WO1996011014A1 - Treatment of bowel-dependent neurological disorders - Google Patents
Treatment of bowel-dependent neurological disorders Download PDFInfo
- Publication number
- WO1996011014A1 WO1996011014A1 PCT/AU1995/000664 AU9500664W WO9611014A1 WO 1996011014 A1 WO1996011014 A1 WO 1996011014A1 AU 9500664 W AU9500664 W AU 9500664W WO 9611014 A1 WO9611014 A1 WO 9611014A1
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- WO
- WIPO (PCT)
- Prior art keywords
- eubacterium
- bacteroides
- ruminococcus
- microorganisms
- fragilis
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/742—Spore-forming bacteria, e.g. Bacillus coagulans, Bacillus subtilis, clostridium or Lactobacillus sporogenes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K35/745—Bifidobacteria
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Definitions
- This invention relates to a method for the treatment and/or prophylaxis of a sleep disorder or of inducing sleep or for the treatment and/or prophylaxis of SIDS or neuropsychiatric disorders in a mammal.
- the present invention also relates to pharmaceutical compositions used in the methods and processes for their manufacture.
- Sleep deprivation may be the result of a change in work patterns such as occurs with shift-workers or people working long hours, regular travel to different time zones or may also be due to a secondary effect of drug administration for other purposes. Sleep deprivation may also fall within the category of conventional amnesia which can occur for a wide range of medical and/or psychological reasons. Sleep deprivation is not only distressing and upsetting for the patient concerned, but it is also recognised that sleep deprivation has a suppressing effect upon the immune system.
- a sleep-inducing substance(s) in the brain and in the body fluids of animals deprived of sleep Increases in sleep behaviour can be observed by administering extracts from sleep-deprived animals into normal waking recipients 1 2 .
- a low molecular weight peptide with potent sleep-inducing properties has been isolated from the brain, cerebrospinal fluid and urine of various mammalian species including man 1 - 2 3 .
- the peptide Factor S (FS) has specifically been shown to increase the Slow Wave Sleep (SWS) component of sleep in rates and rabbits without affecting the Rapid
- FS has been shown to be a muramyl peptid possibly of the sequence N-acetyl-glucosaminyl-N-acetyl-muramyl-L-alanyl-D-glutamyl-mesodiaminopimelyl-D- alanine 5 .
- Muramyl peptides occur naturally as monomeric components of the bacterial cell wall 6 and to our present knowledge are unable to be synthesised by mammalian cells 7 .
- Recently Kreuger et ⁇ / 8 speculated on the possible relationship between the ontogeny of SWS and the colonisation of the gastrointestinal tract with bacteria.
- Brown et ⁇ 9 proposed that the ontogeny of SWS parallels the colonisation of the gastrointestinal tract in animals by the so called autochthonous flora, and that this flora can be acquired in the lower animals such as rats, by coprophagy supplying a source of FS-like products while colonising the gastrointestinal tract with adult bowel flora.
- the gastrointestinal tract of mammals is sterile before birth. During delivery and on exposure to the environment there occurs a rapid infestation or colonisation of the intestinal tract with microbes 10 . In the rat, for example, within the first few hours of life there appears colonisation by Lactobacillus and E. coli which remain dominant until the establishment of the strict anaerobes by the third week of life.
- the strict anaerobes comprise as much as 99% of the gut flora 10 ".
- Bacteroides species are amongst the most predominant of the strict anaerobes 10 11 and, along - th several less common bacterial species, make up what is collectively known as ⁇ V ⁇ tochthonous flora, native to the gastrointestinal tract of the host.
- mice dietary changes in mice have produced dramatic alterations in gut flora, supporting such observations made above 15 .
- Clostridium botulinum toxin is a classical example of a microorganism-derived substance which can alter the circulation and cause sv temic toxicity resulting in neuromuscular effects which in infants translate clinically as chronic fatigue" to the point of apnoea and death in extreme cases.
- the bowels in these children are often markedly constipated. More recently greater recognition of bowel-derived toxins has appeared and there is compelling evidence that certain strains of Campylobacter jejuni produce substances which can influence areas of spinal cord and initiate the Guillain-Barre syndrome 21 .
- SIDS small infant death syndrome
- a significantly higher proportion of toxigenic microorganisms and their toxins were found in foetal samples of SIDS babies than in samples from the comparative group of living age-matched babies 22 .
- the effects of the toxins were studied in a rabbit model showing that these can profoundly affect the heart rate, blood pressure, respiration and thoracic expansion, and at higher concentrations resulted in prolonged apnoea causing sudden death without distress 23 .
- Australian Patent No. 640349 demonstrates that bowel flora therapy can be used to treat Irritable Bowel Syndrome. That Australian patent describes the use of cultured microorganisms replacement to treat Irritable Bowel Syndrome. It has also been proposed in European Patent No. 245529 and United States Patent No. 4,698,330 that isolated natural or synthetic muramyl peptides are active in mammals as slow-wave sleep inducers. However, United States Patent No. 4,698,330 acknowledges the problem of pyrogenicity which is associated with administration of muramyl peptides for sleep induction, and this document in fact advocates the use of an anti-pyretic agent in conjunction with the muramyl peptide administration. Clearly, the use of anti-pyretic agents is not desirable as the administration of such agents may result in other undesirable side effects.
- the present inventors have surprisingly found that patients being treated for Irritable Bowel Syndrome (and who had a concomitant diagnosis of Chro. Fatigue Syndrome or insomnia) by bowel flora therapy showed a dramatic disappearance in their sleep disorder.
- a method for the treatment and/or prophylaxis of a sleep disorder or for inducing sleep or for the treatment and/or prophylaxis of a neuropsychiatric disorder or for the treatment and/or prophylaxis of SIDS or Chronic Fatigue Syndrome in a mammal which comprises administering to said mammal an effective amount of whole live or dead enteric microorganisms or cell wall containing fragments of said enteric microorganisms.
- a pharmaceutical composition which comprises whole dead microorganisms or cell wall containing fragments of said microorganisms in association with one or more pharmaceutically acceptable carriers and/or diluents and optionally in association with other pharmaceutically active agents.
- a method of manufacture of a pharmaceutical composition comprising obtaining a sample of enteric microorganisms and disrupting said microorganisms and then extracting from disrupted microorganisms cell wall containing fragments thereof which are then combined with one or more pharmaceutically acceptable carriers, excipients and/or adjuvents.
- microorganisms comprehended by the present invention are selected from Bacteroides, Bifidobacterium, Eubacteria, Fusobacteria, Propionibacteria, Lactobacilli, anaerobic cocci, Ruminococcus, Esche ⁇ chia, Gemmiger, Clostridium or Desulfomonas genera or species.
- microorganisms are selected from Bacteroides fragilis ss. vulgatis, Eubacterium aerofaciens, Bacteroides fragilis ss. thetaiotaomicron, Peptostreptococcus productus II, Bacteroides fragilis ss.
- distasonis Fusobacterium prausnitzii, Coprococcus eutactus, Eubacterium aerofaciens III, Peptostreptococcus productus I, Ruminococcus bromii, Bifidobacterium adolescentis, Gemmiger formicilis, Bifidobacterium longum, Eubacterium siraeum, Ruminococcus torques, Eubacterium rectale III-H, Eubacterium rectale IV, Eubacterium eligens, Bacteroides eggerthii, Clostridium leptum, Bacteroides fragilis ss.
- ruminocoli Bacteroides splanchnicus, Desulfi nionas pigra, Bacteroides L-4, -W-l; Fusobacterium H, Lactobacillus G G, or Succinivibrio A.
- the microorganisms used are a mixture of "Bacteroides and E. coli".
- the microorganisms may be prepared as a liquid culture or they may be freeze-dried.
- Microorganisms used in the invention may be live or dead and in fact it is possible to also carry out the invention by utilising cell wall containing fragments of the dead microorganisms. If the microorganisms are dead they are preferably encapsulated prior to use.
- the mammal Prior to administering the microorganisms into a mammal, the mammal 's existing enteric microflora may be substantially removed. This is however merely an optional aspect of the invention and is most preferable in the situation where live microorganisms are being administered to the mammal.
- the removal of existing enteric microflora is effected by lavage of the gastro-intestinal tract. This can be effected by methods known to those skilled in the art such as ingestion of lavage solutions such as orthostatic salt and polyethyleneglycol solution, enemas or small bowel intubation and lavage. A short course of antibiotics may be required to rid tissue-invasive pathogens originating in the bowel lumen.
- the live or dead microorganisms or cell wall contain fragments thereof are introduced into the gastrointestinal system by enemas or coloi. --. ⁇ ope, via intubation of the small bowel using for example a large bore catheter equipped with distal balloon to effect rapid passage down the jejunum, or by infusion into the small bowel, or via the oral route with a capsule or tablet which may or may not be enterically coated.
- the product is administered orally as a capsule or tablet which may be enterically coated or mixed with food or beverage.
- the product is in a dried powder form which can be mixed with a drink for administration to a patient.
- the methods of the present invention are applicable to mammals in general, and in particular to humans.
- sleep disorders treated or cured by the methods of the present invention are narcolepsy, hypersomnia, insomnia or sleep apnoea. Sleep disorders comprehended by the present invention may also be caused by immune system depression within the mammal.
- neuropsychiatric disorders which may be treated or prevented by the methods according to the present invention are depression, psychosis, neurosis, catatonia, hyperactivity syndrome, manic depressive illness or anorexia nervosa. It is also envisaged that Chronic Fatigue Syndrome and children's Cl. Botulinum poisoning can be treated according to the methods of the present invention.
- the present invention is also effective as a treatment and/or preventative measure in relation to sudden infant death syndrome (SIDS).
- the methods of the present invention may further comprise the administration of an adjuvant or other pharmaceutically acceptable carriers or excipients or in fact other pharmaceutically active agents in conjunction with the microorganisms or cell wall containing fragments thereof.
- an adjuvant examples include a gastric suppressant such as a milk product or an antacid which can be used to dampen bacterial inactivation in the stomach, an H 2 -receptor antagonist or omeprazole which can be used to suppress stomach acid secretion or a proton pump inhibitor which will have a similar stomach acid secretion suppressive effect.
- a gastric suppressant such as a milk product or an antacid which can be used to dampen bacterial inactivation in the stomach
- an H 2 -receptor antagonist or omeprazole which can be used to suppress stomach acid secretion or a proton pump inhibitor which will have a similar stomach acid secretion suppressive effect.
- the bowel flora replacement therapy which can be utilised in the present invention is comprehended within Australian Patent No. 640349.
- treatment in some instances will also be possible without prior bowel flora removal, simply by overseeding with the new introduced microorganisms, by longer term ingestion of the new flora utilising enteric-coated capsules.
- gastric acid suppression by the use of milk products antacids, H 2 -receptor antagonists or proton pump inhibitors may be utilised to enhance mircoorganisms survival rates during passage of microorganism through the stomach.
- flora manipulation can be employed either as a therapy in suspected pre-SIDS or near-SIDS cases as a treatment of children who on stool screen were found to have detectable toxins of microorganisms associated with SIDS (eg. Cl. Perfringens, Cl. difficile, S. Aureaus, Cl. botulinum) or as a broad-spectrum prophylactic therapy in most newborn children to prevent colonisation by toxin-producting microorganisms.
- the therapeutic benefits associated with the present invention are due to liberation of muramyl peptides from the microorganisms administered according to the invention. It appears however, that the muramyl peptides can only be liberated by the action of the enzymes N-acetylmuramoyl- L-alanine-amidase from bacterial cell walls of bacterial cell fragments. In turn therefore, it appears most likely that the therapeutic benefit associated with the present invention is achieved after microorganisms which may have been administered alive or dead but whole have been broken down into cell wall containing fragments.
- the method of increasing muramyl peptide availability within the body and thereby increasing the factor S levels in the brain to induce sleep and improved immune system activity can be achieved by administering either whole live or dead microorganisms or cell wall containing fragments of the microorganisms which contain muramyl peptides within their cell walls.
- the methods according to the invention overcome the pyrogenicity problems associated with administering isolated natural maramyl peptides or synthetic muramyl peptides.
- the cell wall containing fragments of the microorganisms of the invention can be obtained from any of the microorganism species referred to herein and especially species from the Genera Escherichia, Acidophilus and Bifidobacterium by lysing or disrupting the cells in any of a number of ways.
- the cells may be subjected to puliverisation by passage through a blender or milling with glass beads. They may be centrifuged, sonicated, homogenised, heated, exposed to osmotic shock or treated with enzymes or chemicals which result in cell lysis or disruptions. In general it is suggested that during the disruption process the cells be maintained in solution although it is also possible to effect disruption when the cells are not in solution.
- Lysozymes are bacteriacidal enzymes which cleave the 0-1,4 bond of the bacterial cell wall and thereby liberate the cell contents.
- lysozyme treatment is carried out in a sucrose solution so that the products are cleaved bacterial cell walls and spheroplasts.
- compositions comprising the microorganisms or cell wall containing fragments thereof can follow the standard procedures generally known in the art, and reference can conveniently be made to Wellington's Pharmaceutical Sciences, 17th Edition, Mack Publishing Co. , Easton, Pennyslvania, United States of America.
- the dosage regime will depend upon many factors such as for example the age, sex, weight and the particular species of mammal concerned. Also of importance in considering the required administration level will be the nature of the disorder which is intended to be treated or prevented according to the method of the present invention, also taking into account any other therapeutic treatments which the patient concerned may be concurrently undergoing. For example, from about 0.5 micrograms to about 5 grams per kilogram body weight of microorganism or cell wall containing fragments thereof may be administered to the patient per day. Dosage regime may be adjusted to provide the optimum therapeutic response. For example, several divided doses may be administered daily or the dose may be proportionally reduced as indicated by the exigencies of the therapeutic situation.
- the active compound may be administered in a convenient manner such as by the oral route or by infusion or intubation into the intestines.
- the microorganism or cell wall containing fragments thereof may be required to be coated in a material to protect them from the action of enzymes, acids and other natural conditions which may inactivate them.
- the peptides may be dministered in an adjuvant or co-administered with enzyme inhibitors or even within lysozymes or standard pharmaceutical capsules.
- Adjuvants according to the invention have been referred to above and enzyme inhibitors include for example pancreatic trypsin inhibitor while lysozyme may include water-in-oil-in-water CGF emulsions as well as conventional lysozyme.
- enzyme inhibitors include for example pancreatic trypsin inhibitor while lysozyme may include water-in-oil-in-water CGF emulsions as well as conventional lysozyme.
- the microorganism cell wall containing fragments thereof may be orally administered for example with an inert diluent or with an assimible edible carrier, or may be enclosed in hard or soft shell gelatin capsule, may be compressed into tablets or may be incorporated directly with the food of the diet.
- the active compound may be incorporated with excipients and used in the form of ingestibl * tablets, buccal tab e . , capsules, elixirs suspensions, syrups, wafers and the like, it is preferred
- Foo MC Lee A. , Immunological response of mice to members of the autochthonous intestinal flora. Infection and Immunity 1972; 6:525-532.
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU36014/95A AU706968B2 (en) | 1994-10-07 | 1995-10-06 | Treatment of bowel-dependent neurological disorders |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AUPM8648A AUPM864894A0 (en) | 1994-10-07 | 1994-10-07 | Treatment of bowel-dependent neurological disorders |
AUPM8648 | 1994-10-07 |
Publications (1)
Publication Number | Publication Date |
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WO1996011014A1 true WO1996011014A1 (en) | 1996-04-18 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/AU1995/000664 WO1996011014A1 (en) | 1994-10-07 | 1995-10-06 | Treatment of bowel-dependent neurological disorders |
Country Status (3)
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AU (1) | AUPM864894A0 (en) |
NZ (1) | NZ293542A (en) |
WO (1) | WO1996011014A1 (en) |
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