Clareo Health | A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
On stable treatment for PAH for one month prior to enrollment
Able to swallow capsules
Able to provide blood sample and fecal sample
Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and/or video visits or correspondence.
You may not be if
Dysphagia to pills
Clinically active inflammatory bowel disease
Pregnancy or breastfeeding. A pregnancy test will be obtained from females of child- bearing potential at the screening visit or day 1 (prior to the receipt of MTT). Patients with a positive pregnancy test will be excluded. A negative result will be required for subjects who are females of child-bearing potential to receive MTT. Patients will be counseled to avoid pregnancy which is the standard of care for patients with PAH.
Life expectancy of \< 6 months
Presence of ileostomy or colostomy
Patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg/day, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors).
Patients with neutropenia (an absolute neutrophil count \< 0.5 x 10 9 cells/L) obtained on a complete blood count with differential at screening
History of solid organ or bone marrow transplant
Anticipated recurrent antibiotic use (patients with frequent urinary tract infections or sinusitis)
History of severe anaphylactic food allergy
History of celiac disease
Patients receiving cancer chemotherapy, immunotherapy, or radiation
Patients with severe Irritable bowel syndrome (IBS) defined by an IBS score \>250