Microbiota Transplant Therapy for Pulmonary Arterial Hypertension: Early Safety and Feasibility Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04884971 |
Recruitment Status :
Completed
First Posted : May 13, 2021
Last Update Posted : February 12, 2024
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Condition or disease | Intervention/treatment | Phase |
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Pulmonary Arterial Hypertension | Drug: Intestinal microbiota transplant (IMT) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Microbiota Transplant Therapy for Pulmonary Arterial Hypertension: Early Safety and Feasibility Study |
Actual Study Start Date : | November 3, 2021 |
Actual Primary Completion Date : | December 31, 2023 |
Actual Study Completion Date : | December 31, 2023 |
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Arm | Intervention/treatment |
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Experimental: Microbiota Treatment Arm
Participants will receive the encapsulated microbiota intervention daily for seven days and will be subsequently monitored for six months.
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Drug: Intestinal microbiota transplant (IMT)
Two size 00 capsules from a single lot will be taken daily. Approximately 2.0 x 10^11 bacteria from a healthy donor are contained in each capsule. |
- Frequency of Serious Adverse Events [ Time Frame: 6 months ]In order to assess the safety of the trial, the frequency of adverse events will be reported. Outcome will be reported as the mean number of serious adverse events per participant.
- Proportion of IMT Compliance [ Time Frame: 6 months ]In order to assess the feasibility of the trial, the proportion of subjects taking 100% of the intestinal microbiota transplantation (IMT) doses per protocol will be reported. Outcome is reported as the percent of participants who consume 100% of IMT doses.
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Dysphagia to pills
- Clinically active inflammatory bowel disease
- Pregnancy or breastfeeding
- Life expectancy of <6 months
- Presence of ileostomy or colostomy
- Taking immunosuppressants (calcineurin inhibitors, prednisone greater than or equal to 20mg/day, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors)
- Neurotropenia (an absolute neurotrophil count < 0.5 x 10^9 cells/L)
- 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
- History of receiving cancer chemotherapy, immunotherapy, or radiation
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04884971
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Thenappan Thenappan, MD | University of Minnesota Division of Cardiology | |
Principal Investigator: | Kurt Prins, MD, PhD | University of Minnesota Division of Cardiology | |
Principal Investigator: | Edward Weir, MD | University of Minnesota Division of Cardiology | |
Principal Investigator: | Alexander Khoruts, MD | University of Minnesota Division of Gastroenterology |
Responsible Party: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT04884971 |
Other Study ID Numbers: |
CV-2021-29604 |
First Posted: | May 13, 2021 Key Record Dates |
Last Update Posted: | February 12, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Pulmonary Arterial Hypertension Familial Primary Pulmonary Hypertension Hypertension Vascular Diseases |
Cardiovascular Diseases Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases |