Sikkerheten til BB-12 tilsatt jordbæryoghurt for friske voksne på antibiotika (PHASE)
17. mai 2013 oppdatert av: Daniel Merenstein, Georgetown University
Vi tror en lett tilgjengelig drikk som inneholder en høy dose probiotika har potensial til å forbedre etterlevelsen gjennom mange av disse mekanismene. Dette produktet har også potensial til å påvirke helsen til barn og voksne over hele verden positivt, ettersom yoghurt sannsynligvis vil være mer tiltalende for både barn og deres foreldre for langsiktig forbruk enn farmasøytisk-lignende preparater. I tillegg til fordelene forbundet med inntak av probiotika, er det en økt helsegevinst ved å innta yoghurt, en næringstett matvare.
Mer spesifikt, begrunnelsen for denne fase I-studien er å bestemme sikkerheten til drikken vår og overholde FDAs anbefalinger knyttet til en IND-applikasjon, vi vil gjennomføre en fase I-sikkerhetsstudie.
Vi antar at BB-12 er trygt hos friske voksne i alderen 18 år og over.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
District of Columbia
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Washington, District of Columbia, Forente stater, 20007
- Georgetown University Medical Center
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inklusjonskriterier:
- Evne til å snakke og skrive engelsk eller spansk
- Kjøleskap for riktig oppbevaring av drikke
- Telefontilgang
- Påmelding må skje innen 24 timer etter oppstart av antibiotika
- Behandling med en penicillinklasse antibiotikakur i 10 dager for en øvre luftveisinfeksjon;
Følgende er en liste over inkluderende antibiotika:
- Amoksicillin
- Augmentin (amoxicillin/klavulanat)
- Ancef (cefazolin)
- Cefadroxil
- Cephalexin
- Cephradine
- Duricef (cefadroxil)
- Keflex (cephalexin)
- Kefzol (cefazolin)
- Velosef (cephradine)
- Ceclor (cefaclor)
- Cefotan
- Cefoxitin
- Ceftin (cefuroksim)
- Cefzil (cefprozil)
- Lorabid (loracarbef)
- Mefoxin (Cefoxitin)
- Zinacef (cefuroksim)
- Omnicef (cefdinir)
- Suprax (cefixime)
- Dikloxacillin
Pen-Vee K (penicillin)
- Antibiotika foreskrevet minst to ganger om dagen
- Polikliniske pasienter
Ekskluderingskriterier:
- Kroniske tilstander, som diabetes eller astma, som krever daglig medisinering
- Allergi mot jordbær
- Aktiv diaré
- Allergi mot antibiotika i penicillinklassen
- Alle andre legemidler som brukes unntatt foreskrevne antibiotika og febernedsettende legemidler
Allergi mot noen av følgende medisiner
- Tetracyklin
- Erytromycin
- Trimetoprim
- Ciprofloksacin
- Laktoseintoleranse.
- Under grunnleggende fysisk undersøkelse vil noe av følgende være grunnlag for ekskludering; systolisk blodtrykk >140, systolisk blodtrykk <90, diastolisk >90, oksygenmetning <98 %, puls >100, puls <55 og respirasjonsfrekvens >17. Disse inkluderer alle vitale tegn som faller utenfor det "normale" området, inkludert grad 1 til grad 4.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 1. Aktiv
Bifidobacterium animalis subsp. lactis (B. lactis) stamme BB-12 (BB-12) Probiotisk, BB-12, tilsatt yoghurt, 4 gram tatt oralt i 10 dager |
Bifidobacterium animalis subsp.
lactis (B.
lactis) stamme BB-12 (BB-12) probiotisk supplert yoghurt, 4 gram tatt oralt i 10 dager
Andre navn:
|
|
Placebo komparator: 2. Placebo
Yoghurt med jordbærsmak
|
Yoghurt med jordbærsmak
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Det primære resultatet er å vurdere sikkerheten til BB-12-yoghurt når den konsumeres av generelt friske voksne som bruker antibiotika.
Tidsramme: 1 år
|
1 år
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
I tillegg til sikkerhetsdagbok, vil deltakerne føre en daglig dagbok for å spore antall avføringer, om drikke ble konsumert, hvis sykdom resulterte i endring i aktivitet, reseptfrie medisiner brukt og andre sykdomssymptomer.
Tidsramme: 1 år
|
1 år
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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- Link-Amster H, Rochat F, Saudan KY, Mignot O, Aeschlimann JM. Modulation of a specific humoral immune response and changes in intestinal flora mediated through fermented milk intake. FEMS Immunol Med Microbiol. 1994 Nov;10(1):55-63. doi: 10.1111/j.1574-695X.1994.tb00011.x. Erratum In: FEMS Immunol Med Microbiol 1995 Dec;12(3-4):273. FEMS Immunol Med Microbiol 1995 Sep;12(1):83.
- Kankaanpaa P, Sutas Y, Salminen S, Isolauri E. Results on clinical demonstration of probiotics on children. Paper presented at: Presented at Functional Food Research in Europe, Third Workshop, 1998; Probdemo, Finland, October 1-2.
- Amrouche T, Boutin Y, Fliss I. Effects of bifidobacterial cytoplasm peptide and protein fractions on mouse lymphocyte proliferation and cytokine production. Food and Agricultural Immunology. MAR 2006;17(1):29-42.
- Amrouche T, Boutin Y, Prioult G, Fliss I. Effects of bifidobacterial cytoplasm, cell wall and exopolysaccharide on mouse lymphocyte proliferation and cytokine production. International Dairy Journal. JAN 2006;16(1):70-80.
- Matsumoto M, Ohishi H, Benno Y. Impact of LKM512 yogurt on improvement of intestinal environment of the elderly. FEMS Immunol Med Microbiol. 2001 Oct;31(3):181-6. doi: 10.1111/j.1574-695X.2001.tb00518.x.
- Obradovic D, Curic M, Ivanovic M, Trbojevic B, Djordjevic M. Probiotic function of the fermented milk Jogurt Plus. Paper presented at: FEMS Conference (Fifthe Symposium on Lactic Acid Bacteria), 1996; Holland. September 8-12.
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- Nevins TE.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2009
Primær fullføring (Faktiske)
1. juli 2011
Studiet fullført (Faktiske)
1. juli 2011
Datoer for studieregistrering
Først innsendt
18. februar 2009
Først innsendt som oppfylte QC-kriteriene
19. februar 2009
Først lagt ut (Anslag)
20. februar 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. mai 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. mai 2013
Sist bekreftet
1. mai 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- R21AT003600-01A1
- IND # 13691 (Annen identifikator: FDA)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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