Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04884971
Status:
COMPLETED
Last Update Posted:
2024-02-12
First Post:
2021-05-07
Brief Title:
Microbiota Transplant Therapy for Pulmonary Arterial Hypertension Early Safety and Feasibility Study
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Microbiota Transplant Therapy for Pulmonary Arterial Hypertension Early Safety and Feasibility Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot clinical trial will evaluate the initial safety and feasibility of intestinal microbiota transplantation IMT in patients with pulmonary arterial hypertension PAH This trial will inform development of future trials in treatment of PAH Active drug in capsule form composed of freeze-dried encapsulated intestinal microbiota from healthy donors will be administered to patients with PAH This study will also allow for limited evaluation of pharmacokinetics in terms of donor microbiota engraftment and pharmacodynamics in terms of potential mechanisms It will also allow for limited evaluation of cardiac endurance and function prior to and after IMT
Detailed Description:
Pulmonary arterial hypertension PAH is a chronic disease characterized by pulmonary vascular remodeling of precapillary pulmonary arteries resulting in obstruction increased pulmonary vascular resistance right-sided cardiac failure and ultimately death Although pharmacologic therapies have been developed these modestly improve cardiac function and primarily act to improve symptoms and quality of life therefore PAH remains a very lethal disease Perivascular lung inflammation drives these vascular changes in PAH This inflammatory profile could be driven by an imbalance of pro- and anti-inflammatory intestinal microbial metabolites cytokines other mediators andor direct effects of circulating bacteria all stemming from dysbiosis gut-barrier dysfunction and possibly decreased hepatic filtration Because PAH is characterized by a microbiome distinct from healthy controls the investigators hypothesize that intestinal microbiota transplant IMT will help to reduce severity of PAH and improve quality of life and that the healthy microbiome may exert these effects by decreasing inflammation In this pilot clinical trial the investigators aim to test the safety and feasibility of IMT from healthy donors into patients with PAH Additionally in the exploratory objectives the investigators will obtain limited data to study pharmacokinetics of IMT including engraftment and stability of donor intestinal microbiota and pharmacodynamics to include circulating microbial products and markers of inflammation Proposed circulating markers that may be assessed include interleukin-6 C-reactive protein soluble CD14 lipopolysaccharide LPS phenylacetylglutamine trimethylamine N-oxide intestinal fatty acid binding protein zonulin claudin short-chain fatty acids SCFAs tumor necrosis factor-α interleukin-1β and transforming growth factor-β
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None