Role of the Gut Microbiome in Pulmonary Hypertension
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 16-001964
Sponsor Protocol Number: 16-001964
About this study
Pulmonary hypertension (PH) is a progressive, symptomatic, and ultimately fatal disorder for which there are no effective therapies. Resident gut microbiota are now recognized as potent modifiers of the host immune responses in various pathologies. Evidence from animal studies suggest that the microbial composition is altered in lung diseases such as asthma, chronic obstructive pulmonary disorders (COPD) and cystic fibrosis. Our goal in this study will be to determine and compare the gut microbial composition between healthy individuals and pulmonary hypertensive patients.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria - for Control Subjects:
- Age ≥ 18 years old.
- Individual is competent and willing to provide consent.
- No diagnosis of PH or other lung disease.
Inclusion Criteria - for Subjects with Pulmonary Hypertension:
- Right heart catheterization demonstrating mean pulmonary artery pressure ≥ 25 mm Hg, pulmonary artery occlusion pressure (PAOP) or left ventricular end-diastolic pressure (LVEDP) ≤ 15 mm Hg, and PVR ≥ 3 Wood units. PAOP value will be ignored if LVEDP is available.
- PAH as defined by the 2008 WHO Group I Classification (Dana Point), but excluding pulmonary capillary hemangiomatosis and pulmonary veno-occlusive disease.
- Clinical suspicion of PAH based on Echocardiogram.
- Age ≥ 18 years old.
- Individual is competent and willing to provide consent.
Exclusion Criteria:
- Age < 18 or > 90 years old.
- Left ventricular ejection fraction < 40% by echocardiography or multiple gated acquisition (MUGA) scan.
- Presence of significant diastolic dysfunction.
- Currently pregnant or have been pregnant in the last 6 months.
- Antibiotic treatment within 2 months of study enrollment.
- Currently taking a medication (e.g., antibiotic, anti-inflammatory agents, glucocorticoids or other immune modulating medications).
- Unwilling to discontinue for at least 2 weeks prior to stool collection, taking probiotic supplements that can potentially affect gut microbiota.
- History of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other malabsorption disorder.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Brian Shapiro, M.D., M.A. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available