WO2010071421A1 - Probiotiques destinés à traiter et/ou à prévenir l'hypertension pulmonaire - Google Patents

Probiotiques destinés à traiter et/ou à prévenir l'hypertension pulmonaire Download PDF

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Publication number
WO2010071421A1
WO2010071421A1 PCT/NL2009/050762 NL2009050762W WO2010071421A1 WO 2010071421 A1 WO2010071421 A1 WO 2010071421A1 NL 2009050762 W NL2009050762 W NL 2009050762W WO 2010071421 A1 WO2010071421 A1 WO 2010071421A1
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Prior art keywords
composition
pulmonary
composition according
bacteria
treatment
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English (en)
Inventor
Johan Garssen
Jeroen Van Bergenhenegouwen
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Nutricia NV
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Nutricia NV
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    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/702—Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
    • 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
    • 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

Definitions

  • Probiotics for the treatment and/or prevention of pulmonary hypertension are provided.
  • This invention pertains to a method for treatment or prevention of pulmonary hypertension in a patient.
  • the invention further relates to supplements especially beneficial in stopping the progression of or reversing the symptoms of pulmonary hypertension.
  • the present invention provides a novel use for probiotic bacteria, either live or dead or non-viable, as well as food supplements, nutritive compositions and/or pharmaceutical compositions comprising these, for the treatment or prophylaxis of pulmonary lung diseases in a subject.
  • Pulmonary hypertension is a condition that is characterized by thickened arterial walls of the vessels in the lung.
  • the condition may be congenital PH, primary PH where the initial lesion is in the lungs or acquired PH from failure of other members of the cardiac-pulmonary axis.
  • Congenital PH is generally due to a left-right shunt associated with ventricular or atrial septal defects or patent ductus arteriosus.
  • Primary PH may be caused by emphysema, chronic asthma, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, and pulmonary embolism with parenchymal infarct, reactive pulmonary blood vessels or tissues.
  • COPD chronic obstructive pulmonary disease
  • PH Some of the triggers for acquired PH are exposures to toxins, infections, smoking, and residence at high altitudes. Whatever the nature, congenital, primary or acquired, PH eventually leads to right ventricular hypertrophy with or without heart failure. Patients are able to compensate with conventional medical therapies and can stabilize for an indefinite time. Other patients afflicted with this condition die due to progressive heart decompensation or may require a heart/lung transplant or long term oxygen therapy.
  • Cor pulmonale is defined as right ventricular hypertrophy and dilatation or both, secondary to PH caused by respiratory disorders
  • etiology of acquired PH may not yet be known, one common factor leading to the condition may be that the pulmonary blood vessels and lung tissue are very sensitive to certain factors that trigger the development of the disease. Among these suspected factors are a preexisting condition of Raynaud's syndrome, appetite suppressants, cocaine, and congestive heart failure. Certain disease states such as emphysema, reactive airway disease, chronic obstructive pulmonary disease, H IV infection, scleroderma and systemic lupus erythematosus are often accompanied by PH.
  • Treatment commonly is merely symptomatic. Methods of lowering of the vasculature's blood pressure in those patients with hypertension may give some relief.
  • US 6,218,366 discloses a therapeutic method comprising administering ribose to a mammal in an effective amount to increase the tolerance of the mammal to hypoxia, wherein the hypoxia is due to cardiovascular disease, myocardial stunning, anaesthesia, surgical procedures, peripheral vascular disease, intermittent claudication, pulmonary dysfunction, physical exertion, pharmaceutical treatment, tachycardia or poisoning.
  • US 6,420,342 discloses a nutritional composition, comprising ribose and folate in amounts which are effective to support total nucleotide metabolism, and 0.1-8 g orotate per 5 g of ribose.
  • WO 2006/050585 Discloses a food product comprising at least one betaine and L-arginine in a combined amount effective to induce and/or to sustain a physiological increase in nitric oxide production in a mammal after ingesting said food product. This is claimed to be beneficial for the treatment of pulmonary hypertension by lowering the blood pressure.
  • WO 2005/058335 discloses the use of LMG P-22110 (L rhamnosus NRCC L572) for the treatmen or prophylaxis of COPD.
  • probiotic bacteria can prevent heart disease caused by pulmonary dysfunction.
  • probiotic bacteria are lactic acid producing bacteria, preferably selected from the group consisting of Lactobacillus and Bifidobacterium. Strains of probiotic bacteria of these species are highly effective in the prevention of heart disease caused by pulmonary dysfunction.
  • the composition comprising probiotica bacteria is used for the treatment and prevention of pulmonary hypertension.
  • RVH right ventricular hypertrophy
  • RVH is the earliest sign of right ventricular pressure overload (hypertension) in patients with COPD. This structural adaptation of the heart does not alter right ventricular and left ventricular systolic function, see Vonk-Noordegraaf et al., Chest 2005; 127:1898-1903.
  • the present invention thus concerns a method for the treatment or prevention of pulmonary heart disease, in particular pulmonary hypertension, said method comprising administering an effective amount of probiotc bacteria to a subject.
  • the present invention concerns the use of probiotic bacteria for the preparation of a composition for the treatment and/or prevention of pulmonary heart disease, in particular pulmonary hypertension.
  • the invention concerns a composition comprising probiotic bacteria for use in the treatment and/or prevention of pulmonary heart disease, in particular pulmonary hypertension.
  • probiotic bacteria refers to strains of live micro-organisms, preferably bacteria, which have a beneficial effect on the host when ingested (e.g. enterally or by inhalation) by a subject.
  • Normal pulmonary arterial pressure has a mean value of 12-16 mm Hg.
  • pulmonary hypertension PH is defined as a mean pulmonary artery pressure of >20 mm Hg and is placed in the heterogeneous group of PH associated with disorders of the respiratory system and/or hypoxaemia.
  • the term "out-of-proportion" pulmonary hypertension, in particular in patients with COPD, is defined by a mean pulmonary artery pressure >35-40 mm Hg and a relatively preserved lung function (with low to normal arterial carbon dioxide tension) that cannot explain prominent dyspnoea and fatigue.
  • the probiotic bacteria used are preferably lactic acid producing bacteria, preferably of the genus
  • Lactobacillus or Bifidobacterium The bacteria preferably are food-grade, i.e. they are preferably considered as not harmful, when ingested by a human or animal subject. It is understood that non-food grade bacteria, for example pathogenic bacteria, which have been modified so that they are no longer harmful when ingested by a subject, are included within the scope of the invention.
  • the Lactobacillus strains may be of the following species: L. rhamnosus, L. casei, L. paracasei, L. helveticus, L. delbrueckii, L. reuteri, L. brevis, L. crispatus, L. sakei, L. jensenii, L.
  • L. fructivorans L. kefiri, L. curvatus
  • L. paraplantarum L. kefirgranum
  • L. parakefir L. fermentum
  • L. plantarum L. acidophilus
  • L. johnsonii L gasseri, L xylosus, L salivarius etc.
  • Preferred species are L rhamnosus, L casei, L paracasei, L. reuteri, L. crispatus, .L fermentum L. plantarum L. acidophilus, L. johnsonii L. gasseri L salivarius, more preferred are L. plantarum, L. casei or L. rhamnosus. Most preferred is to use Lactobacillus strains belonging to the species L. casei.
  • the Bifidobacterium strains may be of the following species: B. longum, B. breve, B. animalis, B. infantis, B. bifidum, B. adolescentis, B. pseudolongum, B. catenulatum, B. pseudocatenulatum, B. angulatum etc.
  • Preferred species are B. breve and/or B. animalis (especially B. animalis subspecies lactis).
  • the species identity of micro-organisms can be determined biochemically or by sequencing (e.g. conserved regions) or by known methods such as pulse field gel electrophoresis.
  • strains of bacteria belong to the same species if they show at least 97 % nucleic acid sequence identity in the 16 S rRNA region (e.g. when optimally aligned by for example the programs GAP or BESTFIT using default parameters).
  • the probiotic bacteria used acoording to thepresent invention are selected from the group consisting of B. breve M-16V, L rhamnosus NRCC L572, DN 114 001 and DN 173 010.
  • L rhamnosus NRCC L572 has previously been deposited in accordance with the Budapest Treaty at the Belgian Co-ordination Collections of Microorganisms, BCCMTM, Gent, Belgium, under Accession No. LMG P-22110.
  • L casei DN-114 001 has previously been deposited in accordance with the Budapest Treaty at the Collection Nationale de Cultures de Microorganisms (CNCM, lnstitut Pasteur, Paris, France) under the number 1-1518. Bifidobacterium animalis. DN- 173 010 also previously has been deposited in accordance with the Budapest Treaty at the Collection Nationale de Cultures de Microorganisms (CNCM, lnstitut Pasteur, Paris, France) and is registered under the number CNCM 1-2494. B. breve M-16V is from Morinaga Milk Industry, Kanagawa, Japan.
  • the present composition comprises 10 2 to 10 13 colony forming units (cfu) of probiotic bacteria per gram (g) dry weight of the present composition, or 10 2 to 10 12 cfu, or 10 3 to 10 10 cfu, or from 10 4 to 5xlO 9 cfu.
  • the present composition comprises 10 2 to 10 13 colony forming units (cfu) per gram (g) dry weight of the present composition, or 10 2 to 10 12 cfu, or 10 3 to 10 10 cfu, or from 10 4 to 5xlO 9 cfu of one selected from the group consisting of B. breve M-16V, L rhamnosus NRCC L572, DN 114 001 and DN 173 010.
  • dead or non-viable bacterial cells of the probitic bacteria are used in the above compositions, instead of or in addition to live (or viable) bacteria, as for example described in WO 01/95741.
  • the amount of dead or non-viable cells used may, for example, be equivalent to that used for live bacteria. Suitable amounts can be easily determined by a skilled person. In such compositions, the amounts of cells are counted (e.g. using a flowcytometer) or measured in a different way as known to a skilled person, as measurement as 'colony forming units' is not feasible.
  • compositions comprising living cells this encompasses cells which are viable, such as for example lyophilised cells, which become active again after administration or reconstitution with liquid.
  • the present composition further comprises dietary fibres (prebiotics).
  • Dietary fibres as used in the present invention are typically resistant to digestion and absorption in the human small intestine with preferably a complete or partial fermentation in the large intestine.
  • the present composition comprises at least one dietary fibre selected from the group consisting of galactooligosaccharides, trans galactooligosaccharides, inulin, fructooligosaccharides (FOS) including long chain FOS (IcFOS) and short chain FOS (scFOS) and mixtures thereof, xylooligosaccharides, palatinoseoligosaccharide, soybean oligosaccharide, gentiooligosaccharide, pectin, pectin hydrolysate, pectate, alginate, chondroitine, hyaluronic acids, heparine, heparane, sialoglycans, fucoidan, fucooligosaccharides, carrageen
  • the dietary fibres are selected from galactooligosaccharides (GOS), trans- galactooligosaccharides (TOS), fructooligosaccharides (FOS) and pectin hydrolysate.
  • GOS galactooligosaccharides
  • TOS trans- galactooligosaccharides
  • FOS fructooligosaccharides
  • pectin hydrolysate pectin hydrolysate
  • the composition made using one or more strain(s) according to the invention may be any type of composition, which is suitable for a human subject suffering from pulmonary heart diseases, especially pulmonary hypertension.
  • the composition may be a food, a food supplement composition, nutritive (food) composition or pharmaceutical composition.
  • nutritive (food) composition or pharmaceutical composition.
  • the components and texture of the composition may vary.
  • a food or food/nutritive composition comprises besides the bacterial strain(s) of the invention also a suitable food base.
  • a food or food composition is herein understood to include solids (for example powders), semisolids and/or liquids (e.g. a drink or beverage) for human or animal consumption.
  • a food or food/nutritive composition may be a dairy product, such as a fermented dairy product, including but not limited to yoghurt, a yoghurt-based drink or buttermilk.
  • Such foods or food compositions may be prepared in a manner known per se, e.g. by adding the strain(s) of the invention to a suitable food or food base, in a suitable amount (see e.g. WO 01/82711).
  • the strain(s) are used in or for the preparation of a food or food/nutrient composition, e.g. by fermentation. Examples of such strains include probiotic lactic acid producing bacteria of the invention.
  • the strain(s) of the invention may be used in a manner known per se for the preparation of such fermented foods or food/nutrition compositions, e.g. in a manner known per se for the preparation of fermented dairy products using lactic acid producing bacteria.
  • the strain(s) of the invention may be used in addition to the micro-organism usually used, and/or may replace one or more or part of the micro-organism usually used.
  • a live food grade lactic acid producing bacterium of the invention may be added to or used as part of a starter culture or may be suitably added during such a fermentation.
  • a food supplement may comprise one or more carriers, stabilizers, prebiotics and the like.
  • the composition is in powder form, for enteral (preferably oral) administration, although nasal administration or inhalation may also be suitable.
  • enteral preferably oral
  • the cells may be present in an encapsulated form in order to be protected against the stomach.
  • the composition may be in the form of a powder packed in a sachet which can be dissolved in water, fruit juice, milk or another beverage.
  • a nutrition composition preferably comprises carbohydrates and/or proteins and/or lipids suitable for human and/or animal consumption.
  • the compositions may or may not contain other bioactive ingredients, such as other (probiotic) strains, and prebiotics (dietary fibers), which support the probiotic strains.
  • the cells When using living cells of the probiotic bacteria, the cells may be present in an encapsulated form in order to be protected against the stomach.
  • the nutrition is preferably in liquid or powder form.
  • the nutrition is preferably administered enterally, such as orally or by tube feeding.
  • the present composition in one embodiment provides nutrition and comprises a lipid component, a protein component and a carbohydrate component.
  • the lipid component preferably provides 5 to 50% of the total calories
  • the protein component preferably provides 5 to 50% of the total calories
  • the carbohydrate component preferably provides 15 to 90% of the total calories.
  • the total of energy provided by the proteins, peptides and amino acids needs to be taken and the energy provided by digestible carbohydrates.
  • compositions wi ll usually be used for entera l, prefera bly ora l, nasal/inhalation, vaginal or rectal administration.
  • Pharmaceutical compositions will usually comprise a pharmaceutical carrier in addition to the probiotic bacteria. The preferred form depends on the intended mode of administration and (therapeutic) application.
  • the pharmaceutical carrier can be any compatible, nontoxic substance suitable to deliver the strains(s) to the desired body cavity, e.g. the intestine of a subject. E.g. sterile water, or inert solids may be used as the carrier usually complemented with pharmaceutically acceptable adjuvants, buffering agents, dispersing agents, and the like.
  • Pharmaceutical compositions may further comprise additional biologically or pharmaceutically active ingredients.
  • compositions comprising one or more probiotic bacteria according to the invention are suitable to either treat patients already suffering from pulmonary heart disease, in particular pulmonary hypertension or may be administered prophylactically to subjects which are at risk of developing pulmonary heart disease, in particular pulmonary hypertension.
  • pulmonary hypertension was induced in mice by inducing lung emphysema by inhalation of lypopolysaccharide (LPS).
  • LPS lypopolysaccharide
  • mice Specific pathogen free male BALB/c byJlco mice were obtained from Charles River (Maastricht, the Netherlands). Food and water were provided ad libitum and the mice were used when 7-8 weeks of age. All experiments were approved by the animal ethics committee of the University of Utrecht, The Netherlands. LPS from E. coli, serotype O55:B5 was obtained from Sigma.
  • Lung emphysema was induced by intranasal administration of LPS (5 ⁇ g in 50 ⁇ l phosphate buffered saline (PBS)) or, as a control, PBS (50 ⁇ l) twice a week for four weeks (day 0, 3, 7, 10, 10, 14, 17, 21, and 24) followed by two weeks of rest. Mice were treated daily with 0.2 ml PBS containing 10 9 (CFU) per strain lactic acid bacteria orally via gavage. Two different diet protocols were used in three separate experiments (table 1). In treatment protocol I, mice received a probiotic diet from day 14 untill the end of the experiment. In preventive protocol II, mice received a probiotic diet starting 14 days before the first LPS (or PBS) treatment untill the end of the experiment. In protocol III mice were treated with either the preventive protocol or the treatment protocol. Table 1 Diet strategies
  • Hypertrophy of the right ventricular is an indication for pulmonary hypertension.
  • the whole heart (of 4 out of 10 animals) was isolated and the right ventricular free wall (RV) was completely separated and removed under a dissecting microscope at day 42.
  • the left ventricle and septa (LV+S) and RV were weighed separately after blotting dry.
  • the ratio of RV weight to LV+S weight was used as an index of right ventricular hypertrophy.
  • the ratio of heart weight to body weight was used as an index for heart hypertrophy.
  • Results are expressed as arithmetic average ⁇ SEM . p ⁇ 0.05, p ⁇ 0.01 and p ⁇ 0.001 compared with PBS treated mice. * p ⁇ 0.05, ** p ⁇ 0.01 and *** p ⁇ 0.001 compared with LPS-treated mice using Student's t-test.

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Abstract

Cette invention concerne une nouvelle utilisation de bactéries probiotiques, des formes mortes ou non viables de celles-ci, ainsi que des compléments alimentaires, des compositions nutritives et/ou des compositions pharmaceutiques les contenant, pour traiter ou prévenir les pneumopathies chez un sujet. Une bactérie appropriée produisant de l'acide lactique exerce un effet bénéfique significatif sur l'hypertrophie pulmonaire déterminée par la mesure du poids du cœur de l'animal étudié.
PCT/NL2009/050762 2008-12-17 2009-12-14 Probiotiques destinés à traiter et/ou à prévenir l'hypertension pulmonaire Ceased WO2010071421A1 (fr)

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Cited By (8)

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Publication number Priority date Publication date Assignee Title
WO2014083166A1 (fr) 2012-11-29 2014-06-05 Nestec S.A. Composition symbiotique et utilisation correspondante
CN104623588A (zh) * 2014-12-29 2015-05-20 邹德奇 一种治疗稳定期慢性肺源性心脏病的中药组合物
CN104644692A (zh) * 2015-01-28 2015-05-27 董延辉 一种酝养降压液的方法
CN104822277A (zh) * 2012-11-29 2015-08-05 雀巢产品技术援助有限公司 合生元组合物及其用途
WO2019180964A1 (fr) * 2018-03-23 2019-09-26 森永乳業株式会社 Composition favorisant la sécrétion de fgf21
WO2021167088A1 (fr) * 2020-02-21 2021-08-26 良和 中岡 Composition pour soulager l'hypertension pulmonaire, procédé de prédiction du pronostic de l'hypertension pulmonaire, procédé d'aide à la détermination de la gravité de l'hypertension pulmonaire, et procédé d'aide au diagnostic de l'hypertension pulmonaire
CN113368138A (zh) * 2021-06-18 2021-09-10 中国人民解放军总医院 益生菌用于预防和/或治疗高原病
CN117736911A (zh) * 2023-11-28 2024-03-22 金华银河生物科技有限公司 一种短双歧杆菌b-169及其在降血压中的用途

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Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014083166A1 (fr) 2012-11-29 2014-06-05 Nestec S.A. Composition symbiotique et utilisation correspondante
CN104822277A (zh) * 2012-11-29 2015-08-05 雀巢产品技术援助有限公司 合生元组合物及其用途
CN104623588A (zh) * 2014-12-29 2015-05-20 邹德奇 一种治疗稳定期慢性肺源性心脏病的中药组合物
CN104623588B (zh) * 2014-12-29 2018-05-01 黑龙江中医药大学 一种治疗稳定期慢性肺源性心脏病的中药组合物
CN104644692A (zh) * 2015-01-28 2015-05-27 董延辉 一种酝养降压液的方法
CN111936155B (zh) * 2018-03-23 2023-08-18 森永乳业株式会社 促进fgf21分泌用组合物
CN111936155A (zh) * 2018-03-23 2020-11-13 森永乳业株式会社 促进fgf21分泌用组合物
JPWO2019180964A1 (ja) * 2018-03-23 2020-12-03 森永乳業株式会社 Ｆｇｆ２１分泌促進用組成物
JP7152472B2 (ja) 2018-03-23 2022-10-12 森永乳業株式会社 Ｆｇｆ２１分泌促進用組成物
AU2018414925B2 (en) * 2018-03-23 2023-05-04 Morinaga Milk Industry Co., Ltd. Composition for promoting the secretion of FGF21
WO2019180964A1 (fr) * 2018-03-23 2019-09-26 森永乳業株式会社 Composition favorisant la sécrétion de fgf21
US11857579B2 (en) 2018-03-23 2024-01-02 Morinaga Milk Industry Co., Ltd. Composition for promoting the secretion of FGF21
WO2021167088A1 (fr) * 2020-02-21 2021-08-26 良和 中岡 Composition pour soulager l'hypertension pulmonaire, procédé de prédiction du pronostic de l'hypertension pulmonaire, procédé d'aide à la détermination de la gravité de l'hypertension pulmonaire, et procédé d'aide au diagnostic de l'hypertension pulmonaire
EP4108260A4 (fr) * 2020-02-21 2024-03-06 JSR Corporation Composition pour soulager l'hypertension pulmonaire, procédé de prédiction du pronostic de l'hypertension pulmonaire, procédé d'aide à la détermination de la gravité de l'hypertension pulmonaire, et procédé d'aide au diagnostic de l'hypertension pulmonaire
CN113368138A (zh) * 2021-06-18 2021-09-10 中国人民解放军总医院 益生菌用于预防和/或治疗高原病
CN117736911A (zh) * 2023-11-28 2024-03-22 金华银河生物科技有限公司 一种短双歧杆菌b-169及其在降血压中的用途

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