Microbiota Transplant for PAH

GP
TT
Overseen ByThenappan Thenappan, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Minnesota

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for pulmonary arterial hypertension (PAH), a condition that causes high blood pressure in the lungs. It tests the safety and practicality of microbiota transplant therapy (MTT) delivered in capsules, combined with antibiotics and fiber supplements, against a placebo. Participants will be divided into three groups to determine which combination might benefit PAH. Individuals diagnosed with PAH and on stable treatment may be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Microbiota Transplant Therapy (MTT) is safe and feasible for people with pulmonary arterial hypertension (PAH). Studies have found that MTT, which uses healthy bacteria from a donor's gut, does not cause serious side effects. Specifically, patients demonstrated improvements in the six-minute walk test, indicating they tolerated the treatment well. MTT has also been safely used for other conditions, such as Clostridioides difficile colitis, and in individuals with weakened immune systems. These findings support the safety of MTT for treating PAH.12345

Why are researchers excited about this trial's treatments?

Most treatments for pulmonary arterial hypertension (PAH) focus on dilating blood vessels or reducing blood pressure. However, the Microbiota Transplant Therapy (MTT) takes a different approach by targeting the gut microbiome. By using microbiota transplants, researchers hope to modify gut bacteria to improve overall health and potentially affect the cardiovascular system. This innovative method is exciting because it explores an entirely new pathway for managing PAH, moving beyond conventional drug treatments like endothelin receptor antagonists or phosphodiesterase inhibitors.

What evidence suggests that this trial's treatments could be effective for PAH?

Research has shown that Microbiota Transplant Therapy (MTT) might be a promising treatment for pulmonary arterial hypertension (PAH). In this trial, participants in the Drug Group will receive MTT with antibiotic preconditioning and fiber supplementation. Studies have found that even though only a small amount of donor bacteria remain in patients, MTT can still lower inflammation, which is believed to contribute to PAH. This decrease in inflammation, even if temporary, is encouraging. Previous research confirms that MTT is safe and feasible for people with PAH. These findings suggest that MTT might help manage PAH symptoms by influencing the gut microbiome, the community of tiny organisms living in the intestines.12345

Who Is on the Research Team?

LT

Levi Teigen, MD, PhD

Principal Investigator

University of Minnesota

TT

Thenappan Thenappan, MD

Principal Investigator

University of Minnesota

CS

Christopher Staley, PhD

Principal Investigator

University of Minnesota

AK

Alexander Khoruts, MD

Principal Investigator

University of Minnesota

EW

Edward Weirs, MD

Principal Investigator

University of Minnesota

KP

Kurt Prins, MD,PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with pulmonary arterial hypertension (PAH). Participants should be able to take oral medications and complete study visits. People with certain medical conditions or who can't safely participate, as determined by the study team, will not be included.

Inclusion Criteria

Provision of signed and dated consent form
Able to swallow capsules
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
See 4 more

Exclusion Criteria

I have trouble swallowing pills.
Patients with neutropenia defined as absolute neutrophil count less than 0.5 x 10^9 cells/L
Life expectancy of less than 6 months
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive microbiota transplant therapy (MTT) with antibiotic preconditioning and fiber supplementation or placebo

12 weeks
Visits at week 1, week 2, week 4, and week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
Visit at week 24

What Are the Treatments Tested in This Trial?

Interventions

  • Microbiota Transplant Therapy (MTT)

Trial Overview

The trial tests if a gut microbiota transplant in capsule form, given after antibiotics and with or without fiber supplements, is safe and feasible for PAH patients compared to placebo. Patients are randomly assigned to one of three groups.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Drug GroupExperimental Treatment1 Intervention
Group II: Control 1Active Control1 Intervention
Group III: Control 2Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Citations

Microbiota Transplant Therapy Is Safe and Feasible in ...

The MTT regimen achieves only modest levels of donor microbiota engraftment but is accompanied by a transient reduction in circulating pro-inflammatory ...

NCT06481852 | A Pilot Study of Microbiota Transplant With ...

This pilot clinical trial will evaluate the initial safety, feasibility, and pharmacokinetics of microbiota transplant therapy (MTT) with pulmonary arterial ...

Microbiota Transplant Therapy Is Safe and Feasible in ...

MTT was found to be safe and feasible in patients with PAH. Despite only modest donor bacterial engraftment (18%), MTT led to a transient ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40803054/

Microbiota Transplant Therapy Is Safe and Feasible ... - PubMed

These findings of decreased systemic inflammation with only modest donor engraftment support the potential of MTT as a novel treatment for PAH. (Microbiota ...

Microbiota Transplant Therapy Is Safe and Feasible in ...

MTT was found to be safe and feasible in patients with PAH. Despite only modest donor bacterial engraftment (18%), MTT led to a transient relative reduction in ...