction, etc.; 4. Combined with other neurological diseases, such as cognitive impairment, MMSE scale score 17, Hamilton Anxiety Scale score >14, or taking antidepressant anxiety medication); malignancy, myelopathy, epilepsy, autonomic disorders (urinary retention, incontinence, or orthostatic hypostasis) Blood pressure, blood pressure drops more than 30/15mmHg after standing upright for 5 minutes), etc.; new onset of cerebrovascular disease or sequelae of severe cerebrovascular disease within 3 months, affecting the assessor; 5. Gastrointestinal tumor, history of inflammatory bowel disease, 3 months Other acute and chronic inflammation of the gastrointestinal tract (including acute exacerbation of cholecystitis); 6. History of gastrointestinal surgery (excluding endoscopic resection of benign gastrointestinal polyps, appendicitis) or constipation caused by surgery; 7. Anus fissure, perianal abscess, irreducible prolapse, history of pelvic trauma. 8. Severe cardiovascular disease (such as congestive heart failure with cardiac function class III-IV by the American Heart Association, history of myocardial infarction within 6 months, etc.); 9. Severe liver and kidney dysfunction, alanine aminotransferase, aspartate aminotransferase , total bilirubin is higher than 1.5 times the upper limit of normal; serum creatinine is higher than 1.5 times the upper limit of normal; 10. Pregnant and lactating women or women of gestational age 40-60 years old with positive HCG; 11. Known test results Those who are allergic to drugs or related products; 12. Those who have abnormal brain routine MR imaging; 13. Those who have a history of drug abuse or alcohol dependence; 14. Those who have participated in other clinical trials within 3 months before enrollment; 15. Those who refuse to be enrolled and patients who cannot cooperate with the investigator; the investigator judges that they are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Unified Parkinson Disease Rating Scale (UPDRS);Magnetic resonance imaging changes of brain function and metabolism;

Secondary

MeasureTime frame
RBD Questionnaire–Hong Kong;Parkinson's disease sleep scale 2;Bristol stool classification;Patient Assessment of Constipation Symptoms;

Countries

China

Contacts

Public ContactHouzhen Tuo

Beijing Friendship Hospital, Capital Medical University

tuohouzhen@ccmu.edu.cn+86 18801118091

Outcome results

None listed

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