Status:
UNKNOWN
Role and Mechanism of Probiotics in Improving Motor Symptoms in Mild to Moderate Parkinson's Disease
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
Parkinson Disease
Parkinsonian Disorders
Eligibility:
All Genders
40-85 years
Phase:
PHASE4
Brief Summary
This study is a multicenter randomized double-blind placebo-controlled study. The research content is 1. The improvement effect of Bifidobacterium triple viable capsules（BIFICO） on motor symptoms and ...
Detailed Description
This was a multicenter randomized double-blind placebo-controlled study that included 240 patients with primary PD with modified H-Y stage 1-3, randomly divided into treatment and placebo control grou...
Eligibility Criteria
Inclusion
- Age 40-85 years old, both male and female;
- Patients with primary Parkinson's disease who meet the 2015 MDS clinical diagnostic criteria; PD with modified Hoehn-Yahr stage 1-3 and MDS-UPDRS II+III score ≥ 14 and no significant off periods or off periods ≤ 1.5 hours per day (excluding morning motor inability);
- Pre-enrollment therapeutic medications included Levodopa complex preparation, and all Parkinson's disease medications were unadjusted and motor symptoms were stable for 28 days prior to enrollment;
- No probiotic or/and prebiotic (including lactulose) and antibiotic therapy for 60 days prior to enrollment, and if so, a 60-day washout period;
- Understand and agree to follow the study protocol, agree to be enrolled and sign the informed consent form.
Exclusion
- Parkinson's superimposed syndrome and secondary Parkinson's syndrome, such as multiple system atrophy, progressive supranuclear palsy, etc.；
- Taking any probiotic or prebiotic (including lactulose) within 60 days prior to enrollment; having inflammation at any site and using any antibiotic within 60 days prior to enrollment; or having blood leukocytes above the upper limit of normal at screening；
- Combined endocrine disorders, such as history of diabetes or fasting glucose ≥ 7.8 mmol/L;
- Comorbid other neurological disorders, such as cognitive impairment, Mini-Mental State Examination （MMSE） scale score \<24; severe anxiety states and/or severe depressive states (Hamilton Depression Inventory-17 item score \>17, Hamilton Anxiety Scale score ≥14, or being treated with antidepressant anxiety medication); Note: Those who were taking antidepressant and anxiety drugs and had no adjustment in the last 28 days, and whose score of Hamilton Depression Scale -17 was less than 17, and Hamilton Anxiety Scale score was less than 14 were not included in the exclusion criteria; Severe autonomic nervous disease occurs within 5 years of onset, malignancy, spinal cord lesions, epilepsy, autonomic disorders (urinary retention, urinary incontinence, or upright hypotension , blood pressure drop ≥30/15 mmHg at any time point within 5 minutes of uprightness), etc.; new cerebrovascular disease or sequelae of severe cerebrovascular disease within 6 months, which affects the assessment；
- Gastrointestinal tumors, history of inflammatory bowel disease, other acute and chronic inflammation of the gastrointestinal tract (including acute attacks of cholecystitis) within 3 months；
- History of gastrointestinal surgery (excluding endoscopic resection of gastrointestinal benign polyps, appendicitis resection) or constipation caused by surgery；
- History of anal fissure, perianal abscess, irreversible anal prolapse, pelvic trauma；
- Severe cardiovascular disease (such as congestive heart failure with a heart function classification of Ⅲ-Ⅳ by the American Heart Association, a history of myocardial infarction within 6 months, etc.);
- Severe liver and kidney dysfunction with glutamate-pyruvate transaminase, aspartate transaminase and total bilirubin 2.0 times higher than the upper limit of normal; serum creatinine 2.0 times higher than the upper limit of normal;
- Pregnant and lactating women or women of childbearing age (40-60 years) who are human chorionic gonadotropin (HCG)-positive;
- Known allergy to test drugs or related products;
- People with a history of drug abuse or alcohol dependence;
- Those who have participated in other clinical trials within 3 months prior to enrollment;
- Refusal to enroll and inability to cooperate with the investigator; patients judged by the investigator to be unsuitable for enrollment.
Key Trial Info
Start Date :
November 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04871464
Start Date
November 11 2021
End Date
December 1 2023
Last Update
February 21 2023
Active Locations (10)
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1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
2
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
3
Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050
4
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050