- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03336697
Determining the Microbiota Composition of the Middle Meatus in Parkinson's
Determining the Microbiota Composition of the Middle Meatus in Parkinson's Disease
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Illinois
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Chicago, Illinois, Förenta staterna, 60612
- Rush University Medical Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- 1. Patients with a clinical diagnosis of Parkinson's disease by United Kingdom Parkinson Disease Society Brain Bank criteria will be recruited.
2. Hoehn & Yahr stage 1-3 3. Parkinson's disease symptomatic treatment will be allowed. 4. Subjects with deep brain stimulation are allowed.
Exclusion Criteria:
1. Occupation expected to change intestinal flora pattern (e.g. sanitation worker) 2. Treatment with medications that may induce parkinsonism (metoclopramide, typical, or atypical antipsychotic agents) 3. Treatment within 12 weeks with systemic antibiotics 4. Known diagnosis of inflammatory bowel disease 5. Symptomatic organic GI disease other than hemorrhoids and hiatal hernia or abdominal surgeries for symptomatic GI disease such as bowel resection, diverticular surgery, colostomy, etc (subjects with a history of an appendectomy or cholesytectomy for benign disease more than 5 years prior to presentation are allowed).
6. Symptomatic functional GI disease that significantly impairs intestinal motility such as scleroderma or use of GI motility drugs 7. Acute illness requiring immediate hospitalization 8. Pre-existent organ failure or comorbidities as these may change GI flora:
- 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;
- Clinically significant dehydration or clinically detectable ascites or peripheral edema or cardiac failure 9. Presence of short bowel syndrome or severe malnutrition with ideal body weight < or = 90% or 10. Estimated survival <1 year and Karnofsky performance status <50%; 11. Use of immunosuppressive medications within 3 months of enrollment 12. Chronic use of diuretics
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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Parkinson's disease subjects
Patients with untreated or treated Parkinson's disease ages 45-75.
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a nasal swab will be performed by a trained physician by gently passing of a cotton swab in the nasal passage to get samples from middle meatus.
This will be performed under guide of nasal anterior endoscopy to visualize the location of sampling.
The cotton swab heads will be placed in sterile tubes and frozen at -80°C until DNA extraction.
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Healthy control subjects
Healthy control subjects ages 45-75.
|
a nasal swab will be performed by a trained physician by gently passing of a cotton swab in the nasal passage to get samples from middle meatus.
This will be performed under guide of nasal anterior endoscopy to visualize the location of sampling.
The cotton swab heads will be placed in sterile tubes and frozen at -80°C until DNA extraction.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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nasal inflammatory microbiome
Tidsram: 1 year
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For microbiome analysis, in silico community functional predictions will be performed using PICRUSt (Phylogenetic Investigation of Communities by Reconstruction of Unobserved States) and significant differences in Kyoto Encyclopedia of Genes and Genomes (KEGG) ortholog (KO) abundances between groups will be identified.
"proinflammatory" and "anti-inflammatory" bacteria taxa will be classified and differences in inflammatory metabolite abundance will be compared.
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1 year
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 16111609-IRB01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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