Microbiota transplant therapy for pulmonary arterial hypertension
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
This study is testing if a new treatment using microbiota transplant therapy can help people with pulmonary arterial hypertension feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, methotrexate, prednisone |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06481852 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial evaluates the safety, feasibility, and pharmacokinetics of microbiota transplant therapy (MTT) combined with antibiotic preconditioning and fiber supplementation in patients with pulmonary arterial hypertension (PAH). A total of 24 participants will be randomized to receive either MTT with fiber supplementation, MTT with placebo, or a placebo treatment. Patients will be monitored over a 24-week period with follow-up visits and sample collections to assess the therapy's effects. The findings will help inform future studies on MTT as a potential treatment for PAH.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 diagnosed with pulmonary arterial hypertension who are stable on treatment.
Not a fit: Patients with dysphagia, active inflammatory bowel disease, or a life expectancy of less than six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel treatment option for patients with pulmonary arterial hypertension.
How similar studies have performed: While this approach is novel, other studies exploring microbiota therapies have shown promising results in different conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of signed and dated consent form * Ages 18-75 * Diagnosis of 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. Exclusion Criteria: * 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Thenappan Thenappan, MD — University of Minnesota
- Study coordinator: Gretchen Peichel
- Email: gpeichel@umn.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.