Parkinson DiseasePhase 4NCT04871464
Role and Mechanism of Probiotics in Improving Motor Symptoms in Mild to Moderate Parkinson's Disease
A Phase 4 study testing Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules in people with Parkinson Disease and Parkinsonian Disorders, run by Beijing Friendship Hospital at 10 sites in China.
Trial 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 constipation and sleep in mild to moderate Parkinson's disease and the safety of the study; 2. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases
- What is being tested?
- Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 10 sitesChina
- Study dates
- 11 Nov 2021to Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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；
Show all 14Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites, 10 recruiting
- Not yet recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Miao Jin, PhD
- Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Zhaoxia Wang, PhD, +86 13681495953, drwangzx@163.com
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Houzhen Tuo, PhD, +8613683628005, tuohouzhen@ccmu.edu.cn
- Not yet recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Tao Feng, PhD, happyft@sina.com
- Not yet recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Biao Chen, PhD, pbchan06@hotmail.com
- Not yet recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Weizhong Xiao, PhD, xiguataoxiao@sina.com
- Not yet recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100730
Haibo Chen, PhD, 13910622285, chenhbneuro@263.net
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Han Wang, PhD, wanghanpumch@163.com
- Not yet recruiting
Jinan Central Hospital
Jinan, Shandong, 250013
Shuang Liu, PhD
- Not yet recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Hua Peng, PhD, Penghua106@163.com
About this study
Official title: Role and Mechanism of Bifidobacterium Triple Viable Capsules in Improving Motor Symptoms in Patients With Mild to Moderate Parkinson's Disease: a Multicenter Randomized Clinical Study
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.
Read the 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 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.
- Conditions
- Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Movement Disorders, Neurodegenerative Diseases
- Being tested
- Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules, Placebo
- Keywords
- Parkinson's disease, Probiotics
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Movement Disorders, Neurodegenerative Diseases, Central Nervous System Diseases, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Combined Bifidobacterium,Lactobacillus and Enterococcus CapsulesDrug
Also called BIFICO
Oral
PlaceboOther
Oral
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | 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. Receives: Drug: Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules |
| Placebo | Placebo comparator | Placebo，day 1-14, 2 capsules twice daily; Day 15-24 weeks, 4 capsules twice daily, taken orally half an hour after meals. Receives: Other: Placebo |
| Healthy control | No intervention | Healthy subjects without constipation matched for age and sex to PD subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (9)
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 12 weeks and 24 weeks
Long-term medication safety
Compare the incidence of adverse reactions between the two groups
Measured: 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start11 Nov 2021
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Houzhen Tuo, Beijing Friendship Hospital
- Investigators
- Houzhen Tuo, PhD, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871464
- Sponsor's protocol ID
- 2019-P2-153-02
- Status last verified
- Feb 2023
- First submitted
- 29 Apr 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sampson TR, Debelius JW, Thron T, Janssen S, Shastri GG, Ilhan ZE, Challis C, Schretter CE, Rocha S, Gradinaru V, Chesselet MF, Keshavarzian A, Shannon KM, Krajmalnik-Brown R, Wittung-Stafshede P, Knight R, Mazmanian SK. Gut Microbiota Regulate Motor Deficits and Neuroinflammation in a Model of Parkinson's Disease. Cell. 2016 Dec 1;167(6):1469-1480.e12. doi: 10.1016/j.cell.2016.11.018.
PubMed 27912057Barichella M, Pacchetti C, Bolliri C, Cassani E, Iorio L, Pusani C, Pinelli G, Privitera G, Cesari I, Faierman SA, Caccialanza R, Pezzoli G, Cereda E. Probiotics and prebiotic fiber for constipation associated with Parkinson disease: An RCT. Neurology. 2016 Sep 20;87(12):1274-80. doi: 10.1212/WNL.0000000000003127. Epub 2016 Aug 19.
PubMed 27543643Tamtaji OR, Taghizadeh M, Daneshvar Kakhaki R, Kouchaki E, Bahmani F, Borzabadi S, Oryan S, Mafi A, Asemi Z. Clinical and metabolic response to probiotic administration in people with Parkinson's disease: A randomized, double-blind, placebo-controlled trial. Clin Nutr. 2019 Jun;38(3):1031-1035. doi: 10.1016/j.clnu.2018.05.018. Epub 2018 Jun 1.
PubMed 29891223Kim S, Kwon SH, Kam TI, Panicker N, Karuppagounder SS, Lee S, Lee JH, Kim WR, Kook M, Foss CA, Shen C, Lee H, Kulkarni S, Pasricha PJ, Lee G, Pomper MG, Dawson VL, Dawson TM, Ko HS. Transneuronal Propagation of Pathologic alpha-Synuclein from the Gut to the Brain Models Parkinson's Disease. Neuron. 2019 Aug 21;103(4):627-641.e7. doi: 10.1016/j.neuron.2019.05.035. Epub 2019 Jun 26.
PubMed 31255487Qian Y, Yang X, Xu S, Wu C, Song Y, Qin N, Chen SD, Xiao Q. Alteration of the fecal microbiota in Chinese patients with Parkinson's disease. Brain Behav Immun. 2018 May;70:194-202. doi: 10.1016/j.bbi.2018.02.016. Epub 2018 Mar 2.
PubMed 29501802Scheperjans F, Aho V, Pereira PA, Koskinen K, Paulin L, Pekkonen E, Haapaniemi E, Kaakkola S, Eerola-Rautio J, Pohja M, Kinnunen E, Murros K, Auvinen P. Gut microbiota are related to Parkinson's disease and clinical phenotype. Mov Disord. 2015 Mar;30(3):350-8. doi: 10.1002/mds.26069. Epub 2014 Dec 5.
PubMed 25476529
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role and Mechanism of Bifidobacterium Triple Viable Capsules in Improving Motor Symptoms in Patients With Mild to Moderate Parkinson's Disease: a Multicenter Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT04871464
- Acronym / sponsor ID
- 2019-P2-153-02
- Conditions
- Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Movement Disorders, Neurodegenerative Diseases
- Keywords
- Parkinson's disease, Probiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Drug: Live Combined Bifidobacterium,Lactobacillus and Enterococcus CapsulesBifidobacterium 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. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo，day 1-14, 2 capsules twice daily; Day 15-24 weeks, 4 capsules twice daily, taken orally half an hour after meals. |
| Healthy control | No intervention | –Healthy subjects without constipation matched for age and sex to PD subjects |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live Combined Bifidobacterium,Lactobacillus and Enterococcus CapsulesAlso: BIFICOOral | Drug | Probiotics |
| PlaceboOral | Other | Placebo |
Primary outcome
Movement Disorder Society Unified Parkinson's Disease Rating Scale(MDS-UPDRS)Ⅱ+Ⅲ
Time frame: 12 weeks
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.
9 secondary outcomes
Proportion of MDS-UPDRS II+III total score change <3 points
Time frame: 12 weeks
Movement Disorder Society Unified Parkinson's Disease Rating Scale(MDS-UPDRS)Ⅱ+Ⅲ
Time frame: 24 weeks
Proportion of MDS-UPDRS II+III total score change <3 points
Time frame: 24 weeks
Movement Disorder Society Unified Parkinson's Disease Rating Scale(MDS-UPDRS) part Ⅰ
Time frame: 12 weeks and 24 weeks
Cleveland Constipation Score（ CCS），Rome Ⅲ Diagnostic Criteria for Constipation
Time frame: 12 weeks and 24 weeks
Parkinson's Disease Sleep Scale-2 (PDSS-2):
Time frame: 12 weeks and 24 weeks
Clinical Global Impression-severity of illness
Time frame: 12 weeks and 24 weeks
Clinical Global Impression-global improvement
Time frame: 12 weeks and 24 weeks
Long-term medication safety
Time frame: 12 weeks and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Background: PubMed 27912057Sampson TR, Debelius JW, Thron T, Janssen S, Shastri GG, Ilhan ZE, Challis C, Schretter CE, Rocha S, Gradinaru V, Chesselet MF, Keshavarzian A, Shannon KM, Krajmalnik-Brown R, Wittung-Stafshede P, Knight R, Mazmanian SK. Gut Microbiota Regulate Motor Deficits and Neuroinflammation in a Model of Parkinson's Disease. Cell. 2016 Dec 1;167(6):1469-1480.e12. doi: 10.1016/j.cell.2016.11.018.
- Background: PubMed 27543643Barichella M, Pacchetti C, Bolliri C, Cassani E, Iorio L, Pusani C, Pinelli G, Privitera G, Cesari I, Faierman SA, Caccialanza R, Pezzoli G, Cereda E. Probiotics and prebiotic fiber for constipation associated with Parkinson disease: An RCT. Neurology. 2016 Sep 20;87(12):1274-80. doi: 10.1212/WNL.0000000000003127. Epub 2016 Aug 19.
- Background: PubMed 29891223Tamtaji OR, Taghizadeh M, Daneshvar Kakhaki R, Kouchaki E, Bahmani F, Borzabadi S, Oryan S, Mafi A, Asemi Z. Clinical and metabolic response to probiotic administration in people with Parkinson's disease: A randomized, double-blind, placebo-controlled trial. Clin Nutr. 2019 Jun;38(3):1031-1035. doi: 10.1016/j.clnu.2018.05.018. Epub 2018 Jun 1.
- Background: PubMed 31255487Kim S, Kwon SH, Kam TI, Panicker N, Karuppagounder SS, Lee S, Lee JH, Kim WR, Kook M, Foss CA, Shen C, Lee H, Kulkarni S, Pasricha PJ, Lee G, Pomper MG, Dawson VL, Dawson TM, Ko HS. Transneuronal Propagation of Pathologic alpha-Synuclein from the Gut to the Brain Models Parkinson's Disease. Neuron. 2019 Aug 21;103(4):627-641.e7. doi: 10.1016/j.neuron.2019.05.035. Epub 2019 Jun 26.
- Background: PubMed 29501802Qian Y, Yang X, Xu S, Wu C, Song Y, Qin N, Chen SD, Xiao Q. Alteration of the fecal microbiota in Chinese patients with Parkinson's disease. Brain Behav Immun. 2018 May;70:194-202. doi: 10.1016/j.bbi.2018.02.016. Epub 2018 Mar 2.
- Background: PubMed 25476529Scheperjans F, Aho V, Pereira PA, Koskinen K, Paulin L, Pekkonen E, Haapaniemi E, Kaakkola S, Eerola-Rautio J, Pohja M, Kinnunen E, Murros K, Auvinen P. Gut microbiota are related to Parkinson's disease and clinical phenotype. Mov Disord. 2015 Mar;30(3):350-8. doi: 10.1002/mds.26069. Epub 2014 Dec 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Houzhen Tuo, PhD principal investigator
Beijing Friendship Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules in people with Parkinson Disease and Parkinsonian Disorders, run by Beijing Friendship Hospital at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Houzhen Tuo, PhD (+8613683628005 ext. 13810468301, tuohouzhen@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Disorder Society Unified Parkinson's Disease Rating Scale(MDS-UPDRS)Ⅱ+Ⅲ (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04871464, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.