Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in PAH.
10. august 2026 opdateret af: University of Minnesota
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH).
This pilot clinical trial analysis 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
24
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Gretchen Peichel
- Telefonnummer: 6126266237
- E-mail: gpeichel@umn.edu
Undersøgelse Kontakt Backup
- Navn: Thenappan Thenappan, MD
- Telefonnummer: 6126261370
- E-mail: tthenapp@umn.edu
Studiesteder
-
-
Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55414
- University of Minnesota
-
Kontakt:
- Gretchen Peichel
- Telefonnummer: 612-626-6237
- E-mail: gpeichel@umn.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Kontrol 1
MTT med antibiotisk prækonditionering + placebotilskud
|
MTT vil i en kapselform sammensat af frysetørret, indkapslet tarmmikrobiota fra raske donorer.
Patienterne vil blive fulgt i uge 1, uge 2, uge 4, uge 12 og uge 24.
Patienten skal gennemgå afføringsprøve ved baseline, uge 1, uge 4 og uge 12, blodprøvetagning ved baseline, uge 4 og uge 12. Derudover vil patienten gennemgå et ekkokardiogram, seks minutters gangtest (6MWT). og livskvalitetsspørgeskema ved baseline og i uge 12.
|
|
Placebo komparator: Kontrol 2
placebo + placebotilskud.
|
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.
|
|
Eksperimentel: Drug Group
PAH patients randomized to MTT with antibiotic preconditioning + fiber supplementation
|
MTT vil i en kapselform sammensat af frysetørret, indkapslet tarmmikrobiota fra raske donorer.
Fibertilskud vil være 10-14 g oralt fibertilskud.
Patienterne vil blive fulgt i uge 1, uge 2, uge 4, uge 12 og uge 24.
Patienten skal gennemgå afføringsprøve ved baseline, uge 1, uge 4 og uge 12, blodprøvetagning ved baseline, uge 4 og uge 12. Derudover vil patienten gennemgå et ekkokardiogram, seks minutters gangtest (6MWT). og livskvalitetsspørgeskema ved baseline og i uge 12.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Donor engraftment comparison
Tidsramme: Week 12
|
The difference in donor microbiota engraftment between the three study groups at week 12
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Week 12
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Safety of MTT with antibiotic preconditioning and fiber supplementation in patients with PAH
Tidsramme: Week 12
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The difference in frequency of serious adverse events and other adverse events between the three study groups
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Week 12
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Feasibility of MTT with antibiotic preconditioning and fiber supplementation in patients with PAH
Tidsramme: Week 12
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The differences in proportion of subjects taking 100% of the MTT per protocol between the three study groups
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Week 12
|
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Change in inflammatory markers
Tidsramme: From Baseline to Week 12
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The differences in the change in circulating markers of inflammation (serum CRP and cytokine levels) and microbial metabolites (short chain fatty acids, secondary bile acids, and trimethylamine oxide) from baseline to week 12 between the three study groups.
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From Baseline to Week 12
|
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Compare right ventricular function, measure 1
Tidsramme: Week 12
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The differences in the change in six-minute walk distance (6MWD) from baseline to week 12 between the three study groups
|
Week 12
|
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Compare right ventricular function
Tidsramme: Week 12
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The differences in the change in right ventricular ejection fraction from baseline to week 12 between the three study groups
|
Week 12
|
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Compare right ventricular function
Tidsramme: Week 12
|
The differences in the change in quality of life survey from baseline to week 12 between the three study groups
|
Week 12
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Thenappan Thenappan, MD, University of Minnesota
- Ledende efterforsker: Alexander Khoruts, MD, University of Minnesota
- Ledende efterforsker: Levi Teigen, MD, PhD, University of Minnesota
- Ledende efterforsker: Christopher Staley, PhD, University of Minnesota
- Ledende efterforsker: Kurt Prins, MD,PhD, University of Minnesota
- Ledende efterforsker: Edward Weirs, MD, University of Minnesota
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
31. oktober 2029
Studieafslutning (Anslået)
30. april 2030
Datoer for studieregistrering
Først indsendt
30. juli 2026
Først indsendt, der opfyldte QC-kriterier
3. august 2026
Først opslået (Faktiske)
7. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CV-2024-32994-NIA
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