Rifaximin til sekundær forebyggelse af tilbagevendende pouchitis
8. juli 2025 opdateret af: University of North Carolina, Chapel Hill
Selvom mange mennesker vil udvikle tilbagevendende pouchitis (betændelse i ileal pouch-anal anastomose eller J-pouch efter kolektomi for ulcerøs colitis) efter en indledende episode af pouchitis, er der i øjeblikket ingen effektive behandlinger til at forhindre tilbagevendende pouchitis.
Målet med denne undersøgelse er at evaluere potentialet for rifaximin, et antibiotikum, til at forhindre tilbagevendende pouchitis efter behandling for en indledende episode af pouchitis.
I denne undersøgelse vil alle patienter få daglig rifaximin i et år efter at være blevet behandlet for en indledende episode af pouchitis.
Denne undersøgelse vil undersøge, om folk er villige til at tage rifaximin i et år med det formål at forhindre tilbagevendende pouchitis.
Derudover vil denne undersøgelse undersøge, om patienter oplever nogen uventede bivirkninger af rifaximinbehandling.
Informationen opnået gennem denne undersøgelse vil potentielt være nyttig til at forbedre vores evne til at forhindre tilbagevendende pouchitis hos patienter, der har en kolektomi for colitis ulcerosa.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
16
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Mikki Sandridge
- Telefonnummer: (919) 843-3873
- E-mail: mikki_sandridge@med.unc.edu
Studiesteder
-
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New York
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New York, New York, Forenede Stater, 10016
- Rekruttering
- NYU IBD Center
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Kontakt:
- Nathasha Melukkaran
- Telefonnummer: 646-754-3417
- E-mail: Nathasha.melukkaran@nyulangone.org
-
Ledende efterforsker:
- Shannon Chang, MD, MBA
-
-
North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- Rekruttering
- University of North Carolina
-
Kontakt:
- Mikki Sandridge
- Telefonnummer: 919-843-3873
- E-mail: mikki_sandridge@med.unc.edu
-
Ledende efterforsker:
- Edward Barnes, MD, MPH
-
-
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
Inklusionskriterier:
- Informeret samtykke vil blive indhentet før eventuelle undersøgelsesrelaterede procedurer
- Alder > 18 og <75 år
- Deltagere med en dokumenteret historie med colitis ulcerosa og historie med 1,2, modificeret -2 eller 3 trins Ileal pouch anal anastomose (IPAA) og ileostomi fjernelse
- Diagnose af indledende episode af pouchitis inden for de første 12 måneder efter fjernelse af ileostomi/sidste fase af IPAA-kirurgi
Ekskluderingskriterier:
- Kendt overfølsomhed over for rifaximin eller dets metabolitter
- Kendt Crohns sygdom
- Historie om perianal fistel
- Kendt inkontinens på grund af anal sphincter dysfunktion
- Kendt irritabel posesyndrom
- Aktiv igangværende bækkeninfektion/sepsis ved baseline besøg
- Ny indtræden af høj tarmhyppighed i forbindelse med akut pouchitis i de første 4 uger efter IPAA
- Kendt Clostridoides difficile infektion
- Behov for langtidsbehandling med antibiotika (f. doxycyclin mod acne)
- Kendt aktiv Hepatitis B, C, HIV
- Klinisk signifikant leversygdom (Primær skleroserende cholangitis med LFT's <1,5 øvre normalgrænse kan inkluderes)
- Svært nedsat leverfunktion, defineret som Child-Pugh klasse C
- Samtidig brug af p-glycoprotein (P-gp) hæmmere (f. cyclosporin)
- Kendt nedsat nyrefunktion med en glomerulær filtrationshastighed <60 ml/min/1,732
- Fækal mikrobiotatransplantation inden for 16 uger før fjernelse af ileostomi
- Anamnese med malignitet, bortset fra basalcellecarcinom, ikke-metastatisk pladecellecarcinom i huden eller tidligere malignitet med kurativ behandling afsluttet mindst 5 år før screening og ingen gentagelse.
- Klinisk signifikante laboratorieresultater ved screening eller baseline, som bedømt af investigator ud fra lokal test.
- Kvinde, der er gravid, ammer eller har til hensigt at blive gravid eller er i den fødedygtige alder og ikke bruger en højeffektiv præventionsmetode. Kvinder i den fødedygtige alder skal have en negativ uringraviditetstest, før lægemidlet udleveres.
- Deltagelse i ethvert klinisk forsøg med et godkendt eller ikke-godkendt forsøgslægemiddel inden for 30 dage før screening.
- Enhver lidelse, som efter efterforskerens mening kan bringe deltagerens sikkerhed eller overholdelse af protokollen i fare.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Alle deltagere
550 mg Rifaximin (Xifaxan) to gange dagligt x 365 dage
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Rifaximin 550 MG oral tablet [XIFAXAN] Tages to gange dagligt i op til 365 dage
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Procentdel af deltagere, der udvikler tilbagevendende pouchitis
Tidsramme: 12 måneder
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Tilbagevendende pouchitis, defineret som en anden episode af pouchitis inden for en 12 måneders periode efter den første episode af pouchitis eller behovet for forlænget/tilbagevendende antibiotika efter den indledende 14-dages periode (og påbegyndelse af rifaximin).
|
12 måneder
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Edward Barnes, MD, MPH, University of North Carolina
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- Human Microbiome Project Consortium. Structure, function and diversity of the healthy human microbiome. Nature. 2012 Jun 13;486(7402):207-14. doi: 10.1038/nature11234.
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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 (Faktiske)
1. juli 2024
Primær færdiggørelse (Anslået)
1. juli 2026
Studieafslutning (Anslået)
1. juli 2026
Datoer for studieregistrering
Først indsendt
8. marts 2024
Først indsendt, der opfyldte QC-kriterier
8. marts 2024
Først opslået (Faktiske)
15. marts 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. juli 2025
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juli 2025
Sidst verificeret
1. juli 2025
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 23-2111
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JA
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IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
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Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ja
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