US2010226899A1PendingUtilityA1

Categorization of Microbial Communities

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Assignee: IDAHO RES FOUNDATIONPriority: Jan 14, 2005Filed: Oct 23, 2009Published: Sep 9, 2010
Est. expiryJan 14, 2025(expired)· nominal 20-yr term from priority
Inventors:Thomas C. OsbornCatherine Cornick DavisBruce JohnsLarry J. ForneyJames J. FosterCeleste BrownPaul JoyceZaid AbdoAudra JohnsonXia Zhou
Y02A90/10A61K 35/747A61K 35/741C12N 15/111C12N 2320/32Y02A50/30C12Q 1/6837C12N 2310/11C12Q 1/689C12N 2310/14C12N 2330/50
58
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Claims

Abstract

The present disclosure provides embodiments of a method for characterizing microbial populations. Exemplified by methods for characterizing microbiota in vaginal samples, the methods provided herein are widely applicable to the characterization of microbial communities. Also provided are probiotic regimens and methods for selecting appropriate probiotic regimens based on the normal vaginal microbiota of a subject. Reagents and kits for detecting normal vaginal microbiota and diagnosing pathogenic microorganisms in the vagina are also provided.

Claims

exact text as granted — not AI-modified
1 .- 3 . (canceled) 
     
     
         4 . A method of designing a probiotic regimen for maintaining and establishing a healthy vaginal microbiota comprising:
 determining the presence and prevalence of microorganisms in a vaginal sample; and   selecting a probiotic regimen that corresponds to one or more predominant microorganisms present in the sample, wherein the one or more predominant microorganisms is selected from the group consisting of  Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri, Atopobium vaginae, Megasphaera  sp., one or more species of the order Clostridiales, combinations thereof, and mixtures thereof.   
     
     
         5 . The method of  claim 4 , wherein the one or more predominant microorganisms is a  Lactobacillus  species selected from the groups consisting of  Lactobacillus crispatus, Lactobacillus iners, Lactobacillus jensenii, Lactobacillus gasseri , combinations thereof, and mixtures thereof. 
     
     
         6 . The method of  claim 4 , wherein the probiotic regimen comprises administering to a female a probiotic formulation comprising  Lactobacillus iners.    
     
     
         7 . The method of  claim 4 , wherein the probiotic regimen comprises administering to a female a probiotic formulation comprising  Lactobacillus crispatus.    
     
     
         8 . The method of  claim 4 , wherein the probiotic regimen comprises administering to a female a probiotic formulation comprising  Lactobacillus crispatus  and  Lactobacillus jensenii.    
     
     
         9 . The method of  claim 4 , wherein the probiotic regimen comprises administering to a female a probiotic formulation comprising  Lactobacillus iners, Lactobacillus crispatus  and  Lactobacillus gasseri.    
     
     
         10 . The method of  claim 4 , wherein the probiotic regimen comprises administering to a female a probiotic formulation comprising  Lactobacillus crispatus  and  Lactobacillus gasseri.    
     
     
         11 . The method of  claim 4 , wherein the probiotic regimen comprises administering to a female a probiotic formulation comprising  Lactobacillus crispatus, Lactobacillus iners  and  Lactobacillus jensenii.    
     
     
         12 . The method of  claim 4 , wherein the probiotic regimen is administered to a subject prophylactically. 
     
     
         13 . The method of  claim 4 , wherein the probiotic regimen is administered to a subject therapeutically. 
     
     
         14 . The method of  claim 4 , wherein the probiotic regimen further comprises one or more pharmaceutical or nutritional compositions that promote growth of the selected microorganism(s). 
     
     
         15 . The method of  claim 4 , wherein the one or more microorganisms are administered together, substantially simultaneously, or sequentially. 
     
     
         16 . The method of  claim 4 , wherein the one or more microorganisms are administered in the form of a liquid, dispersion, suppository, tablet, pill, capsule, freeze-dried capsule. 
     
     
         17 . The method of  claim 4 , wherein the one or more microorganisms are administered with a biologically compatible device for insertion into the urogenital tract, wherein the biologically compatible device is coated or impregnated with an effective amount of the selected microorganisms. 
     
     
         18 . The method of  claim 4 , wherein the one or more microorganisms are administered at a dose of at least 10 9  viable cells. 
     
     
         19 . A method for establishing or maintaining a normal bacterial community, the method comprising: identifying one or more predominant species of microbiota in a biological sample, wherein the species are from a category of normal vaginal microbiota, thereby producing a microbiota profile; and providing a composition comprising one or more species of microorganism selected from the normal microbiota present in the microbiota profile. 
     
     
         20 . The method of  claim 19 , wherein the category of normal vaginal microbiota is a category of normal vaginal microbiota of a racially or ethnically defined population of women. 
     
     
         21 . The method of  claim 19 , comprising providing a pharmaceutically acceptable formulation comprising one or more species of microorganism from a category of normal vaginal microbiota selected from the group consisting of: a)  Lactobacillus iners ; b)  Lactobacillus crispatus ; c)  Lactobacillus crispatus  and  Lactobacillus jensenii ; d)  Lactobacillus iners, Lactobacillus crispatus  and  Lactobacillus gasseri ; e)  Atopobium vaginae  and one or more species of the order Clostridiales; f)  Lactobacillus crispatus  and  Lactobacillus gasseri ; g)  Lactobacillus crispatus, Lactobacillus iners  and  Lactobacillus jensenii . h)  Streptococcus  sp.,  Veillonella  sp. and  Gemella palaticanis ; i)  Streptococcus  sp.; and j)  Lactobacillus gasseri.    
     
     
         22 . The method of  claim 19 , comprising providing a pharmaceutically acceptable formulation comprising one or more species of microorganism from a category of normal vaginal microbiota selected from the group consisting of: a)  Lactobacillus iners ; b)  Lactobacillus crispatus ; c)  Atopobium vaginae  and one or more species of the order Clostridiales; d)  Lactobacillus gasseri ; e)  Megasphaera  sp. and one or more species of the order Clostridiales; f)  Lactobacillus gasseri, Gardinerella vaginalis  and  Streptococcus  sp.; g)  Escherichia coli  and  Shigella  sp.; h)  Lactobacillus jensenii  and  Streptococcus  sp.; and, i)  Gemella palaticanis  and  Mycoplasma  sp. 
     
     
         23 . A method for selecting a probiotic regimen for establishing or maintaining a normal category of vaginal microbiota in a subject, the method comprising: identifying one or more predominant species of microbiota in a vaginal sample from a subject, wherein the species are from a category of normal vaginal microbiota, thereby producing a vaginal microbiota profile; and selecting a probiotic regimen comprising one or more species of normal vaginal microbiota selected from the vaginal microbiota profile. 
     
     
         24 . The method of  claim 23 , comprising selecting a safe and effective probiotic regimen. 
     
     
         25 . A probiotic regimen for establishing or maintaining a normal category of vaginal microbiota, the probiotic regimen comprising at least one species of microorganisms selected from a normal vaginal microbiota other than a species of  Lactobacillus.    
     
     
         26 . The probiotic regimen of  claim 25 , wherein the probiotic regimen comprises  Atopobium vaginae.    
     
     
         27 . A probiotic composition comprising administering to a female a probiotic formulation comprising  Lactobacillus crispatus  and  Lactoba cillus jensenii.    
     
     
         28 . A probiotic composition comprising  Lactobacillus iners, Lactobacillus crispatus  and  Lactobacillus gasseri.    
     
     
         29 . A probiotic composition comprising  Lactobacillus crispatus  and  Lactobacillus gasseri.    
     
     
         30 . A probiotic composition comprising  Lactobacillus crispatus, Lactobacillus iners  and  Lactobacillus jensenii.

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