Index. B Bacitracin Lactobacillus acidophilus, 70 pyelonephritis, 246 Antifungals

Transcription

1 A AAD, see Antibiotic-associated diarrhea Absorption Bifidobacterium species animals,67 humans,67 biotherapeutic agents, 47 Lactobacillus species, 61 Saccharomyces boulardii animals, 50, 51 humans,57 Absorption, distribution, metabolism, and excretion (ADME) studies, Acidic medium survival bacterial biotherapeutic agents, 29 Action mechanisms bacterial biotherapeutic agents, Saccharomyces boulardii, Action site biotherapeutic agents, 47 Acute diarrhea, 47 Acute toxicity studies, 11 Adenylate cyclase Vibrio cholerae, 34 Adherence competition vagina, 228 Adhesion, and lactic acid bacteria (LAB), 296, 297 ADME, see Absorption, distribution, metabolism, and excretion Administration bacterial biotherapeutic agents, 28,29 biotherapeutic agents, 47, 48 Adult diarrhea, biotherapeutic agents, Age, and Clostridium difficile disease, 164 Aminoglycoside Bifidobacterium species, 71 t Lactobacillus species, 65t. Ampicillin, 70 Lactobacillus species, 62-64, 66 Anaerobic Gram-positive cocci normal vaginal flora, 224 Anion-exchange resins, and 173, 174 Antibacterial ehect Bifidobacterium species, 7lt Antibiotic-associated diarrhea (AAD), 47, 146 adults, 211, 212 Bifidobacterium species, 151, 152 biotherapeutic agents, , 148t 305

2 306 Enterococcus faecium SF68, 152 Lactobacillus acidophilus and bulgaricus, 150, 151 Lactobacillus GG, oral biotherapy, 213t, 214t pediatrics, 198 prevention, Streptococcus faecium SF68, 152 Antibiotie effects Lactobacillus species, Antibiotie resistance, 22 biotherapeutic agent risks, 266, 267 Enterococcus faecium SF68, 70 animals,72 humans, 72, 73 Lactobacillus species, 64 Antibiotics Enterococcus faecium SF68, 72t and Saccharomyces boulardii humans,59 urinary tract infection (UTI), Antibiotic treatment, Lactobacillus acidophilus, 70 pyelonephritis, 246 Antifungals and Saccharomyces boulardii animals,57 humans,59 Antimicrobials Antimicrobial substance production, and bacterial biotherapeutic agents, 30 Arthritis 169 ATCC53103 intestinal microflora, ATCC intestinal mieroflora, Atrophie vaginitis, 236, 237 Azithromycin Lactobacillus species, 64t B Bacitracin Bacterial biotherapeutic agents action mechanisms, administration mode, 28, 29 antimicrobial substance production,30 colonization resistance, 29, 30 competitive inhibition, 30, 31 immune system stimulation, 31,32 pharmacokinetics, 29 Bacterial vaginosis biotherapeutie agent therapy, Lactobacillus isolation, 228 Benzylpenieillin Lactobacillus species, 64, 66 Beta-lactam Bifidobacterium species, 71t Bifidobacterium bifidum, intestinal mieroflora, 100 and Lactobacillus acidophilus, 110 Bifidobacterium longum, 28-31, 128 and Enterococcus faecium SF68, 110 intestinal microflora, 98 Bifidobacterium species (AAD), 151, 152 antibacterial effect, 71 t

3 human gastrointestinal mieroflora, 99t and Lactobacillus species human gastrointestinal mieroflora, 102t, 103t pharmacokineties, animals, 66, 67 humans, Bifidobacterium strains intestinal microflora, 100, 101 and Lactobacillus strains intestinal mieroflora, Biliary stents biotherapeutie agents, 255, 256 Bioflorin (AAD),152 pharmacokineties, Biologieal media tors lactic acid bacteria (LAB) producer, 278, 279 Biologie characteristies, 15 Biologie development biotherapeutie agents, 9-21 Biologie license application (BLA), 2, 19 outline for biotherapeutie agents, 20t, 21t Biotherapeutie agent development, and urinary tract infection (UTl), Biotherapeutie agent impact normal oral mierobial flora, 110, 111 normal vaginal mierobial flora, Biotherapeutie agent interference immune system, Biotherapeutie agents action mechanisms history, applications pharmacokineties, 47 biologie development, 9-21 characteristies, 3t development, 9-21 biologie license application, 19 c1inical studies, marketing, postmarketing safety studies,19 prec1inical studies, distinguishing between, 8 future directions, history, 2 human multiple-dose studies, 16t immunologieal effects, immunomodulation, 125, 126 normal gastrointestinal mierobial flora, pharmacokineties, quality control issues, regulating laws, 2, 3 regulations, 1-8 risks, safety,6 Biotherapeutie agents adverse effects immunodeficient subjects, 136, 137 Biotherapeutic agent therapy Lactobacillus selection, BLA, see Biologie license application Bladder infections, treatment and prevention of, Blood, and Lactobacillus GG, 264 Breast-feed infants, 147 Broad -spectrum antimierobial agents, 229 Brush-border membrane vesic1es endoluminal polyamines, 40

4 308 c camp production, 34 Candida albicans, 34, 37 Candida krusei, 34 Candida pseudotropicalis, 34 Candida vaginitis, 47 biotherapeutic agent therapy, and antibiotic therapy, 231 Lactobacillus therapy, 231 Cefoperazone Cefpiramide Ceftazidime Cefuroxime lactobacillus species, 64, 66 Cephalosporin Bifidobacterium species, 71 t Lactobacillus species, 65t Chronic toxicity, 11, 12 Clarithromycin Lactobacillus species, 64t Clindamycin Lactobacillus species, 63, 64 Clostridium botulinum, 145 Clostridium difficile, 30, 35, 36, 104, 145, 146, 149 Clostridium difficile diarrhea, 47 pediatrics, 197, biotherapeutic agents, comorbidity, 161 costs, 160, 161 diagnosis, 170, 171 epidemiology, 162 exotoxin production, 170 frequency, 160 mortality, 161, 162 pathophysiology, 169, 170 prevalence and incidence, 163t risk factors, spectrum, standard treatment, Clostridium tetani, 145 Code of Federal Regulations, 2, 4, 8 Coleus forskolii, 35 Colitis, Clostridium difficile disease and,165 Colonic food, 73 Colonization Enterococcus faecium SF68 humans and animals, 73 lactic acid bacteria (LAB), 296 lactobacilli, 60, 61 Colonization resistance bacterial biotherapeutic agents, 29,30 Colonization sites Bifidobacterium species animals, 66, 67 Common mucosal immune system, 122 Competitive inhibition bacterial biotherapeutic agents, 30,31 Saccharomyces boulardii, 33, 34 Crohn's disease, 132 Cystitis prevention women, Cytokine production modulation, 126, 127 D Desquamative inflammatory vaginitis, 236 Destruction and cell death biotherapeutic agents, 48

5 Diarrheal disease adults, pediatric prevention, pediatrics, pediatric treatment, 199, 200 Dietary fibers and Saccharomyces boulardii animals,57 humans,59 Dietary Supplement Health and EducationAct (DSHEA), 2, 5, 8 Dietary supplements, 4-6 characteristics, 3t DSHEA definition and criteria, 5 Digestive tract conditions lactic acid bacteria (LAB) metabolism, Distribution biotherapeutic agents, 48 Saccharomyces boulardii animals, Dose, 22 Dose relationships Saccharomyces boulardii animals, 51, 53, 54, 56 humans, 58, 59 Dose studies biotherapeutic agents, 16t Drug application, 2 DSHEA, see Dietary Supplement Health and Education Act E Elimination biotherapeutic agents, 48 Endogenous fecallevels antibacterial effect Bifidobacterium species, 71 t Endoluminal polyamines brush-border membrane vesicles, Endotracheal tubes biotherapeutic agents, 256 Enoxacin Lactobacillus species, 63 Entamoeba histolytica, 33 Enteric infections biotherapeutic agents, Enterobacteriaceae normal vaginal flora, 224 Enterococcus faecium SF68, (AAD),152 antibiotics, 72t and Bifidobacterium longum, 110 biological properties, intestinal microflora, 106, 108 pharmacokinetics, and Saccharomyces boulardii gastrointestinal microflora, 107t Enzymes, as lactic acid bacteria (LAB) producers, 278 Erythromycin Lactobacillus species, 64t Escherichia coh, 30, 35, 36, 129, 152 Excretion Bifidobacterium species humans,68 biotherapeutic agents, 48 Lactobacillus species, 62 Saccharomyces boulardii animals, 52, 53 humans,58 Exotoxin production 170 F FDA, see Food and Drug Administration Fecal recovery, oligosaccharides as biotherapeutic agents in, 74 Saccharomyces boulardii, 53f

6 310 Federal Trade Commission (FTC), 6,8 Fermented milks, 29 Food and Drug Administration (FDA), 2, 8 Orphan Drug amendments of 1988,7 Food products urinary tract infection (UTI), 248,249,255 Foods characteristics functional, 3t medical,3t Food strains lactic acid bacteria (LAB), 273 Formulation,22 FTC, see Federal Trade Commission Functional foods, 2, 6-8 characteristics,3t Function claims, 5 Fungemia Saccharomyces boulardii, 264 G GALT, see Gut-associated lymphoid tissue Gastric acid, and lactobacilli, 60 Gastrointestinal immune system, 122 ingested biotherapeutic agents, Gastrointestinal manifestations 166, 167 Gastrointestinal microbial flora, normal biotherapeutic agents, Gastrointestinal microflora Bifidobacterium and Lactobacillus species, 102t, 103t Bifidobacterium species, 99t Lactobacillus species, 90t, 91 t Saccharomyces boulardii and Enterococcus foecium SF68, 107t Gastrointestinal tract (GIT), 122 Gender 164, 165 Gene acquisition, 22 Gentamycin Lactobacillus species, 64, 66 GIT, see Gastrointestinal tract GI tract colonization Saccharomyces boulardii animals, Gram-negative antibacterials Lactobacillus species, 63 Gram-negative rods normal vaginal flora, 224 Gram-positive antibacterials Lactobacillus species, 63, 64 Gram-positive cocci normal vaginal flora, 223, 224 Growth conditions Enterococcus faecium SF68, 70 Gut-associated lymphoid tissue (GALT),122 inductive arm, 122, 123 Gut immune system ingested biotherapeutic agents animals, humans, 132 intestinal flora, 124 H Herbai products, 5 Heterologous protein expression lactic acid bacteria (LAB), Hormones, lactic acid bacteria (LAB) producer of, 278, 279

7 311 Hydrogen peroxide bacterial antagonism, 228, 229 Identification of strain, 21, 22 Immune cells biotherapeutic agents, 126, 127 Immune response ingested biotherapeutic agents, 129, 130 Immune system biotherapeutic agent interference, intestinal tract, Immune system stimulation bacterial biotherapeutic agents, 31,32 Saccharomyces boulardii, 36, 37 Immunodeficient subjects biotherapeutic agents adverse effects, 136, 137 Immunoglobulin treatment 174 Immunological effects biotherapeutic agents, Immunomodulation biotherapeutic agents, 125, 126 IND, see Investigational new drug Inducing agent discontinuation 171 Ingested biotherapeutic agents GALT, 124, 125 gastrointestinal immune system, immune response, 129, 130 systemic immunity, Interleukins lactic acid bacteria (LAB) producer, 278, 279 Intestinal flora gut immune system, 124 Intestinal microflora Bifidobacterium and Lactobacillus strains, Enterococcusfoecium SF68, 106, 108 Lactobacillus acidophilus, Lactobacillus casei GG, radiotherapy, 216 Saccharomyces boulardii, yeast, Intestinal mucosa radiotherapy,216 Intestinal mucosal immune system regulation, 123, 124 Intrauterine devices biotherapeutic agents, 255, 256 Investigational new drug (lnd) application, 10 L LAB, see Lactic acid bacteria Lactacin B, 229 Lactie acid bacteria (LAB) beneficial effects, description, 270, 271 digestive tract animals, humans,276 food strains, 273 genetic approaches, heterologous protein expression, metabolie activity, 297 new moleeule producer, physiological states, safety,271 Lactic acid bacteria (LAB) metabolism digestive tract conditions, Lactic acid bacteria (LAB) transit,

8 312 Lactinex, antibiotic-associated diarrhea (AAD) and, 150, 151 Lactobacillus acidophilus, 7, 28-31, 60, 128 (AAD), 150, 151 and Bifidobacterium bifidum, 110 intestinal microflora, Lactobacillus bulgaricus, 60 antibiotic-associa ted diarrhea (AAD), Lactobacillus casei GG, 28-31, 60 intestinal microflora, Lactobacillus gasseri intestinal microflora, 96 Lactobacillus genus normal vaginal flora, 223 Lactobacillus GG (AAD), biotherapeutic agent risks, 264 Lactobacillus plantarum, 60 Lactobacillus reuteri intestinal microflora, Lactobacillus rhamnosus, 7 (AAD), Lactobacillus rhamnosus GG Lactobacillus species antibacterial effects, 65t bacterial vaginosis, 235 and Bifidobacterium species human gastrointestinal microflora, 102t, 103t human gastrointestinal microflora, 90t, 91 t Listeria monocytogenes, 128 normal vaginal microflora, pharmacokinetics, urinary tract infection (UTI), vagina immune system stimulation, 229 Lactobacillus species selection biotherapeutic agent therapy, Lactobacillus strains and Bifidobacterium strains intestinal microflora, intestinal microflora, 97 Lactobacillus therapy Candida vaginitis, 231 Lactocidin acidolin, 229 Leukocyte function modulation, 128 Listeria monocytogenes Lactobacillus species, 128, 129 Liver abscess Saccharomyces cerevisiae, 265 Living drugs, 47 Living microorganism capsules dried and powdered, 29 Lower gastrointestinal microflora, 87 Lower genital tract infections prevention, 237, 238 Low urinary ph, and urinary tract infection (UTI), 248 Low vaginal ph, 227, 228 Lymphocyte proliferative response modulation, 128 Lymphocytes, 121 Lymphoid aggregates, 122 Lyophilized preparations Saccharomyces boulardii, 39t Lysis lactic acid bacteria (LAB) transit,

9 313 M Macrolide Bifidobacterium species, 71 t Lactobacillus species, 65t Macrolide antibiotics Lactobacillus species, 64t MALT, see Mucosa-associated lymphoid tissue Mass balance principle, 47 Medical devices biotherapeutic agents, 255, 256 Medical foods, characteristics, 3t Meningitis Lactobacillus species, 64, 66 Metabolie activity lactic acid bacteria (LAB), 297 Metronidazole bacterial vaginosis, 234 Microbial flora, normal composition, influences on, Microbial replacement treatment 174 Microflora establishment, 85, 86 human investigational problems in, 89 importance, 88, 89 Movement Saccharomyces boulardii animals, 50, 51 Mucosa-associated lymphoid tissue (MALT), 122 Mucosal surface adhesion lactic acid bacteria (LAB), 296, 297 Mutagenicity testing, 12 N Natural products, 5 NDA, see New drug application Neonates Lactobacillus species, 64, 66 New drug application (NDA), 19 Normal gastrointestinal microbial flora biotherapeutic agents, Normal microbial flora composition, influences on, Normal vaginal flora, his tory, 222, 223 Lactobacillus genus, 223 organism, 223, 224 Normal vaginal microbial flora biotherapeutic agent impact, Nutraceutical, 6, see also Functional foods o Oligosaccharides, 73 biotherapeutic agent fecal recovery, 74 Omphalitis Oral biotherapy (AAD), 213t, 214t Oral vaccines lactic acid bacteria (LAB) producer, 277, 278 Oropharyngeal flora, 86 Oropharyngeallevels Lactobacillus species, 60 Orphan Drug amendments of 1988, FDA and, 7 p Packaging, 22, 23 Parenteral administration effects biotherapeutic agents, 128, 129

10 314 PBMC, see Peripheral blood mononuclear cells Pediatrics diarrheal disease, probiotics role, 196, 197 Pelvic radiotherapy biotherapeutic agent influence, 216 Penicillin Bifidobacterium species, 71 t Lactobacillus species, 65t Penicillin G Peripheral blood mononuclear cells (PBMC), 126, 127, 132 Peritoneal catheters biotherapeutic agents, 255, 256 Peyer's patches, 122 Pharmacokinetics bacterial biotherapeutic agents, 29 Saccharomyces boulardii, 32, 33, Phase 111 studies, Phase 11 studies, 17 Phase I studies, Plasmid acquisition, 22 Pneumonia Saccharomyces cerevisiae, 265 Polyamines, 38, 39 Polysaccharides, 73 Population levels, lactic acid bacteria (LAB) transit, Potency,23 Prebiotic, 27 Prebiotic effects biotherapeutic agents, 73, 74 Probiotic, 27 Probiotics role pediatrics, 196, 197 Pseudomembranous colitis, 166, 167 Pseudomonas aeruginosa, 129 Purity,23 Putrescine, 39t Pyelonephritis, 245 antibiotic therapy, 246 Q Quality control issues biotherapeutic agents, Quinolone Bifidobacterium species, 71 t R Radiotherapy intestinal microflora, 216 Radiotherapy-associated diarrhea prevention of, 217t Rectal biotherapy inoculates, 28 Reproduction biotherapeutic agents, 47 Reproductive studies, 12 Respiratory tract infection Risk factors Risks biotherapeutic agents, reported, theoretical, s Saccharomyces boulardii, 28 action mechanisms, competitive inhibition, 33, 34 immune system stimulation, 36,37 pharmacokinetics, 32, 33

11 toxin antisecretory effects, 34,35 toxin binding inhibition, 35, 36 toxin receptor site inactivation, 34, 35 trophic effects on intestinal mucosa,37-41 (AAD), biotherapeutic agent risks, and Enterococcus faecium SF68 gastrointestinal microflora, 107t intestinal microflora, lyophilized preparations, 39t pharmacokinetics, animals, humans, Saccharomyces cerevisiae biotherapeutic agent risks, 265 Safety biotherapeutic agents, 6 Salmonella typhimurium, 129 Saturable absorptive process, 40 Scale-up problems, 22 Sepsis biotherapeutic agent risks, Saccharomyces cerevisiae, 265 Septicemia 169 Lactobacillus species, 64, 66 Shigellosis, 216 Skin flora, 88 Small intestinal mucosa, 40 Spermicidal agents urinary tract infection (UTn, 247 Spermidine, 39t Spermine, 39t T 315 Spiramycin Lactobacillus species, 64t Stability strain, 21, 22 Strain stability and identification, 21,22 Streptococcus faecium, see Enterococcus faecium SF68 Streptococcus faecium SF68 (AAD),152 Streptococcus thermophilus, Structure claims, 5 Subchronic toxicity, 11 Survival Bifidobacterium species humans,68 biotherapeutic agent risks, 265 lactic acid bacteria (LAB) transit, , 297 Lactobacillus species, Systemic immune compartment biotherapeutic agents, Systemic immune system, 122 Systemic immunity ingested biotherapeutic agents animals, 133, 134 humans, Toxin antisecretory effects Saccharomyces boulardii, 34, 35 Toxin binding inhibition Saccharomyces boulardii, 35, 36 Toxin receptor site inactivation Saccharomyces boulardii, 34, 35 Translocation, see Absorption biotherapeutic agent risks, 266 Traveler's diarrhea, 47 adults, pediatrics, 198 prevention,

12 316 Trophic effects on intestinal mucosa Saccharomyces boulardii, (] Upper gastrointestinal microflora, 86, 87 Urethral syndrome, 245 Urinary catheters biotherapeutic agents, 256 Urinary tract infections (UTI), 47 biotherapeutic agent development, treatment and prevention, women, UTI, see Urinary tract infection V Vagina adherence competition, 228 physiological conditions, 226t Vaginal clindamycin therapy, 236 Vaginal flora, 88 influencing factors, 227t Vaginal flora, normal, Vaginal microbial flora, normal biotherapeutic agent impact, Vaginitis therapy biotherapeutic agents, Vancomycin Vibrio cholerae adenylate cyclase, 34 Voice prostheses biotherapeutic agents, 256 y Yeast intestinal microflora, normal vaginal flora, 224