probacti sachets and capsulesprobacti.pl/probacti 2010.pdf · probiotics and their history? pr elie...

Property of Institut Rosell - Confidential

PROBACTI

Sachets and capsules


GUT MICROFLORA

•400-500 different bacterial species

•1011 bacterial cells/g of colon

Healthy bacteria protect from pathogens


GUT MICROFLORA


Change in comensal flora with ageing


Intestinal flora is in close contact with intestinal

immune system trough the intestinal epithelial cells

Lamina

Propria

Intestinal Lumen

Intestinal flora

Immune cells

Intestinal

epithelial

cells

M cell


Intestinal Microflora

• Intestinal Distress

(eg. pain, diarrhea, bloating,

flatulance…)

• Allergic Reactions

(eg. food allergies, eczema)

• Intestinal Diseases

(eg. IBS, IBD, ulcers, cancers…)

A delicate equilibrium

• Gastric Acid

• Bile salts

• Changes in diet

• Stress

• Antibiotics

• Ageing

• Ingestion of pathogens

Microflora

Intestinal

immune

system


HOW DOES IT WORK?

10E+11

10E+09

CFU/g

Disturbance

Pathogens

Friendly bacteria


THE PROBIOTICS CONCEPT?

Bulgarian people are living longer

than other populations in Europe

Metchnikoff 1910

?


THE PROBIOTICS CONCEPT?

As…

• They were eating yogurt

• They were eating living bacteria

• Those bacteria could excert a positive effect in neutralizing

the negative effect of endogenous microfora flora


PROBIOTICS AND THEIR HISTORY?

Pr Elie Metchnikoff isolates Lactobacillus bulgaricus from bulgarian yoghurt

1904 1923

Henri Boulardii isolates a variant of Saccharomyces cerevisiae from litchi in Vietnam

1965

Stillwell and Lilly introduce the word « probiotics » as substance or organism which contributes to intestinal balance

2001

FAO/WHO probiotic definition


Probiotic definition

FAO/WHO recommended definition for Probiotics:

‘Live microorganisms which when administered in adequate amounts

confer a health benefit on the host’

Pro (pro) = « in favor of »

Bios (bios) = « life »


PROBIOTIC MICRO-ORGANISMS?

• Bacteria : especially lactic acid bacteria

L. acidophilus, L.helveticus, L.rhamnosus, L. casei, L.plantarum, B.bifidum, B.longum, B.breve, B.infantis, E.faecium

• Yeast : Saccharomyces boulardii


WHAT MAKES A GOOD PROBIOTIC?

• Be safe for the consumer

• Contains live micro-organism

• Resist to storage conditions

– Process technology to stabilize bacteria for long-term storage

• Remain alive in the gut

– Resist gastric acid and bile

• Have proven efficacy

– Documentation on pharmacodynamics, pharmacokinetics and clinical efficacy.


Institut Rosell commitment to quality

• Expertise in probiotics since 1934

• Worldwide recognized as the leader in the probiotic supplement field

• Awards in 2001 and 2002 for its innovative technology


Institut Rosell, pioneer in probiotic solutions

Dr. Jose Maria Rosell, a precursor….

• Dr. Jose Maria Rosell, founder in 1934

• Spanish Physician and post graduated in Microbiology

• Introduction of the Yoghurt in North America

Institut Rosell, pioneer in probiotic solutions

• Mission: to study, develop and produce probiotic

formulations targeting specific health conditions

• Products distributed either under Institut Rosell’s own

trademark or via major players of the food supplement

industry or pharmaceutical companies (consumer

healthcare division) worldwide.

1934

1998


PROBACTI presentation

• PROBACTI design

• Probiotic’s selection criteria

• Institut Rosell know how and proprietary technology for

probiotic stability

•PROBACTI: features and benefits

Institut Rosell quality commitment


• A multi-strain probiotic product

Lactococcus Rosell-1058 ssp. lactis

Lactobacillus casei Rosell-215

Lactobacillus acidophilus* Rosell-52

Bifidobacterium bifidum Rosell-71

+ FOS only in sachets form

• Selected and efficient strains

PROBACTI

Dietary supplement

* Reclassified as helveticus

Capsules form

Sachets form


PROBACTI design

• Strain selection: number, species, dosage

• Origin

• Resistance to gastric acidity

• Resistance to bile salts

• Adhesion to intestinal epithelial cells

• Health benefits

• Production’s criteria

Probiotic’s selection criteria


Strain choice: which species ?

Repartition of healthy bacteria in the GIT

1

2

3

4

5

6

7

8

9

10

11

1 2 3 4 5 6 7 8

Co

nce

ntr

ati

on

lo

g C

FU

/g

Lactobacillus andLactococcus

Bifidobacterium

Mouth Estomac Duodenum Jejunum Ileum Caecum Rectum


Evolution of the bacterial species in the

GI tract depending on the age of life

0

2

4

6

8

10

12

14

1 2 3 4 5 6 7

Co

ncen

trati

on

lo

g C

FU

/g

Clostridium

Lactobacillus

E.coli + Streptococcus

Bifidobacterium

Bacteroides

Strain choice: which species ?

birth infant weaning children adult senior


Strain selection: single strain or several ?

• Intestinal microflora contains 400-500 different bacterial species.

• These different bacteria reside in different niches of the intestinal tract (small intestine vs colon; luminal vs. mucosal).

• Single strains usually cannot reside in all these niches.

• Probiotic microbes effect host through multiple modes of action.

• A single strain is limited to a few modes of action.

Theoretically, a multiple strain product has many advantages over a single

strain product especially for a probiotic product aimed at well-being

(digestion & immunity) such as PROBACTI.

• However, some single strains have been shown effective in specific

applications: IBS, C. difficile infections, atopic eczema…


Strain selection: dosage

• Most of clinical studies conducted with probiotics and that have

shown positive results have been done with a dosage between

1 to 10 billion per day


Origin

• Vegetable

• Animal

• Human

Importance of this criteria ?

• Baby born with the gastrointestinal tract free of germ…

• Studies have shown that the ability to resist to acidity, bile, to

adhere to the intestinal cells does not depend on the origin*

* (Haller D.1 et al . Metabolic and Functional Properties of Lactic Acid Bacteria in the Gastro-

intestinal Ecosystem: A comparative in vitro Study between Bacteria of Intestinal and

Fermented Food Origin. Systematic and Applied Microbiology, 1 July 2001, vol. 24, no. 2, pp.

218-226(9)

?


Origin

• Lactobacillus acidophilus* Rosell-52

• Lactococcus lactis Rosell-1058

• Lactobacillus casei Rosell-215

• Bifidobacterium bifidum Rosell-71

Fermented dairy products

Healthy infants

* Reclassified as helveticus


Resistance to gastric acidity

• Stomach pH is very low (1 to 5), this is one of the body’s physiological

mechanisms to fight against foreign microorganisms.

• Majority of bacteria cannot survive in such an acidic environment

Probiotics must resist to stomach acidity



pH variations of stomach during the daytime

0

1

2

3

4

5

6

7

8 9 10 11 12 13 14 15 16 17

Day Time

pH

Breakfast

Lunch



53%

91% 91% 83%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Lactobacillus

Rosell 52

Lactobacillus

Rosell 215

Bifidobacterium

Rosell 71

Lactococcus

Rosell 1058

Survival of Probacti strains at pH4, after 120 min**Internal results


Resistance to bile salts

• Bile secretion is another body’s physiological mechanism to fight

against foreign microorganisms.

• The ability of lactic bacteria to develop in the presence of bile, even

with a slower kinetic growth, is one of the factors favorable to the

development of lactic bacteria in vivo in the large intestine.

Probiotics must resist to bile salts


Resistance to bile salts

•Even if the strains growth is inhibited in the presence of bile, the

strains are able to survive to bile salts

Probacti’s strains are able to survive bile salts

0%

20%

40%

60%

80%

100%

120%

Lactobacillus

Rosell 52

Lactobacillus

Rosell 215

Bifidobacterium

Rosell 71

Lactococcus

Rosell 1058

% grow th

% inhibition


Adhesion to intestinal epithelial cells

• Probiotics are not able to colonize the intestinal flora for a long

period of time, that is why they should be taken regularly

• Depending on their adhesion capacity to intestinal cells, they may stay

temporarily in the gut ( between 2 to 20 days)

• Unfortunately, it is very difficult to measure this adherence without doing

intestinal tissue biopsies. Therefore, scientists have developed in vitro

adherence tests with human cells grown in tissue cultures

Each PROBACTI strain has shown a good

adhesion capacity to intestinal cells


PROBACTI’s health benefits

• Restores the balance of the intestinal flora that is necessary for a good digestion by inhibiting the bacteria implicated in intestinal disorders

• May help to maintain the natural defenses


PROBACTI: Enhance the natural defenses*

*in vitro studies;

Ex: - B.Bifidum Rosell-71 decrease IL-8 and IL-10

Each PROBACTI strain has been tested for its

ability to stimulate some immunological

parameters (cytokines)


Lactobacillus acidophilus* Rosell 52:

Strengthen microflora balance

• L. acidophilus* Rosell-52 has been shown to

- prevent and eradicate intestinal dysbacteriosis (unbalanced microflora)

- maintain normal intestinal flora during antibiotic treatment

(Wasowska-Krolikoeska, K. et al, 1997)**

**Clinical study done with a blend of L. helveticus Rosell-52 and another probiotic bacteria

*Reclassified as helveticus

• Inhibition of Intestinal pathogens

Scale varies between 0 (no inhibition) and

90 (total inhibition).(Roques C. (2004) Laboratoire de microbiologie

industrielle et virologie, Faculté des sciences

pharmaceutiques de Toulouse. Evaluation de l’activité

antimicrobienne de souches probiotiques vis-à-vis de

pathogènes intestinaux. Unpublished results).


Lactobacillus acidophilus* Rosell 52:

Enhance the natural defenses**

• L. acidophilus* Rosell-52 : an activator of the immune response

- increases the number of immune cells ready to fight against infections

- stimulate innate immunity by activating macrophages able to recognized and

kill each « non self » cell

- stimulate acquired immunity by activating the production of antibodies that will

specifically recognized « invaders » and kill them

**in vitro studies* Reclassified as helveticus;


Bifidobacterium bifidum Rosell-71

• Inhibition of pathogens’ attachment

B. bifidum Rosell-71 may have beneficial

preventative effects against troubles caused by

E. coli O157:H7.(KOSTRZYNSKA et al, 2002).

• Immune modulation- B.bifidum Rosell-71 strongly upregulates proliferation of immune cells and

strongly downregulates IL-8 and IL-10 production*.

- Increases mucin expression in the jejunum and ileum.Godwin et al (2005) J. Ped. Gastroenterol. & Nutr. 41(4):558-559.

* In vitro tests


Lactococcus casei Rosell-215


Scale varies between 0 (no inhibition) and 90

(total inhibition).(Roques C. (2004) Laboratoire de microbiologie industrielle

et virologie, Faculté des sciences pharmaceutiques de

Toulouse. Evaluation de l’activité antimicrobienne de

souches probiotiques vis-à-vis de pathogènes intestinaux.

Unpublished results).

• Immune modulation*L. casei Rosell-215 strongly downregulates IL-8 and upregulates IL-6 production.

* In vitro tests


Lactococcus lactis Rosell-1058


Scale varies between 0 (no inhibition) and

90 (total inhibition).(Roques C. (2004) Laboratoire de microbiologie

industrielle et virologie, Faculté des sciences

pharmaceutiques de Toulouse. Evaluation de l’activité

antimicrobienne de souches probiotiques vis-à-vis de

pathogènes intestinaux. Unpublished results).


Fructooligosaccharide (FOS)

Only in sachets form

• Prebiotics:

“Non-digestible food ingredients (usually fibers) that beneficially affect the host

by selectively stimulating the growth and/or activity of one or a limited number

of bacteria in the colon, and thus improve host health.”

Contribution of FructoOligoSaccharides

-increase the number of Bifidobacteria, the Bifidogenic effect.

- increase the concentration of short chain fatty acids in the

intestine, such as butyric acid.

• Symbiotic are combinations of prebiotics and probiotic strains such that

the prebiotics support the effectiveness of the probiotics.


Product design

• Strain’s selection

Institut Rosell’s know how and proprietary technology for probiotic’s stability

• Stability

Institut Rosell has developed a proprietary technology to

ensure stability of its probiotics formulas

Careful treatment of strains from the laboratory scale to the

finish product

Treatment of raw materials and careful choice of other

functional ingredients and carriers


• Temperature

Environment

4 C is always the best for probiotics

until 25 C when formula is carefully designed

• Humidity


PROBACTI: features and benefits

A multi-strain probiotic product

Synergistic effect of probiotic strains which have each its

own probiotic effect

Sachet formula: the Symbiotic PROBACTI, +FOS for its

bifidogenic effect


PROBACTI: features and benefits

Selected and efficient strains

• Resistant to the gastrointestinal transit (acidity and bile)

• Able to adhere to intestinal cells

• Re-balance the intestinal microflora thanks to its inhibiting effect

against intestinal harmful bacteria

• Enhance body’s natural defenses

PROBACTI Probiotic’s shelf-life:

1 billion/capsule v#1, 24 months, 25 C

3 billions/capsules v#1 STAR, at manufacturing

5 billion/sachet, at manufacturing


PROBACTI: WORLDWIDE

RSA

(Nutrilida)

Italy

(Pegaso)

France

(Ponroy)

UK

Wren

Spain

(Intersa)

Poland

(Zlota)


AXIDOPHILUS: Italy

• PEGASO laboratory

•Bottles of 12, 30 and 60 caps

•Available in Pharmacies and herbal

stores

• Indication:

Dysbiosis

Balance of the intestine activity

Maintenance of the intestinal flora

Improvement of digestion

Lactose intolerance


ENTEROFLORE: France

• PONROY laboratory

•16 capsules in blisters or 180 caps in

bottle

• DTC: Web on line distribution

• Indication:

Restore the intestinal microflora balance

Improve the intestinal hygiene/health

To relieve intestinal dicomfort

To reinforce natural defenses

• Some testimonials:

Bring a real well being

Intestinal well being

Effective to avoid tourista


DTECTA: UK

• WREN laboratory

• Full range of probiotics

• 7 Sachets per box

• Pharmacies

• Indication:

Support digestive health

aid transit

promote a comfortably flat stomach


REGENELACTIS: Spain

•INTERSA laboratory

•20 sachets

•Pharmacies

• Indication:


Aid digestion

Stimulate defenses


PROBACTI 4: Poland

•ZLOTA

•Enteric capsules

•Pharmacies


PROBACTI 4: Poland


PROFLOR: South Africa

•NUTRILIDA laboratory

•Sachets and enteric capsules

•Pharmacies

• Indication:



CONCLUSION

PROBACTI IS A COMPLETE RANGE WITH SACHETS,

CAPSULES AND ENTERIC CAPSULES

PROBACTI IS WELL PRESENT IN EUROPE

PROBACT IS ESPECIALLY FORMULATED TO ENSURE

INTESTINAL WELL-BEING

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