Säkerheten för BB-12 kompletterad jordgubbsyoghurt för friska vuxna på antibiotika (PHASE)
17 maj 2013 uppdaterad av: Daniel Merenstein, Georgetown University
Vi tror att en lättillgänglig dryck som innehåller en hög dos probiotika har potential att förbättra efterlevnaden genom många av dessa mekanismer. Denna produkt har också potential att positivt påverka hälsan hos barn och vuxna runt om i världen, eftersom yoghurt sannolikt kommer att vara mer tilltalande för både barn och deras föräldrar för långtidskonsumtion än läkemedelsliknande preparat. Förutom de fördelar som är förknippade med konsumtion av probiotika, finns det en ökad hälsovinst av att konsumera yoghurt, en näringsrik mat.
Mer specifikt, motiveringen för denna fas I-studie är att fastställa säkerheten för vår dryck och följa FDA:s rekommendationer för en IND-ansökan, vi kommer att genomföra en fas I-säkerhetsstudie.
Vi antar att BB-12 är säkert hos friska vuxna i åldrarna 18 och uppåt.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
40
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
District of Columbia
-
Washington, District of Columbia, Förenta staterna, 20007
- Georgetown University Medical Center
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inklusionskriterier:
- Förmåga att tala och skriva engelska eller spanska
- Kylskåp för korrekt förvaring av dryck
- Telefonåtkomst
- Anmälan måste ske inom 24 timmar efter start av antibiotika
- Behandling med en antibiotikakur av penicillinklass i 10 dagar för en övre luftvägsinfektion;
Följande är en lista över inklusive antibiotika:
- Amoxicillin
- Augmentin (amoxicillin/klavulanat)
- Ancef (cefazolin)
- Cefadroxil
- Cephalexin
- Cephradine
- Duricef (cefadroxil)
- Keflex (cefalexin)
- Kefzol (cefazolin)
- Velosef (cephradine)
- Ceclor (cefaclor)
- Cefotan
- Cefoxitin
- Ceftin (cefuroxim)
- Cefzil (cefprozil)
- Lorabid (loracarbef)
- Mefoxin (Cefoxitin)
- Zinacef (cefuroxim)
- Omnicef (cefdinir)
- Suprax (cefixime)
- Dikloxacillin
Pen-Vee K (penicillin)
- Antibiotika ordineras minst två gånger om dagen
- Polispatienter
Exklusions kriterier:
- Kroniska tillstånd, såsom diabetes eller astma, som kräver daglig medicinering
- Allergi mot jordgubbar
- Aktiv diarré
- Allergi mot penicillinklass antibiotika
- Alla andra läkemedel som används förutom receptbelagda antibiotika och febernedsättande läkemedel
Allergi mot någon av följande mediciner
- Tetracyklin
- Erytromycin
- Trimetoprim
- Ciprofloxacin
- Laktosintolerant.
- Under den fysiska grundundersökningen kommer något av följande att vara skäl för uteslutning; systoliskt blodtryck >140, systoliskt blodtryck <90, diastoliskt >90, syremättnad <98 %, puls >100, puls <55 och andningsfrekvens >17. Dessa inkluderar alla vitala tecken som faller utanför det "normala" intervallet, inklusive klass 1 till klass 4.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 1. Aktiv
Bifidobacterium animalis subsp. lactis (B. lactis) stam BB-12 (BB-12) Probiotisk, BB-12, kompletterad yoghurt, 4 ounces oralt i 10 dagar |
Bifidobacterium animalis subsp.
lactis (B.
lactis) stam BB-12 (BB-12) probiotisk kompletterad yoghurt, 4 ounces oralt i 10 dagar
Andra namn:
|
|
Placebo-jämförare: 2. Placebo
Yoghurt med jordgubbssmak
|
Yoghurt med jordgubbssmak
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Det primära resultatet är att bedöma säkerheten hos BB-12-yoghurt när den konsumeras av allmänt friska vuxna som konsumerar antibiotika.
Tidsram: 1 år
|
1 år
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Förutom säkerhetsdagboken kommer deltagarna att föra en daglig dagbok för att spåra antalet tarmrörelser, om dryck har konsumerats, om sjukdom resulterat i förändring i aktivitet, använda receptfria läkemedel och andra sjukdomssymtom.
Tidsram: 1 år
|
1 år
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
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- Cremonini F, Di Caro S, Nista EC, Bartolozzi F, Capelli G, Gasbarrini G, Gasbarrini A. Meta-analysis: the effect of probiotic administration on antibiotic-associated diarrhoea. Aliment Pharmacol Ther. 2002 Aug;16(8):1461-7. doi: 10.1046/j.1365-2036.2002.01318.x.
- Winnick S, Lucas DO, Hartman AL, Toll D. How do you improve compliance? Pediatrics. 2005 Jun;115(6):e718-24. doi: 10.1542/peds.2004-1133.
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- Nevins TE.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2009
Primärt slutförande (Faktisk)
1 juli 2011
Avslutad studie (Faktisk)
1 juli 2011
Studieregistreringsdatum
Först inskickad
18 februari 2009
Först inskickad som uppfyllde QC-kriterierna
19 februari 2009
Första postat (Uppskatta)
20 februari 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
20 maj 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 maj 2013
Senast verifierad
1 maj 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- R21AT003600-01A1
- IND # 13691 (Annan identifierare: FDA)
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