A review on role of beneficial microorganisms and prebiotics in nutrition and healthcare and in supporting other therapeutics and future market of probiotics

8/13/2019 A review on role of beneficial microorganisms and prebiotics in nutrition and healthcare and in supporting other th

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UMAN PROBIOTICS AND PREBIOTICSINTRODUCTION

Probiotics are live microorganisms that are similar to the beneficial microorganismsfound in humans and are hence generally regarded as safe (GRAS). The concept ofprobiotics (which means !for life") was introduced in early #$th century by %lie&etschni'off.

Though they have been in eistence for many years the proper appreciation of theirbenefits is only a recent phenomenon. &ore and more research is being underta'ento validate their efficacy so far such activities have demonstrated their effectivenessin cases of antibiotic associated diarrhea irritable bowel syndrome lactoseintolerance oral health etc. The functional ingredients in the probiotic products helpin balancing the intestinal microbiota resulting in enhanced over all health well beingand boosts immune system.


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Human intestinal microbiota.

1, mouth; 2, pharyn; !, ton"ue; #, esopha"us; $, pancreas; %, stomach; &, li'er; (,trans'erse colon; ), "allbla**er; 1+, *escen*in" colon; 11, *uo*enum; 12, eunum; 1!,ascen*in" colon; 1#, si"moi* colon; 1$, ileum; 1%, rectum; 1&, anus.Ima"e a*apte* -rom .healthsystem.'ir"inia.e*u/u'ahealth/a*ult0*i"est/ima"es/ei0+1!2."i-.

The gut microbiota form a diverse and dynamic ecosystem including bacteriaArchaea and %u'arya that have adapted to live on the intestinal mucosal surface orwithin the gut lumen.

tomach an* *uo*enum

*arbor very low numbers of microorganisms+ , -$/ bacterial cells per gram

of contents &ainly lactobacilli and streptococci

Acid bile and pancreatic secretions suppress most ingested microbes

Phasic propulsive motor activity impedes stable coloni0ation of the lumen

eunum an* ileum

1umbers of bacteria progressively increase from approimately -$2cells in the 3e3unum to -$4 cells per gram of contents in the distalileum

3ar"e intestine

*eavily populated by anaerobes+ -$-# cells per gram of luminalcontents


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HITOR4The use of lactic acid bacteria as feed supplements goes bac' to pre56hristian timeswhen fermented mil's were consumed by humans. 7t was not until the beginning ofthis century that &etchni'off wor'ing at the Pasteur 7nstitute in Paris started to putthe sub3ect on to a scientific basis. *e believed that the flora in the lower gut was

having an adverse effect on the host and that these adverse effects could beameliorated by consuming soured mil'. 7n support of this he cited the observationthat 8ulgarian peasants consumed large 9uantities of soured mil' and also lived to agreat age he was in no doubt about the causal relationship and subse9uent eventshave in part confirmed his thesis.

*e isolated what he called the :8ulgarian bacillus: from soured mil' and used this insubse9uent trials. This organism was probably what became 'nown as ;actobacillusbulgaricus and is now called ;. delbruec'ii subsp bulgaricus which is one of theorganisms used to ferment mil' and produce yoghurt. After &etchni'off:s death in-SA. The American wor'ers showed that theyoghurt organisms could not colonise the gut and reasoned that if the effect was to

be manifested in the gut then a gut micro organism was more li'ely to produce there9uired effect. ?nowledge available at that time suggested the use of ;. acidophilusand many trials were carried out using this organism. %ncouraging results wereobtained especially in the relief of chronic constipation.

7n the late -


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5RO6IOTICThe microbial population of the digestive tract is largest in the caecum and proimalcolon with fewer numbers and species in the mouth stomach and small intestine.*owever these smaller populations can be important for health outcomes.

The relatively sparse flora of the healthy stomach is usually less than -$/

organismsper gram of contents comprising chiefly facultative anaerobes such as lactobacillistaphylococci and streptococci.

Rapid peristalsis and the bactericidal actions of gastric secretions limit colonisationof the upper small intestine to usually less than -$cellsBml of fluid. 8acterialnumbers especially of the strict anaerobes increase along the small intestineattaining a density of between -$=5 -$CBml in the distal ileum.7n adult humans the bacterial population is very large consisting of about -$ -2viablecells which account for about -$$ grams or $D of the wet mass of colonic contents(6ummings and &acfarlane -


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A probiotic contains thousands of genes which may potentially influence the clinicaleffects. @urthermore interaction with the host food components or endogenoussubstrates or the endogenous microbiota inside the gastrointestinal lumen maygenerate by5products or end5products with functional properties. There is a greathope that new (molecular combined with biostatistical) methods includingmetagenomics and metabolomics will help to dissect the compleicity. Thesemethods should for eample allow the discovery of novel genes and gene productswith novel properties which could be later used as drugs (eg small molecules orproteins with antimicrobial activities immunomodulating properties or interacting withintestinal functions).

The ma3ority of colonic bacteria are saccharolytic and several bacterial groupsincluding Eubacterium Bacteroides Bifidodobacteriumand Escherichia can fermentstarch (8rown et al.,-


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(KerdM %@ 8erci' P Kerma5Gandhu & et al. 3pecific probiotic therapy attenuatesantibiotic induced visceral hypersensitivity in mice. 4ut "##'$%%:12"&9#(

0 acidophilus16@& has also been reported to increase the visceral threshold in rats(as effectively as morphine) and to induce opioid or cannabinoid receptors on *T# including L. acidophilus and L.casei

bio'pluscom

#$r %ansen ?$e @nu!tris$ brand probioticculture range consists o Probio!?ec &o!5ast and ot$er nu!tris$culture blends it$ a ell!deined

viscosit proile t$at ermentuic'l

c$r!$ansencom

#erbios!P$arma Producer o Enterococcus 4AB S5*6

cerbiosc$

Danisco ?$e companCs cultures divisionproduces develops and mar'etsstarter cultures mediacoagulants and en:mes orc$eese res$ dair and ot$er oodproducts and also suppliesprobiotic cultures or oods andsupplements as ell as naturalood protectants

daniscocom

Danone Producer o several brands oermented dair productscontaining probiotics

danonecom

DS ?$e 4ati line o probiotics isormulated or stabilitsurvivabilit and concentrationand includes L. acidophilus (4ati410) L. casei (4ati 4"*) andBifidobacterium (4ati B.+)

dsmcom

-?# Nutrition Nutra5lora s$ort!c$ain ructo!oligosacc$arides (sc5S) are acane sugar or beet sugarEderivednatural prebiotic iber

gtcnutritioncom


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4allemand ?$is #anadian supplier deliversprobiotics and biosupplements tot$e nutraceuticals unctional!oods and p$armaceuticalsindustries

lallemandcom

National Starc$ ?$e %i!ai:e brand corn!based

resistant starc$ $as multiplebeneits including acting as aprebiotic or digestive $ealt$

$i!

mai:ecom

rati BeneoSnerg1 is t$e uniuepatented oligoructose!enric$edinulin prebiotic used in t$elandmar' Sn#an proFect onsnbiotics and colon cancer

oraticom

Probi ?$is biotec$ compan develops andpatents probiotic strains includingL. plantarum "..v and L.rhamnosus "71 L. plantarum "..$as not et been commerciali:edbut it is in t$e out!licensing p$ase

probicom

Proctor ,-amble

@Align is a probiotic supplementproduced b P,- Align capsulescontain Bifidobacterium infantis3*"+

aligngicom

Sanoi!Aventis Producer o Bacillus clausii strains/# N S2N and ? mar'eted inGurope Asia and Sout$ America asGnterogermina

sanoi!aventiscom

Sensus 5rutait inulin and 5rutalose ructo!oligosacc$arides (5S) are solubledietar ibers it$

biidogenic/prebiotic propertiessuitable or a variet o oodsstems to enric$ iber reducecalories and replace sugars andats

sensusus

Solva Producer o lactulose (Dup$alac)or treatment o constipation and$epatic encep$alopat$

solvacom

;alio ?$e Lactobacillus rhamnosus --probiotic is t$e most researc$ed int$e orld and as recentllicensed to Dannon or t$e 8Sogurt mar'et ?$e -eilus amilcontaining 4-- is mar'etedorldide

valioi

;S4P$armaceuticals

;S4H3 is a mi>ture o eig$t strainsit$ +0 billion live bacteria perpac'et

$ttp9//vsl3com

Iinclove ?$e compan sells mi>tures oprobiotic strains or dierentindications

inclovecom

:'i*ence>base* in*ications -or probiotics an* prebioticsin "astroenterolo"y


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Disorder action Product ecommended dose


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?reatment o acuteinectious diarr$ea inc$ildren

L. rhamnosus -- 1010E1011 cu ticedail

L. reuteri A??# 730 1010E1011 cu ticedail

L. acidophilus = B.infantis (2nloran strains)

10. cu eac$ t$reetimes dail

S. cerevisiae (boulardii)lo

"00 mg t$ree timesdail

?reatment o acuteinectious diarr$ea inadults

Enterococcus faecium4AB S5*6

106 cu t$ree timesdail

Prevention oantibiotic!associateddiarr$ea in c$ildren


"0 mg tice dail

L. rhamnosus -- 1010 cu once ortice dail

B. lactis Bb1" = S.thermophilus

107 = 10* cu/g oormula

Prevention o

antibiotic!associateddiarr$ea in adults

Enterococcus faecium

4AB S5*6

106 cu tice dail


1 g or 3 J 1010 cuper da


L. casei DN!11+ 001inermented mil' it$ L.bulgaricus = S.thermophilus

1010 cu tice dail

B. clausii(Gnterogermina strains)

" J 10. spores t$reetimes dail

L. acidophilus #41"6 =

L. casei 4bc60r

J 1010 cu once

dailPrevention onosocomial diarr$ea inc$ildren


B. lactis BB1" = S.thermophilus

106 = 107 cu/g oormula

B. lactis BB1" 10. cu tice dail

L. reuteri A??# 730 10. cu tice dail

Prevention o C.difficile diarr$ea inadults

L. casei DN!11+ 001 inermented mil' it$ L.bulgaricus = S.thermophilus

1010 cu tice dail

L. acidophilus = B.bifidum (#ultec$ strains) " J 1010 cu eac$once dail


" J 1010 cu per da

ligoructose + g t$ree times perda

AdFuvant t$erap orH. pylori eradication

L. rhamnosus -- * J 10. cu ticedail

B. clausii(Gnterogermina strains)

" J 10. spores t$reetimes dail

AB ogurt it$

unspeciied lactobacilliand biidobacteria

J 10. viable bac

tice dail


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1 g or J 10. cu perda

L. casei DN!11+ 001 inermented mil' it$ L.bulgaricus = S.thermophilus

1010 cu tice dail

educes smptomsassociated it$lactose maldigestion

egular ogurt it$ L.bulgaricus = S.thermophilus

&ogurt not $eat!treated aterpasteuri:ationcontains suitablecultures to improvedigestion o t$elactose in t$e ogurt

Alleviates somesmptoms o irritableboel sndrome

B. infantis 3*"+ 106 cu once dail

L. rhamnosus -- * J 10. cu ticedail

;S4H 3 mi>ture + J 1011 cu ticedail

L. rhamnosus -- L. rhamnosus 4#70 B. breveBb.. and Propionibacterium freudenreichii sspshermanii

1010 cu once dail

B. animalis DN!173 010 in ermented mil' it$ L.bulgaricus = S. thermophilus

1010 cu tice dail

aintenance oremission o ulcerativecolitis

E. coli Nissle 1.17 J 1010 viable bactice dail

Prevention andmaintenance o

remission in pouc$itis

;S4H 3 mi>ture o 6strains (1 S.

thermophilus +Lactobacillus 3Bifidobacterium)

+ J 1011 cu ticedail

?reatment oconstipation

4actulose "0E+0 g per da

ligoructose K "0 g per da

Prevention onecroti:ingenterocolitis inpreterm inants

B. infantis S.thermophilus and B.bifidum

03 J 10. cu eac$strain once dail

L. acidophilus = B.infantis (2nloran strains)

10. cu eac$ ticedail

Prevention opostoperativeinections

Snbiotic "0009 +bacteria strains andibers including t$eprebiotic inulin

1010 cu = 10 gibers tice dail

?reatment o $epaticencep$alopat$

4actulose +E.0 g per da


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5R:6IOTIC

A prebioticis a selectively fermented ingredient that results in specific changes in

the composition andBor activity of the gastrointestinal microbiota thus conferringbenefit(s) upon host health. (Gibson et al. #$-$. @ood Science and Technology8ulletin+ @unctional @oods 4 (-) -I-nli'e probiotics most prebiotics are used as food ingredientsin biscuits cerealschocolate spreads and dairy products for eample. 6ommonly 'nown prebioticsare+- ligofructose# 7nulin/ Galacto5oligosaccharides2 ;actulose 8reast mil' oligosaccharides

There is a growing list of candidate prebiotics such as polydetrose soybeanoligosaccharides isomaltooligosaccharides gluco5oligosaccharides ylo5oligosaccharides. palatinose gentio5oligosaccharides and sugar alcohols (such aslactitol sorbitol and maltitol). *owever the evidence for these especially in humansis not as well advanced as it is for @S and GS.=%ffects of PrebioticsO &etabolic effects+ production of short5chain fatty acids fat metabolism absorptionof ions (6a @e &g)O %nhancing host immunity (7gA production cyto'ine modulation etc.)


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5RCIIC 5RODUCT 67:D ON TH: :ND U7=:?unctional -oo*s an* be'era"es > *airy pro*ucts, non Dairy be'era"es,brea@-ast cereal, ba@e* "oo*s, -ermente* meat pro*ucts, *ry>-oo* probiotics;animal -ee* probiotics; *ietary supplements > -oo* supplements, nutritional

supplements an* specialty nutrient.

election o- microbes -or probiotic>base* strate"ies.


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7pplications?Human application > re"ular consumption, probiotic therapy, pre'ention o-*iseases an* probiotic application -or animals.

Probiotic bacteria have a variety of uses in the present society. Primarily they areused as a preventative measure against a variety of infections. 7n the studyperformed by @ric' et al the scientists tested whether strains modulatinginflammatory reponses in vivo could prevent ESS induced acute colitis. ?ey resultswere that they found that the probiotic bacteria increased the resistance of mice tothe infection. They also saw that the probiotic bacteria inhibited inflammatoryprocesses in vivo. The mouse model of oral Qersiniosis showed that theadministration of viable B. adolescentis (the probiotic bacteria in 9uestion) protectedmice from the generali0ation of . enterocolitica infection. 7n fact in mice models withthe detran sodium sulfate5induced5 colitis B. adolescentis attenuated thedevelopment of colitis indicating anti5inflammatory properties.

(@ric' et al.)

ther uses for probiotics involve the commensal bacteria to be used as a neonatalnutrition source. @or eample research has shown that probiotic bacteria aretransferred through breast mil' from mother to infant (livares et al.) As mentionedpreviously having proper intestinal flora is very important to gastrointestinal health.Thus for infants that are not breast5fed proper supplements must be given with thebacteria added to it to ensure gut health.


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9:CH7NI9 O 7CTION 64 5R:6IOTIC 7ND 5RO6IOTICThe intestinal microflora li'ely plays a critical role in inflammatory conditions inthe gut and potentially probiotics could remediate such conditions through

modulation of the microflora.

Eifferent strains of ;actobacillus have shown to have varying degrees of adherence.Researchers tested the adhesive capacity of selected enterococci to human canineand porcine intestinal music was investigated in order to select for potential probioticstrains with good adhesive properties for human or animal use. The 'ey results werethat a strong correlation was observed for the adhesion to human and canineintestinal mucus and also between porcine and canine or human mucus. Two surfaceproteins have been identified that are associated with association and may beinvolved in adhesion of enteroccoci+ the aggregation substance and enterococcalsurface proteins (;au'ova et al.) Thus adhesion of these probiotics bloc's otherpathogenic bacteria.

Hhile it has been established that adherence is 'ey to ;actobacillus resistance ofvarious gastrointestinal pathogens studies have been done to eamine whereeactly the lactobacillus adheres to to provide said resistance. The 'ey results werethat there were four sites of recovery for the probiotic bacteria+ the cecum thetransverse the descending colon the sigmoid colon (&orelli et al.).

Hhile competition is a strong mechanism of resistance it is not the only one used byprobiotics.%vidence has been given to show that probiotic bacteria ;actobacilli eertbacteriostatic or bactericidal effects against bacterial pathogens namelyelicobacter pylori

(6ruchet et al.)


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@urther research with this pathogenBprobiotic shows that 0actobacillus not only 'ills itbut also prevents 7;5C release (*amilton5&iller et al.) The authors speculate that themechanism by which 0actobacillus bloc's elicobacter pylori is combination of thefollowing+ competition for nutrients competition for eclusion production of inhibitorycompounds and immunomodulatory stimuli (*amilton5&iller et al.).Another species of bacteria that is affected by probiotics is N. onorrhoeae. Studiesshow that when probiotics are given to individuals who are infected with N.onorrhoeae, symptoms are alleviated. The mechanism by which this is achieved isagain when the 0actobacillus administered binds to the cells and thereforepreventing the adhesion of the pathogenic bacteria.(http+BBwww.wpi.eduBPubsB%5pro3ectBAvailableB%5pro3ect5$/-C$


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well as


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Probiotic bacteria containing 5galactosidase can be added to food to improvelactosemaldigestion(?im and Gilliland -


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5ROO O 7CTIAIT4

Scientists have come up with techni9ues to follow and trac' the progress of theprobiotic bacteria through the gastrointestinal tract. 7n a study mentioned previouslya tests were performed in vivo and the scientists stained the bacteria with c@EA5S%and under observation reali0ed that the bacteria was locali0ed in the rectum andalso in the 3e3unum and ileum. This is important since they 'now that the probioticbacteria can locali0e and adhere to the G7 tract and thus provide competition to thepathogenic bacteria(8ou0aine et al.)

Another method of trac'ing the progress of the probiotic through the G7 tract isthrough G@P staining. Scientists reali0ed that bacteria can be difficult to follow

through the gastrointestinal tract so they decided to label it with a plasmid containingG@P. They used rats for the in5vivo models and then too' samples from thestomach 3e3unum ileum caecum colon and rectum to test for presence of %c1.They found that the %c15G@P was detectable in high numbers in the stomach and inlower numbers in the caecum but not in the rectum at the beginning of theeperiment. They also found out that the organisms were locali0ed close to theepithelial surface of the stomach cecum and rectum and also in the lumen of theintestine. The transformation of %c1 to obtain %c15G@P in this study had nodetectable influence on the probiotic microorganism regarding adhesion on andinduction of 7;5C secretion of *T5#< cells and allowed the detection in miedmicrobial environments(Schult0 et al.)


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7:T4Probiotics as treatment are still a novel concept in the medical world and leads to

9uestions and doubts in the minds of many. *owever one can rest assured thatstudies are heavily underway to test for the safety and reliability of probiotics.Research has been done to determine any toicity present through the usage ofprobiotic bacteria 8acillus (subtilis and indicus). Researchers tested guinea pigs andrabbits since they are considered the most sensitive lab animals. 1o noticeabledifferences could be seen in the animals tested thus they can assume that theprobiotic bacteria are harmless(*ong et al.).


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97RB:T URA:48eneficial microorganisms can be used in food feed drin'ing water over pond watermediums in the environment.

8eneficial microorganisms can be used in controlling

8acterial fungal and viral infections

6ancer

6holesterol

%ternal parasites

7nsects

7nternal parasites besity

Pests

8eneficial microorganisms can be used as alternate antibiotics pesticidesinsecticides growth promoters.

8eneficial microorganisms can be used as

Anifungals

Antibiotic s

Antivirals

%n0yme producers


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@6R 7mprovers

Growth promoters

Gut acidifiers

7mmuno modulators

7nsecticides &eat tenderi0ers

ygen liberators

Parasiticides

Pesticides

Pollutant degraders

Proto0oacides

Toin binders

Uoothamnicides

Role o- 5robiotics To combat diseases li'e as 7rritable 8owel Syndrome (78S) dyspepsia

chronic diarrhea or constipation. To curdle mil'

To detoify

To eliminate pathogens

To eist symbiotically

To fight against certain cancers.

To help in ;actic intolerance

To help in producing short chain fatty acids (S6@As)

To help liver and 'idneys in discharging their functions

To help regulate the immune response

To improve mineral absorption

To improve Total digestible 1utrients (TE1) of the food inta'e.

To inhibit ;E; accumulation

To maintain optimum micro flora

To reduce Triglycerides

To reduce the stress owing to high levels of Antibiotics

7cti'ities o- 5robiotic 6acteria

Anti colon cancer effects

Anti &il' allergy Anti5diarrheal effects

6holesterol lowering

6orrection of *ypertension

7mmune system modulation

7mproved tolerance to mil'

7ntestinal health maintenance

Reduction of ;actose intolerance

Suppression of harmful intestinal microbe activities

Suppression of pathogen translocation

KaginalBurinary tract health maintenance

7CTOR TH7T 97B: U7=: O 5RO6IOTIC


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7 TH: ON34 6:T 73T:RN7TIA: Abuse of Antibiotics

Abuse of Growth promoting antibiotics and chemicals

Abuse of *ormones

Abuse of Pesticides insecticides

Abuse of dewormers parasiticides disinfectants saniti0ers etc

Probiotics belonging to the functional group of gut flora stabilisers within thecategory of 0ootechnical feed additives (according to the Regulation %6 1o-C/-B#$$/) is a fast growing mar'et

The probiotics mar'et has been one of the prime beneficiariesof the recent fad over functional foods. Rising levels of healthconsciousness and the ageing baby boomer population are a few of the drivershelping in the growth of the mar'et. The other ma3or mar'et factor drivingthe overall probiotics mar'et in the present and epected to continue to do

so in the future is the influence eerted by the women buyer segment. 7t isgenerally observed throughout the globe that traditionally women areresponsible for the buying decisions of the foods and beverages (@V8)category in families. Since they tend to be more aware about the new productsand their health benefits they try and incorporate more beneficial foods inthe families: diet. *ence it is no surprise that women have more 'nowledgeabout probiotic @V8 and conse9uently not only drive their consumption butalso act as the opinion ma'ers. This gathers more importance considering thefact that the probiotic @oods V 8everages segment is epected to command over4D of the overall probiotics mar'et in #$$.S. the mar'et is epected to grow at an astounding rate of almost -2D inthe same period driven by the large scale acceptance of 5 the probioticyogurts in spoonable single serve pac's probiotic cultured drin's in singleshot pac'aging form and probiotic dietary supplements.

Products that fall under the niche category presently such asprobiotic chocolates probiotic ice creams and probiotic ba'ed products areepected to en3oy a much larger mar'et share due to the belief that consumersare ready to pay an etra amount for fortified products if confident of:etra: benefits. *owever probiotic cheese probiotic butter etc are fatedto the status of ultra5niche products due to their conventional image asunhealthy dietary products.

The global mar'et estimate of functional foods has been up to 4/ 8illion and anannular growth rate of C5-=D.7n a recent study underta'en by;eatherhead @ood RAthe mar'et for functional foods in the >nited ?ingdom @rance Germany Spain8elgium 1etherlandsEenmar' @inland and Sweden was reviewed. The results ofthestudy showed that the probiotic yogurt mar'et in these < countries totalled X#$million 'g in -


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million 'g valued at>SW#-< million. The German mar'et for probiotic yogurts isgrowingrapidly for eample during -


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7ndia is also fast emerging as a potential mar'et for probiotics in food. Probioticproduct industry in 7ndia was estimated to be around Rs #$.= million with a pro3ectedannual growth rate of ##.=D until #$-.

T7TUTOR4 R:=U37TION?ne ma3or attribute of probiotics is the lac' of adverse events associated with theiruse.(Gregor Reid Canadian esearch and *evelopment Centre for 1%

7nternational guidelines on probiotics in food broadly specify the 'ind of tests thatmay be re9uired to determine the safety and to assess the health claim of a probioticproduct in food. Such tests are based on the current understanding of the sub3ect.The regulatory mechanism for probiotics differs from country to country and alsoeven within a country.

7n 7ndia there are no regulatory guidelines for probiotic foods upto #$--.

*owever a Tas' @orce was constituted by 76&R in #$-- and theguidelines proclaimed by it are given below.

#. G>7E%;71%S A1E R%Z>7R%&%1TS @R PR87T76 PRE>6TS


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#.4./ 7f the strain under evaluation belongs to a species that is a 'nown mammaliantoin producer or of hemolytic potential it must be tested for toin production andhemolytic activity respectively.Assessment of lac' of infectivity by a probiotics strain in immunocompromisedindividuals would be an added measure.

2.( :'aluation o- e--icacy stu*ies in humans? The principal outcome of efficacystudies on probiotics should be proven with similar benefits in human trials such asstatistically and clinically significant improvement in condition symptoms signs well5being or 9uality of life reduced ris' of disease or longer time to net occurrence orfaster recovery from illness. %ach of the parameter should have proven correlationwith the probiotics tested.Probiotics delivered in food may not be tested in Phase / studies (effectiveness)unless the product ma'es a specific health claim wherein it becomes imperative togenerate the re9uired evidence necessitating carrying out Phase / studies.

7f a probiotic food has a record of documented long and safe use outside the country

the data regarding this could be reviewed and deemed as sufficient to allow itsmar'eting within thecountry. *owever labeling of health benefits may re9uire evaluation in a differentmanner.Hhile ta'ing into account studies done abroad efficacy studies of probiotics (whichare of proven benefit in [other populations) should also be conducted on 7ndiansub3ects. 7t is recommended that such [bridging human trials should comply with theprinciples laid down by the Erug Regulatory Authority. Adverse effects if any shouldbe monitored and incidents reported to the appropriate authority.

2.) :--ecti'e *osa"e o- probiotic strain / strains? The minimal effective dose orthe level of viable cells of the probiotic strain in terms of cfuBmlBday in the carrier food

that demonstrates general health promoting functions or well being or specific healthclaims in target population should be clearly indicated.

2.1+ 3abelin" Reuirements? 7n addition to the general labeling re9uirements underthe food laws the following information should also be mentioned on the label(#//


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creenin" o- 5otential 5robiotic trainsG In vitroTestsF

In vivo stu*ies in 'ali*ate* animal mo*els -or?Ga-ety

G:--icacyFIn vivo stu*ies in humans -or clinical e'aluationsG 5hase1 sa-etyG 5hase 2 e--icacyG 5hase ! e--ecti'enessF

5RO6IOTIC OODF3abelin" ReuirementsG =enus, pecies, trainG9inimum 'iable numbers o- probiotics at the le'el at hich e--icacy is claime* an* at

the en* o- shel-> li-e.G Health claimsG er'in" siEe -or e--icacyG tora"e con*itions Only reuire* i- a speci-ic health claim is ma*e

R::R:NC:?8ou0aine T. RE Eauphin Ph. Thonart &6 >rdaci and &. *amdi. >dherence andcoloni5ation properties of ;actobacillus rhamnosus 8B1, a broiler chic)en isolate. ;etters inApplied &icrobiology #$$. #+? p. /


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?ruger 6arina Qan0hong *u Ziang Pan *arold &arcotte. ;n situ delivery of passiveimmunity by lactobacilli producin sinle-chain antibodies. 1ature 8iotechnology #$$#. 2+? p.4$#54$=.

;au'ova A. K. Strompfova and A. uwehand.>dhesion dhesion of ;actobacillus plantarum "+ and;actobacillus salivarius "1 to the intestinal tract of pilets, as recorded ith fluorescent insitu hybridi5ation ;3(, and production of plantaricin "+ by cells coloni5ed to the ileum.Lournal of Applied &icrobiology #$$=. 1++? p. C/C5C2.

&ishra Ki3endra. E.1. Prasad.>pplication of in vitro methods for selection of ;actobacilluscasei strains as potential probiotics. 7nternationa Lournal of @ood &icrobiology#$$. 1+!? p.

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Documents

A review on role of beneficial microorganisms and prebiotics in nutrition and healthcare and in supporting other therapeutics and future market of probiotics