prehistory terminology probiotics/prebiotics lactulose food fibers enterosorbents ligninlactofiltrum...
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Prehistory terminology
Probiotics/Prebiotics Lactulose
Food fibers Enterosorbents Lignin LactofiltrumLactofiltrum
Probiotics are beneficial bacteria that can be introduced into the digestive system with food. They enhance immunity, help regulate hormone balance, protect from food poisoning, allergies, and perform other important functions.
Prebiotics are non-digestible carbohydrates that pass through the small intestine undigested and are fermented in the colon by beneficial bacteria thus activating their growth.
Enterosorbents are substances that bind and deduce exogenous and endogenous toxins as well as pathogenic microorganisms and their metabolites from the gastrointestinal tract .
Composition
Medicinal lignin fibers, mg 375,0
Lactulose, mg 125,0
Moisture, % 5, 0
Total tablet weight, mg, + 5%
500,0
Shelf life: 3 years
Lactofiltrum is patented in 1999. Expiry date 2019
Specification of components:
Medicinal lignin by Russian manufacturers standard (approved by the Ministry of Health) FSP 42-02363083-02
Lignin active substance and Lactofiltrum (as finished product) are manufactured on the own plant in accordance with GMP standards. Lignin modified preparation technology and sterilization were elaborated on the basis of the own patent (1999).
Lactulose (complies with Lactulose Concentrate USP26)
New generation prebiotic for elimination of intestinal pathogenic microorganisms and their toxins as well as for activation of own bifidobacteria growth, which normalizes microflora balance Dysbacteriosis of different etiology (gastro-
intestinal chronic and acute diseases, long-term therapy by anti-inflammatory non-steroids, immunosuppresants etc.)
Irritated bowel syndrome with a tendency to constipation and unstable stool
Rehabilitation of microflora disbalance after antibiotic therapy (incl. antibiotic-associated diarrhea)
In complex therapy of atopic dermatitis (diathesis) particularly in pediatric practice
Combined treatment of acute and chronic viral hepatitis and hepatic cirrhosis.
General improvement of intestinal microbiological ecology (for aging population)
Indications:
Dysbacteriosis or microflora disbalance
Vital aspects of abnormal microflora in children
Dysbacteriosis or microflora disbalance:
Microflora disorders are diagnosed in 90% children
Slows down vitamins and minerals absorption thus negatively affecting development of bone, muscle and nervous systems as well as immunity
Often causes or aggravates atopic dermatitis
Has negative destructive influence on the intestinal mucosa causing various gastro-intestinal chronic diseases
Vital aspects of normal microflora in adults and aged peopleNormal microflora
Prevents septic processes in intestines and colon
Results in decreasing internal intoxication
Improves absorption of vitamins and minerals preventing osteoporosis
Has beneficial effect on immunity and general physiological activity
FeaturesDOUBLE MECHANISM INFLUENCE ON MICROFLORA
Lactulose - improves growth and activity of lacto - and bifidobacteria
Lignin - natural enterosorbent, adsorbs wide range of endo- and exogenous toxins and pathogenic microorganisms in the intestines
100 %
Normalization of intestinal microflora
Аdvantages vs traditional probiotic therapy
LACTOFILTRUM®
(as prebiotic)
Bacterial colonies products (probiotics)
Direct absorption of pathogenic microflora and its toxins
Unable to absorb pathogens
Free transit through gastro-intestinal tract with minimum efficacy loss
Substantial loss of activity in intestines due to interference with aggressive stomach excretion
Direct stimulation of own normal microflora growth
Binds histamines and food allergens (in allergo-dermatosis
therapy) High safety profile: can be used for a long time without side
effects
Ideal as preventive (prophylactic) means
Indirect influence on the normal microflora growth
Unable to bind toxic organic metabolites
Restrictions for durable usage
Prophylactic usage with cautions
Сlinical evidence Treatment of dysbacteriosis in children,
including those with functional and chronic gastrointestinal disturbances
0
10
20
30
40
50
60
70
80
Lactofiltrummonotherapy
Standard therapy(spasmolitics,
probiotics)
constipation
abdom. pain
meteorism
Fig. 1 Improvement of clinical condition (treatment duration 14 days)
Effi
cacy
, % p
atie
nts
Research Institute of Pediatrics (Moscow, 2003)
Lactofiltrum influence on intestinal microflora
Microflora compositionNormal
level
With Lactofiltrum (n = 45)
Control (n = 15)
Before After Before After
Bifidobacteria > 8 < 6 > 9 < 7 < 7
Lactobacteria > 6 < 5 > 8 < 5 6
E.coli, weak fermentative < 10 % 13% 5% 12% 9%
Hemolytic E.coli 0 5 0 6 2
Candida < 3 > 5 0 > 5 < 4
Lactase-negative bacteria < 5 % 7% 3% 7% 5%
Enterococcus < 7 > 9 < 3 > 8 < 3
Fig. 2
Research Institute of Pediatrics (Moscow, 2003)
DOSAGES:
Children under 6 months - 1/4 tablet 3-4 times a day
6 months - 1 year - 1/3 tablet 3-4 times a day
1-3 years - 1/2 - 1 tablet 3 times a day
4-7 years - 1 - 1,5 tablets 3 times a day
over 7 years - 2 tablets 3-4 times a day.
1-1,5 hours before or 1-1,5 hours after meal.
Lactofiltrum treatment resulted in normalization of intestinal microflora composition, namely, in elimination of opportunistic bacteria, suppression of cocci and growth of Lacto- and Bifidobacteria.
CONCLUSIONS
Сlinical evidence
CONCLUSIONS (cont.)
Lactofiltrum corrects both intestinal peristalsis and intestinal microflora composition.
Lactofiltrum is effective in pediatric patients with functional gastrointestinal disturbances like
Lactofiltrum can be used for conditioning therapy to enhance the effect of further decontamination against parasitic invasion (lambliasis)
Lacto- and Bifidobacteria-containing drugs can be reasonably used after 14-day conditioning by Lactofiltrum.
At least 14-day treatment by Lactofiltrum with further analysis of feces for dysbacteriosis appears obligatory after children are transferred from hospital to an orphanage. This measure aims at prevention of nosocomial infection in weak children by opportunistic microflora.
Lactofiltrum clinical study in patients with dysbacteriosis Dynamics of clinical symptoms during Lactofiltrum treatment
0%
20%
40%
60%
80%
100%
120%
Beforetreatment
1-st week oftreatment
2-nd week oftreatment
Appetite
Meteorism
Constipation
Unstable stool
RESULTS:
Improvement of clinical signs was associated by alleviation of intestinal dysbacteriosis.
State Medical University (Saratov, 2005)
0
2
4
6
8
10
12
14
skin hyperemia skin pruritis skin dryness
Lactofiltrum + standardtherapy
Standard therapy (diet,antihistamins, topicals,enzymes)
Conclusions:
Lactofiltrum can be recommended for monotherapy of mild atopic dermatitis in the phase of incomplete remission of moderate disease, and for treatment of moderate atopic dermatitis in combination with local therapy.
Atopic dermatitis accompanied by intestinal disturbance with a tendency to constipation and unstable stool
Treatment duration 14 daysDays
Scientific Center of Children Health (Moscow, 2003)
Acute viral hepatitis (A, B, C)
02468
1012
Lactofiltrumtreatment
Control group
Duration of the major clinical signs
Lactofiltrum addition to standard therapy of acute viral hepatitis results in significantly lesser duration and intensity of intoxication (fatigue, headache, low appetite, anorexia, fever), dyspepsia, pain and jaundice. Such
treatment is shown to accelerate normalization of liver and thickened gallbladder wall sizes and gallbladder clearance of the solids compared to control patients.
Federal Medico-Biological Agency (Moscow, 2005)
Days
Treatment duration 21 days
0
1
2
3
4
5
6
7
8
1 2 3 4
0
1
2
3
4
5
6
7
8
1 2 3 4
Intestinal microflora components in patients with genitourinary chlamydiosis (lg CFU/g).
Control group: clarithromycin Experimental group: clarithromycin + Lactofiltrum
Before treat.
After treat.
1 - Lactobacillus spp.
2 - Bifidobacterium spp.
3 - Escherichia coli4 - Enterococcus spp.
Microflora support during oral antibacterial therapy
Institute of Epidemiology and Microbiology (St.-Petersburg)
RESULTS• Decrease of lactobacilli and bifidum bacteria content was statistically significant in the control group (р<0.001 and p< 0.05 respectively).• Analysis did not reveal significant qualitative alteration of the studied microflora components in experimental patient group.
CONCLUSIONS
1. The study confirmed the efficacy of prebiotic Lactofiltrum administration for prevention of dysbacteriosis development during chlamydiosis treatment by macrolide antimicrobial clarithromycin.
2. Lactofiltrum administration concomitantly with antimicrobial treatment of chlamydiosis facilitates preservation of normal intestinal microflora and decreases the risk of intestinal colonization by Candida spp.
3. Lactofiltrum administration decreases the risk of antimicrobials-induced dyspepsia and allergic reactions.
Lactofiltrum prevention of intestinal dysbacteriosis in surgical patients with purulent conditions receiving prolonged antimicrobial therapy (by CEPHAZOLIN, IMIPENEM, MAXIPIME)
Dysbacteriosis parameters
Study group Control group
Before treatment
After treatment
Before treatmen
t
After treatmen
t
Bifidobacteria (<107) 10% 5% - 20%
Lactobacteria (<105) 5% 5% - 30%
Lactose-negative E. coli (> 5%) 5% - 50%
E. coli with low enzyme activity (> 10%) 10% 5% - 30%
Hemolytic E. coli 5% - 40%
Proteus spp. (>103) 10% - 30%
Staphylococcus aureus 20% - 40%
Military hospital №42 (St.-Petersburg)
Microflora support during parenteral antibacterial therapy
RESULTS
Potential prolonged antimicrobial therapy results in intestinal dysbacteriosis, decrease of bifidobacteria and lacrobacteria content and appearance of opportunistic and pathogenic microflora, including Candida spp.
Lactofiltrum administration allows prevention of intestinal dysbacteriosis during antimicrobial therapy.
Lactofiltrum administration decreases the risk of Candidosis development during antimicrobial therapy.
Lactofiltrum administration allows normalization of gastrointestinal tract condition even in patients with initial dysbacteriosis – normalization of microflora profile, stool frequency and consistence, pain, discomfort and meteorism relief.
CONCLUSION Lactofiltrum inclusion into combined therapy schedule significantly
alleviates both clinical and laboratory manifestations of dysbacteriosis during prolonged parenteral antimicrobial therapy.
Sales dynamics, Russia
0
200 000
400 000
600 000
800 000
1 000 000
1 200 000
1 400 000
packs N60
2001 2002 2003 2004 2005 2006
Positioning: key messages aspects
Double power prebiotic for improvement of
intestinal microflora in case of gastrointestinal
disorders and atopic dermatitis High safety profile prebiotic for all groups of
population Microflora protector during antibiotic therapy Strengthens standard therapy efficacy in case of
microflora disorders (synergy)
R & D prospectsR & D prospects
Product improvement for children audience: confectionery, powders, various tastes
Miscellaneous formulations: caplets, capsules, sache, gel, paste
Combination with additives giving synergy positive effect for intestinal microflora
Modifying prebiotic component to reach better activation of definite spp.
Modifying enterosorbent component to gain more specific absorption of certain pathogens
Representação no Brasil:
R. Dr. Cândido Espinheira, 350 – 13° andar – Cj. 132
CEP 05004-000 – São Paulo/SP
Fone 55 11 3676-0546 / FAX 55 11 3676-0559