PROBIOTIC RECOLONISATION THERAPY
The present invention relates to pharmaceutical compositions suitable for the treatment of chronic diseases associated with the presence of abnormal or an abnormal distribution of microflora in the gastrointestinal tract of a mammalian host, which compositions comprise viable non-pathogenic or attenuated pathogenic Clostridia . The compositions further comprise one or more additional viable non-pathogenic or attenuated pathogenic microorganisms selected from the group consisting of Bacteroides , Eubacteria, Fusobacteria, Propionibacteria, Lactobacilli, anaerobic cocci, Ruminococcus, E. coli, Gemmiger, Desulfomonas, Peptostreptococcus , and fungi. The present invention also provides pharmaceutical compositions suitable for the treatment of the same chronic diseases comprising viable non-pathogenic or attenuated pathogenic Escherichia coli , at least one strain of viable non-pathogenic or attenuated pathogenic Bacteroides and at least one strain of viable non-pathogenic or attenuated pathogenic microorganism.
1 .- 182 . (canceled)
183 . A method for treating autism in a subject in need thereof, the method comprising administering to the subject an amount of a pharmaceutical composition effective for treating the autism,
wherein the pharmaceutical composition is selected from the group consisting of:
a. a disease screened fresh homologous feces;
b. a freeze-dried, or a freeze-dried and reconstituted feces;
c. a reconstituted feces, reconstituted using cultured viable non-pathogenic or attenuated microorganisms;
d. a synthetic fecal composition of predetermined flora;
e. a synthetic or reconstituted fecal composition comprising a preparation of viable flora in proportional content that resembles a normal healthy human fecal flora, which does not include antibiotic resistant populations;
f. a composition comprising viable, non-pathogenic colonic bacterial cells selected from the group consisting of a Clostridia , a Collinsella , a Bacteroides , a Fusobacteria , a Propionibacteria , a Lactobacilli , an anaerobic cocci, a Ruminococcus , an E. coli , a Gemmiger , a Desulfomonas , a Peptostreptococcus , a Bifidobacteria and any combination thereof;
g. a composition comprising viable, non-pathogenic colonic bacterial components of fecal flora, wherein said bacterial components comprise Clostridium bifermentans, Clostridium innocuum, Clostridium butyricum, Escherichia coli, Bacteroides and Peptostreptococcus productus;
h. a composition comprising viable, non-pathogenic colonic bacterial components of fecal flora, wherein said bacterial components comprise a Bacteroides , an Escherichia coli , and a non-pathogenic Clostridia,
i. a composition comprising a plurality of viable non-pathogenic Clostridia spores and a plurality of viable non-pathogenic Collinsella cells,
j. a composition comprising a plurality of viable non-pathogenic Clostridia,
k. a composition comprising a plurality of viable non-pathogenic Clostridia and a plurality of viable non-pathogenic Collinsella,
l. a composition comprising viable non-pathogenic Clostridia spores, a viable non-pathogenic Bacteroides , and a viable non-pathogenic Escherichia coli.
184 . The method of claim 083 , wherein said viable non-pathogenic Clostridia are from a species selected from the group consisting of Clostridium absonum, Clostridium argentinense, Clostridium baratii, Clostridium bifermentans, Clostridium botulinum, Clostridium butyricum, Clostridium cadaveris, Clostridium camis, Clostridium celatum, Clostridium chauvoei, Clostridium clostridioforme, Clostridium cochlearium, Clostridium difficile, Clostridium fallax, Clostridium felsineum, Clostridium ghonii, Clostridium glycolicum, Clostridium haemolyticum, Clostridium hastiforme, Clostridium histolyticum, Clostridium indolis, Clostridium innocuum, Clostridium irregulare, Clostridium limosum, Clostridium malenominatum, Clostridium novyi, Clostridium oroticum, Clostridium paraputrificum, Clostridium perfringens, Clostridium piliforme, Clostridium putrefaciens, Clostridium putrificum, Clostridium ramosum, Clostridium sardiniense, Clostridium sartagoforme, Clostridium scindens, Clostridium septicum, Clostridium sordellii, Clostridium sphenoides, Clostridium spiroforme, Clostridium sporogenes, Clostridium subterminale, Clostridium symbiosum, Clostridium tertium, Clostridium tetani, Clostridium welchii , and Clostridium villosum.
185 . The method of claim 183 , wherein said viable non-pathogenic Clostridia are from a species selected from the group consisting of Clostridium bifermentans, Clostridium innocuum , and Clostridium butyricum.
186 . The method of claim 183 , wherein said viable non-pathogenic Collinsella comprise Collinsella aerofaciens.
187 . The method of claim 183 , wherein said pharmaceutical composition further comprises an acid suppressant, an antacid, an H2 antagonist, a proton pump inhibitor or a combination thereof.
188 . The method of claim 183 , wherein said pharmaceutical composition is formulated as an enteric coated capsule, an enteric coated microcapsule, a powder suitable for reconstitution, a naso-duodenal infusion, or for delivery in the form of an enema or a colonoscopic infusion.
189 . The method of claim 1830 , wherein said pharmaceutical composition is added to a food, a food additive, a dairy-based product, a soy-based product or a derivative thereof, a jelly, or a yogurt.
190 . The method of claim 183 , wherein no existing enteric microflora is removed from said subject prior to administration of said pharmaceutical composition.
191 . The method of claim 183 , wherein some existing enteric microflora is removed from said subject prior to administration of said pharmaceutical composition.
192 . The method of claim 183 , wherein the subject is pretreated with an antibiotic prior to administration of said pharmaceutical composition.
193 . The method of claim 183 , wherein the subject is pretreated with an acid suppressant prior to administration of the pharmaceutical composition.
194 . The method of claim 183 , wherein the pharmaceutical composition is administered three times daily (tid).
195 . The method of claim 183 , wherein the subject is pretreated with an orthostatic lavage prior to administration of the pharmaceutical composition.
196 . The method of claim 183 , wherein the subject is pretreated with an orthostatic lavage and antibiotic treatment prior to administration of the pharmaceutical composition.
197 . The method of claim 183 , wherein the subject is pretreated with an orthostatic lavage and antibiotic treatment prior to administration of the pharmaceutical composition, and the pharmaceutical composition comprises a plurality of bacteria comprising a Bacteroides , an Escherichia coli , and a non-pathogenic Clostridia,
and the pharmaceutical composition at a concentration of 10 9 through to 10 10 .
198 . The method of claim 183 , wherein the subject is pretreated with an antibiotic prior to administration of the pharmaceutical composition,
and after the pre-treatment with the antibiotic the subject is pretreated with an orthostatic lavage prior to administration of the pharmaceutical composition.
199 . The method of claim 183 , wherein the pharmaceutical composition comprises between about 10 3 and about 10 13 viable bacterial cells.
200 . The method of claim 199 , wherein the pharmaceutical composition comprises between about 10 5 and about 10 11 viable bacterial cells.
201 . The method claim 200 , wherein the pharmaceutical composition comprises between about 10 9 and about 10 11 viable bacterial cells.
202 . The method of claim 201 , wherein the pharmaceutical composition comprises about 10 10 viable bacterial cells.
203 . The method of claim 183 , wherein the autism is associated with Irritable Bowel Syndrome or gastrointestinal symptoms.