Observations of gut microbiome changes and clinical treatments of Korean medicine in Parkinson’s disease patients with constipation: an observational single-center pilot study

Not Applicable

• Conditions: Diseases of the nervous system

• Registration Number: KCT0005744
• Lead Sponsor: Kyung Hee University Oriental Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 January 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age = 19 years
2. Patients diagnosed with Parkinson's disease according to the UK Brain Bank Criteria and whose onset age is 50 years or older
3. Patients who have no problem with cognitive function and communication, and who voluntarily agreed to participate in the present study through written consent
4. Patients who are diagnosed with functional constipation according to ROME III functional constipation diagnostic criteria

Exclusion Criteria

1. If there is an active gastrointestinal disease (e.g., celiac disease, pernicious anemia, autoimmune gastritis, symptomatic diverticulosis, inflammatory bowel disease, irritable bowel syndrome, strictures, adhesions, varicosis or diverticulum of the esophagus, Meckel's diverticulum, etc. ). However, participation is permitted for chronic gastritis
2. Patients with a history of serious heart disease such as myocardial infarction or severe heart failure (New York Heart Association classification (NYHA) Class III or higher)
3. Patients diagnosed or treated for cancer within 6 months
4. Patients with a history of chronic alcohol or substance abuse
5. Patients diagnosed with dementia or whose MMSE < 24
6. Patients with mental illness (eg, autism spectrum, schizophrenia, etc.)
7. Patients with unstable vital signs (eg, systolic blood pressure greater than 160mmHg even while taking hypertension medication)
8. Patients diagnosed with HIV
9. Patients with a family history of Parkinson's disease
10. Patients with atypical or secondary Parkinson's syndrome
11. Patients diagnosed with degenerative brain diseases other than Parkinson's disease (eg Alzheimer's type dementia)
12. Patients with other brain diseases (eg, brain tumor, traumatic brain injury, etc.)
13. Patients diagnosed with other cerebrovascular abnormalities (cerebral hemorrhage, subarachnoid hemorrhage, cerebral aneurysm, arteriovenous malformation, moyamoya disease, etc.)
14. When the researchers determine that participation in the the present study is not suitable based on medical findings, etc.

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in gut microbiome distribution

Secondary Outcome Measures

Name	Time	Method
Changes in Parkinson's Disease Rating Scales (MDS-Unified Parkinson's Disease Rating Scale, modified Hoehn & Yahr Stage, Schwab & England ADL score, Non-Motor Symptoms Scale for Parkinson's Disease);Changes in constipation symptoms (Bristol score, Wexner score);Changes in gut microbiome distribution, Parkinson's Disease Rating Scales according to the type of Parkinson’s disease;Changes in gut microbiome distribution, Parkinson's Disease Rating Scales according to the type of pattern identification (Heat, Cold);Details of treatment(Types, frequencies, durations of herbal medicines and acupuncture treatments);Analysis of factors influencing changes in specific gut microbiome