NCT04884971CompletedPhase 1
Microbiota Transplant Therapy for Pulmonary Arterial Hypertension: Early Safety and Feasibility Study
Source: ClinicalTrials.gov · Last updated 12 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 11 (actual)
- First submitted
- 7 May 2021
- Start date
- 3 Nov 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- University of Minnesota
- NCT number
- NCT04884971
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 11
- From 3 Nov 2021 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking immunosuppressants (calcineurin inhibitors, prednisone greater than or equal to 20mg/day, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors)
- History of receiving cancer chemotherapy, immunotherapy, or radiation
Other illness
- Clinically active inflammatory bowel disease
- History of solid organ or bone marrow transplant
- Anticipated recurrent antibiotic use (participants with frequent urinary tract infections or sinusitis)
- History of severe anaphylactic food allergy
- History of celiac disease
Lab values
- Neurotropenia (an absolute neurotrophil count \< 0.5 x 10\^9 cells/L)
Other
- Dysphagia to pills
- Pregnancy or breastfeeding
- Life expectancy of \<6 months
- Presence of ileostomy or colostomy
Who the study is looking for
- Diagnosis of pulmonary arterial hypertension (PAH)
- On stable treatment for PAH for one month prior to enrollment
- Able to swallow capsultes
- Able to provide blood sample and fecal sample
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.