A Phase 4 interventional study of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules and Placebo in Parkinson Disease, Parkinsonian Disorders and Basal Ganglia Diseases, sponsored by Beijing Friendship Hospital. Status unknown at 10 sites in China. Open to participants aged 40 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by Beijing Friendship Hospital · Phase 4, Interventional, and Treatment
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 constipation and sleep in mild to moderate Parkinson's disease and the safety of the study; 2. the mechanism of the improvement effect of intestinal microecological changes on motor and constipation symptoms in mild to moderate Parkinson's disease.
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 groups; On the basis of the original PD medication, the treatment group was given bifidobacterium triple viable capsules (BIFICO) and the control group was given placebo; Patients who met the diagnosis of constipation were given Macrogol 4000 powder and /or Enema glycerine as a rescue medicine, and the observation period was 12+12 weeks.
All subjects underwent the World Movement Disorders Society Parkinson's Disease Comprehensive Rating Scale (MDS-UPDRS), Rome IV Constipation Diagnostic Scale, Cleveland Rating Scale, Parkinson's Disease Sleep Scale-2 (PDSS-2), and General Clinical Outcome Inventory (CGI) scores before and after treatment, and also recorded the patients' single bowel movement time and the use of Macrogol 4000 powder and Enema glycerine , to investigate the improvement effect of Bifido on motor symptoms and non-motor symptoms in PD patients. For the above patients, stool and blood samples were collected at the time of enrollment and at 12 weeks of observation.
At the same time,120 age-and gender-matched healthy adults without constipation were recruited, and their stool and blood samples were collected; the stool samples of PD patients before and after treatment and healthy controls were subjected to the determination of fecal flora 16S DNA abundance. Stool samples of 10 PD patients and 10 healthy controls were taken from each group for metagenomic sequencing. Detection of small molecule metabolites, PD-related genes in blood. To investigate the effect of BIFICO on levodopa pharmacokinetics, levodopa pharmacokinetic measurements will be performed at Friendship Hospital. For patients who agree to participate and sign the informed consent form, blood specimens will be collected consecutively at Visit 2 and Visit 11 after taking Levodopa and Benserazide Hydrochloride Tablets for levodopa blood concentration measurement.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 240 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
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Exclusion Criteria:
Bifidobacterium triple viable capsules（BIFICO），containing Bifidobacterium longum, Lactobacillus acidophilus and Enterococcus faecalis(each ≥ 1.0×10\^7 CFU/capsule)，Day 1-14, 2 capsules twice daily; Day 15-24 weeks, 4 capsules twice daily, taken orally half an hour after meals.
Drug: Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules
Placebo，day 1-14, 2 capsules twice daily; Day 15-24 weeks, 4 capsules twice daily, taken orally half an hour after meals.
Other: Placebo
Healthy subjects without constipation matched for age and sex to PD subjects
Oral
Also known as: BIFICO
Oral
Movement Disorder Society Unified Parkinson's Disease Rating Scale(MDS-UPDRS)Ⅱ+Ⅲ
Part Ⅱ：This measures the motor aspects of activity of daily living and consists of 13 items with scores between 0- 52. Part Ⅲ：This measures the severity of motor symptoms using 18 items (score 0-72). Higher score indicates high severity.
Time frame: 12 weeks
Proportion of MDS-UPDRS II+III total score change <3 points
Proportion of patients whose total score of MDS-UPDRS Ⅱ+Ⅲ changed from baseline by less than 3 points
Time frame: 12 weeks
Movement Disorder Society Unified Parkinson's Disease Rating Scale(MDS-UPDRS)Ⅱ+Ⅲ
Part Ⅱ：This measures the motor aspects of activity of daily living and consists of 13 items with scores between 0- 52. Part Ⅲ：This measures the severity of motor symptoms using 18 items (score 0-72). Higher score indicates high severity.
Time frame: 24 weeks
Proportion of MDS-UPDRS II+III total score change <3 points
Proportion of patients whose total score of MDS-UPDRS Ⅱ+Ⅲ changed from baseline by less than 3 points
Time frame: 24 weeks
Movement Disorder Society Unified Parkinson's Disease Rating Scale(MDS-UPDRS) part Ⅰ
Assessment of non-motor symptoms of daily life.There are 13 questions, 6 questions in Part 1 A to be completed by the rater and 7 questions in Part 1 B to be completed by the patient.
Time frame: 12 weeks and 24 weeks
Cleveland Constipation Score（ CCS），Rome Ⅲ Diagnostic Criteria for Constipation
Constipation improvement was assessed using the Cleveland Constipation Score Change, an 8-question scale with scores ranging from 0 to 30. Evaluate the improvement rate of constipation according to the changes in the proportion of patients who meet the Rome III constipation diagnostic criteria
Time frame: 12 weeks and 24 weeks
Parkinson's Disease Sleep Scale-2 (PDSS-2):
Use Parkinson's Disease Sleep Scale-2 (PDSS-2) to assess the patient's sleep improvement. The scale has 15 questions，the higher the score, the worse the sleep.
Time frame: 12 weeks and 24 weeks
Clinical Global Impression-severity of illness
Change in scale scores from baseline to assess change in severity of patient's condition
Time frame: 12 weeks and 24 weeks
Clinical Global Impression-global improvement
Evaluate the efficacy of patients based on their current condition compared to the time of enrollment
Time frame: 12 weeks and 24 weeks
Long-term medication safety
Compare the incidence of adverse reactions between the two groups
Time frame: 12 weeks and 24 weeks
Plan to share: No
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Beijing Friendship Hospital