Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT04976959
Eligibility Criteria:
Inclusion Criteria:
* Parkinson's disease patients who are untreated
Exclusion Criteria:
* Occupation expected to change the microbiome (e.g. sanitation worker)
* Treatment with medications that may induce parkinsonism (e.g. metoclopramide, typical or atypical antipsychotic agents)
* Treatment within 12 weeks with oral or intravenous antibiotics
* Known diagnosis of inflammatory bowel disease
* Symptomatic organic gastrointestinal (GI) disease (other than hemorrhoids and hiatal hernia) or abdominal surgeries for symptomatic gastrointestinal disease such as bowel resection, diverticular surgery, colostomy; subjects with a history of an appendectomy or gallbladder removal for non-cancerous disease more than 5 years prior to presentation are allowed.
* Symptomatic functional GI disease that significantly impairs intestinal motility such as scleroderma or use of GI motility drugs
* Acute illness requiring immediate hospitalization
* Pre-existent conditions as below:
* Liver disease (cirrhosis or persistently abnormal AST or ALT that are 2X\> normal);
* Kidney disease (creatinine\>2.0 mg/dL);
* Uncontrolled psychiatric illness;
* Clinically important lung disease or heart failure;
* HIV disease;
* Alcoholism, unreliable drinking history; or consumption of alcohol more than 3 times a week or binge drinking or drinking more than or equal to 3 drinks per occasion;
* Transplant recipients;
* Diabetes;
* BMI \> 30
* Clinically significant dehydration or clinically detectable ascites or peripheral edema or cardiac failure
* Presence of short bowel syndrome or severe malnutrition with ideal body weight \< or = 90%
* Use of immunosuppressive medications in 3 months prior to enrollment
* Anti-inflammatory medication use within 3 weeks of enrollment.
* Chronic use of diuretics
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT04976959
Study Brief:
Protocol Section:
NCT04976959