Sikkerhed ved BB-12 suppleret jordbæryoghurt til raske voksne på antibiotika (PHASE)
17. maj 2013 opdateret af: Daniel Merenstein, Georgetown University
Vi mener, at en let tilgængelig drik, der indeholder en høj dosis probiotika, har potentialet til at forbedre compliance gennem mange af disse mekanismer. Dette produkt har også potentialet til at påvirke sundheden for børn og voksne over hele verden positivt, da yoghurt sandsynligvis vil være mere tiltalende for både børn og deres forældre til langtidsforbrug end farmaceutiske præparater. Ud over de fordele, der er forbundet med indtagelse af probiotika, er der en øget sundhedsfordel ved at indtage yoghurt, en næringsrig fødevare.
Mere specifikt, begrundelsen for dette fase I-studie er at bestemme sikkerheden af vores drik og overholde FDA's anbefalinger vedrørende en IND-ansøgning, vi vil gennemføre en fase I-sikkerhedsundersøgelse.
Vi antager, at BB-12 er sikkert hos raske voksne i alderen 18 år og derover.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
40
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
District of Columbia
-
Washington, District of Columbia, Forenede Stater, 20007
- Georgetown University Medical Center
-
-
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
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Evne til at tale og skrive engelsk eller spansk
- Køleskab til korrekt opbevaring af drikkevarer
- Telefonadgang
- Tilmelding skal ske inden for 24 timer efter start af antibiotika
- Behandling med en penicillinklasse antibiotikakur i 10 dage for en øvre luftvejsinfektion;
Følgende er en liste over inkluderende antibiotika:
- Amoxicillin
- Augmentin (amoxicillin/clavulanat)
- Ancef (cefazolin)
- Cefadroxil
- Cephalexin
- Cephradine
- Duricef (cefadroxil)
- Keflex (cephalexin)
- Kefzol (cefazolin)
- Velosef (cephradine)
- Ceclor (cefaclor)
- Cefotan
- Cefoxitin
- Ceftin (cefuroxim)
- Cefzil (cefprozil)
- Lorabid (loracarbef)
- Mefoxin (Cefoxitin)
- Zinacef (cefuroxim)
- Omnicef (cefdinir)
- Suprax (cefixime)
- Dicloxacillin
Pen-Vee K (penicillin)
- Antibiotikum ordineret mindst to gange om dagen
- Ambulante patienter
Ekskluderingskriterier:
- Kroniske tilstande, såsom diabetes eller astma, der kræver daglig medicin
- Allergi over for jordbær
- Aktiv diarré
- Allergi over for antibiotikum i penicillinklassen
- Enhver anden medicin, der anvendes, undtagen ordineret antibiotika og anti-pyretisk medicin
Allergi over for nogen af følgende lægemidler
- Tetracyclin
- Erythromycin
- Trimethoprim
- Ciprofloxacin
- Laktoseintolerance.
- Under den fysiske basisundersøgelse vil et eller flere af følgende være grund til udelukkelse; systolisk blodtryk >140, systolisk blodtryk <90, diastolisk >90, iltmætning <98 %, puls >100, puls <55 og respirationsfrekvens >17. Disse omfatter alle vitale tegn, der falder uden for det "normale" område, inklusive klasse 1 til og med grad 4.
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 1. Aktiv
Bifidobacterium animalis subsp. lactis (B. lactis) stamme BB-12 (BB-12) Probiotisk, BB-12, suppleret yoghurt, 4 ounces indtaget oralt i 10 dage |
Bifidobacterium animalis subsp.
lactis (B.
lactis) stamme BB-12 (BB-12) probiotisk suppleret yoghurt, 4 ounces indtaget oralt i 10 dage
Andre navne:
|
|
Placebo komparator: 2. Placebo
Yoghurt med jordbærsmag
|
Yoghurt med jordbærsmag
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Det primære resultat er at vurdere sikkerheden af BB-12 yoghurt, når den indtages af generelt raske voksne, der indtager antibiotika.
Tidsramme: 1 år
|
1 år
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Ud over sikkerhedsdagbog vil deltagerne føre en daglig dagbog for at spore antallet af afføringer, om der blev indtaget drikkevarer, hvis sygdom resulterede i ændring i aktivitet, brugt håndkøbsmedicin og andre sygdomssymptomer.
Tidsramme: 1 år
|
1 år
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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.
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- Nevins TE.
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
1. oktober 2009
Primær færdiggørelse (Faktiske)
1. juli 2011
Studieafslutning (Faktiske)
1. juli 2011
Datoer for studieregistrering
Først indsendt
18. februar 2009
Først indsendt, der opfyldte QC-kriterier
19. februar 2009
Først opslået (Skøn)
20. februar 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. maj 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. maj 2013
Sidst verificeret
1. maj 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- R21AT003600-01A1
- IND # 13691 (Anden identifikator: FDA)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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