Ignite Creation Date:
2024-07-17 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481852
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-24
Brief Title:
A Placebo-controlled Randomized Clinical Trial to Assess the Safety Feasibility and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
A Placebo-controlled Randomized Clinical Trial to Assess the Safety Feasibility and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension
Status:
RECRUITING
Status Verified Date:
2024-10
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 feasibility and pharmacokinetics of microbiota transplant therapy MTT with antibiotic pre-conditioning and fiber supplementation vs placebo in patients with pulmonary arterial hypertension PAH This trial will inform development of future trials of MTT as a treatment for PAH 24 PAH patients will be randomized to receive either MTT with antibiotic preconditioning fiber supplementation MTT with antibiotic preconditioning placebo supplementation or placebo placebo supplementation MTT will in a capsule form composed of freeze-dried encapsulated intestinal microbiota from healthy donors Fiber supplementation will be 10-14 gm oral fiber supplement Patients will be followed at week 1 week 2 week 4 week 12 and week 24 Patient will undergo stool sample collection at baseline week 1 week 4 and week 12 blood sample collection at baseline week 4 and week12 In addition patient will undergo an echocardiogram six-minute walk test 6MWT and quality of life questionnaire at baseline and at week 12
Detailed Description:
None
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