Pulmonary Arterial HypertensionPhase 1NCT06481852

A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)

A Phase 1 study testing MTT with antibiotic preconditioning + fiber supplementation in people with Pulmonary Arterial Hypertension, run by University of Minnesota at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pulmonary Arterial Hypertension
What is being tested?: MTT with antibiotic preconditioning + fiber supplementation
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 28 Oct 2024to 30 Jun 2027
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Minnesota
Minneapolis, Minnesota, 55414

Other trials in United States

About this study

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 week,12. In addition, patient will undergo an echocardiogram, six-minute walk test (6MWT) and quality of life questionnaire at baseline and at week 12.

Conditions: Pulmonary Arterial Hypertension
Being tested: MTT with antibiotic preconditioning + fiber supplementation, MTT with antibiotic preconditioning + placebo supplementation, MTT with placebo + placebo supplementation.
Medical subject headings: Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MTT with antibiotic preconditioning + fiber supplementationDrug
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 week, 12. In addition, patient will undergo an echocardiogram, six-minute walk test (6MWT) and quality of life questionnaire at baseline and at week 12.
MTT with antibiotic preconditioning + placebo supplementationDrug
MTT will in a capsule form composed of freeze-dried, encapsulated intestinal microbiota from healthy donors. 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 week, 12. In addition, patient will undergo an echocardiogram, six-minute walk test (6MWT) and quality of life questionnaire at baseline and at week 12.
MTT with placebo + placebo supplementation.Other
MTT will in a capsule form composed of freeze-dried, encapsulated intestinal microbiota from healthy donors. 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 week, 12. In addition, patient will undergo an echocardiogram, six-minute walk test (6MWT) and quality of life questionnaire at baseline and at week 12.

Study groups in NCT06481852
Study group	Role	What they receive
Drug group	Experimental	PAH patients randomized to MTT with antibiotic preconditioning + fiber supplementation Receives: Drug: MTT with antibiotic preconditioning + fiber supplementation
Control 1	Active comparator	MTT with antibiotic preconditioning + placebo supplementation Receives: Drug: MTT with antibiotic preconditioning + placebo supplementation
Control 2	Placebo comparator	placebo + placebo supplementation. Receives: Other: MTT with placebo + placebo supplementation.

What is being measured

The primary outcome is the main question the study is designed to answer.

donor engraftment comparison
The difference in donor microbiota engraftment between the three study groups at week 12
Measured: week 12

Secondary outcomes (6)

safety of MTT with antibiotic preconditioning and fiber supplementation in patients with PAH
The difference in frequency of serious adverse events and other adverse events between the three study groups
Measured: week 12
feasibility of MTT with antibiotic preconditioning and fiber supplementation in patients with PAH
The differences in proportion of subjects taking 100% of the MTT per protocol between the three study groups
Measured: week 12
change in inflammatory markers
The differences in the change in circulating markers of inflammation and microbial metabolites from baseline to week 12 between the three study groups
Measured: week 12
compare right ventricular function, measure 1
The differences in the change in six-minute walk distance (6MWD) from baseline to week 12 between the three study groups
Measured: week 12
compare right ventricular function
The differences in the change in right ventricular ejection fraction from baseline to week 12 between the three study groups
Measured: week 12
compare right ventricular function
The differences in the change in quality of life survey from baseline to week 12 between the three study groups
Measured: week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 202430 Jun 2027

First posted1 Jul 2024
Study start28 Oct 2024
Primary completion30 Jun 2027 (estimated)
Study completion30 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
More trials run by University of MinnesotaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06481852
Sponsor's protocol ID: CV-2024-32994
Status last verified: Nov 2026
First submitted: 24 Jun 2024
Last updated: 6 Nov 2026
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
RecruitingPhase 4
Sotatercept in Pulmonary Arterial Hypertension
Pulmonary Artery Hypertension

All Pulmonary Arterial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
ClinicalTrials.gov ID: NCT06481852
Acronym / sponsor ID: CV-2024-32994
Conditions: Pulmonary Arterial Hypertension
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 24 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Study start: 28 Oct 2024 (actual)
Primary completion: 30 Jun 2027 (estimated)
Study completion: 30 Jun 2027 (estimated)
First posted: 1 Jul 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Drug group	Experimental	Drug: MTT with antibiotic preconditioning + fiber supplementationPAH patients randomized to MTT with antibiotic preconditioning + fiber supplementation
Control 1	Active comparator	Drug: MTT with antibiotic preconditioning + placebo supplementationMTT with antibiotic preconditioning + placebo supplementation
Control 2	Placebo comparator	Other: MTT with placebo + placebo supplementation.placebo + placebo supplementation.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MTT with antibiotic preconditioning + fiber supplementationMTT 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 week, 12. In addition, patient will undergo an echocardiogram, six-minute walk test (6MWT) and quality of life questionnaire at baseline and at week 12.	Drug	Drug group
MTT with antibiotic preconditioning + placebo supplementationMTT will in a capsule form composed of freeze-dried, encapsulated intestinal microbiota from healthy donors. 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 week, 12. In addition, patient will undergo an echocardiogram, six-minute walk test (6MWT) and quality of life questionnaire at baseline and at week 12.	Drug	Control 1
MTT with placebo + placebo supplementation.MTT will in a capsule form composed of freeze-dried, encapsulated intestinal microbiota from healthy donors. 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 week, 12. In addition, patient will undergo an echocardiogram, six-minute walk test (6MWT) and quality of life questionnaire at baseline and at week 12.	Other	Control 2

Primary outcome

donor engraftment comparison
Time frame: week 12
The difference in donor microbiota engraftment between the three study groups at week 12

6 secondary outcomes

safety of MTT with antibiotic preconditioning and fiber supplementation in patients with PAH
Time frame: week 12
feasibility of MTT with antibiotic preconditioning and fiber supplementation in patients with PAH
Time frame: week 12
change in inflammatory markers
Time frame: week 12
compare right ventricular function, measure 1
Time frame: week 12
compare right ventricular function
Time frame: week 12
compare right ventricular function
Time frame: week 12

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.

Related trials for Pulmonary Arterial Hypertension

Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
RecruitingPhase 4
Sotatercept in Pulmonary Arterial Hypertension
Pulmonary Artery Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thenappan Thenappan, MD principal investigator

University of Minnesota

Levi Teigen, MD, PhD principal investigator

University of Minnesota

Alexander Khoruts, MD principal investigator

University of Minnesota

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MTT with antibiotic preconditioning + fiber supplementation in people with Pulmonary Arterial Hypertension, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

donor engraftment comparison (time frame: week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06481852.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.