PROBIOTICS - A REVIEW

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About Authors:
V.Sankar¹*, Akash kurian²
*¹Department of Pharmacy Practice, PSG College of Pharmacy, Coimbatore.
²PHARM.D Intern, PSG College of Pharmcy, Coimbatore.
*akash.kurian8@gmail.com

Abstract:
The objective of review is to outline the probiotics use in medicine and to give insight in to the field for different applications. The use of probiotics in treatment regimen is increasing. Probiotics are live organisms and prebiotics are components of food that are not otherwise easily digested by humans and these food components essentially feed beneficial bacteria in the gut. Probiotics can be formulated to many different types of products including drugs, foods and dietary supplements. Species of lactobacillus and bifidobacterium are most commonly used as probiotics. Probiotics are intended to assist the body’s naturally occurring gut mitochondria. Some probiotic preparations have been used to prevent diarrhea caused by antibiotics or as part of treatment for antibiotic related dysbiosis. This article focus on the probiotics use,  clinical trials and its future.

REFERENCE ID: PHARMATUTOR-ART-2132

History:
A century ago, Elie metchnikoff postulated that lactic acid bacteria (LAB) offered health benefits capable of promoting longevity^[1]. He suggested that intestinal auto intoxication and resultant aging could be suppressed by modifying the gut microbiota and replacing proteolytic microbes such as clostridium which produces toxic substances including phenols, indoles and ammonia from digestion of proteins with useful microbes. In 1917 the German professor Alfred nissle isolated a non pathogenic strain of Escherichia coli from feces of First World War soldier who didn’t develop enterocolitis during severe outbreak of shigellosis^[2].

Bifidobacterium was isolated by Henry Tissier from a breast fed infant, and he named the bacterium Bacillus Bifidus communis. He claimed that Bifidobacteria would displace the proteolytic bacteria that cause diarrhea and recommended administration of bifidobacteria to infants suffering from this symptom^[3]. The term robotics was introduced in 1965 by Lilly and Stillwell^[4]. In 1989, Roy fuller emphasized the requirement of viability for Probotics and introduced the idea that they have beneficial effect on host^[5].

Dose:
The doses needed for probotics varies greatly depending on strain and product. Although many OTC products deliver in range of 1-10 billion cfu/dose, some products shows efficous at low level, while some require more. Dose that is needed for probiotics, should be passed on human studies showing health benefits.

The minimum criteria that have to meet for probiotic products are probiotics must be:

• Specified by genus and strain.
• Alive.
• Deliver adequate dose through end of shelf life.

Immunologic benefits:

1. Activate local macrophages to increase antigen presentation to beta lymphocytes and increase secretory immunoglobin A (IgA) production both locally and systemically.
2. Modulate cytokine profiles.
3. Induce hypo responsiveness to food antigens.

Non-immunologic benefits:
a. Digest food and compete for nutrients with pathogens.
b. Modify pathogen derived toxins.
c. Stimulate epithelial mucin production.
d. Alter pH to create an unfavorable local environment for pathogen.

COMPLICATIONS

MAJOR
The safety of probiotic ingestion has been evaluated by examining infectivity, metabolic activity, pharamacokinetics, pathogenicity and virulence factors associated with toxicity in healthy people. Reports of harmful effects of probiotics ingestion are rare and overall probiotics are considered safe and well tolerated.

The potential for bacterial translocation, resulting in bacteremia is a concern in patients who are immunocompromised secondary to premature birth, malignancy, HIV virus infection or a chronic debilitated state. Bacterial translocation may develop when G.I tract barrier is diminished allowing bacteria to pass across mucous membrane and epithelium and be transported to mesenteric lymph nodes and others.

(b) MINOR:
Fungemia, G.I inflammation.

Products–
Most common forms for probiotic are dairy products and probiotic –fortified foods. However tablets, capsules and sachets containing the bacteria in freeze dried form are available in Table n.o 1.

Information on suppliers of probiotics^[6]:

Table n.o 1

a ) Product Selection
Probiotics are sensitive to environmental conditions including pH, moisture, temperature, air and light. As soon as probiotic is manufactured the number of viable colony-forming units begins to decrease as a part of the natural life cycle of organism. For effective probiotic dose it should survive in G.I tract colonize and replicate.

The number of viable bacteria reaching and colonizing the G.I tract depends on several factors including dose, formulation, G.I motility, patient’s gastric acid pH and co administration of food or milk (which may aid in probiotic viability). A probiotic should contain at least 10⁸ CFU. This dose will increase the likelihood that a sufficient amount will survive and colonize G.I tract. Probiotic products available in Indian market and its clinical applications are given in Table n.o 2 and Table n.o 3.

Products available in Indian market ⁷

Table n.o  2

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Clinical applications⁸:

Table n.o 3

ROLE OF THE PHARMACIST:
The pharmacist’s role in appropriate probiotic product selection and patient education is important for positive therapeutic outcomes with multiple probiotic formulations on the market, internet distributors and misleading or confusing claims in the media. Pharmacist should educate patients about the appropriate use, selection, storage, and administration of probiotics. Reports of clinical trial of probiotics are cited in Table 4.

Probiotic clinical trial reports :

Table n.o  4

Future:
The new generation biotech drugs and dietary supplements developed from yeast or lactic acid bacteria (LAB), is emerging as a major opportunity in the domestic and international markets for research driven Indian drug companies. At least 39 probiotic drug brands, mainly in the area of gastroenterology, from 30 major Indian companies have already created a probiotics drug market in India worth Rs 80 crore, with a year-on-year growth of 41.1 per cent. The market was likely to grow further in the coming years as many of the major Indian pharmaceutical companies are in the process of developing and in-licensing probiotic drugs.
Darolac and Sporlac, two gastro-related drugs in this category from Aristo Pharmaceuticals and Uni-Sankyo respectively, enjoy a market share of Rs 7.9 crore each. Tablets India’s Bifilac, prescribed for antibiotics induced diarrhea, is the largest brand currently in India with annual sales of Rs 9.9 crore. US Vitamin's ViBact is another major brand in this category with a turnover of Rs 8.2 crore, according to the data from ORG-IMS^[14]. Probiotic related functional foods are gaining popularity in India.  Amul recently launched an innovative probiotic ice-cream with health claims. Alkem Health Foods has launched health supplements, sweeteners, ready to eat cookies and jellies. Some of strains which are under research are given in Table n.o 5 which may be the future of probiotics.

Table n.o 5

Tested as mixture:

Conclusion:
Pharmacists can play an integral role in the optimal use of probiotics by recommending the appropriate probiotic product to health care providers and patients and through reviewing the current literature, delivering patient patient education, dispensing high quality products and monitoring patient outcomes. High-profile probiotic containing products have been hugely successful in Europe, asia, and in other regions of the world. The marketing success will promote consumption, product development and research in probiotics.

References:
1. Lisa S Smith, Joy B Greene. Probiotics in Gastrointestinal Disease. In: Katherine Hammond Chessman.washington : American college of clinical pharmacy;2009.83-89.
2. Trevor young.shigellosis.2010March.
3. World Gastroenterology Organisation Global Guidelines.2008May.
4. Probiotics And Definitions: A Short Overview Volker Rusch.
5. Roy Fuller.Probiotics :Their Development and use.
6. World Gastroenterology Organisation Global Guidelines.2011October.
7. cimsasia.com
8. Lisa S Smith, Joy B Greene. Probiotics in Gastrointestinal Disease. In: Katherine Hammond Chessman. washington: American college of clinical pharmacy;2009.83-89.
9. Probiotic In Preterm Babies study. 2013 july
10. Ravi Prakash,Kevin.D.Mullen.Mechanisms,Diagnosis and Management of Hepatic Encephalopathy 2010 august 10.
11. Lesley M Roberts, Deborah MCcalon ETal.A Randomised Controlled Trial of a Probiotic ‘functional food’ in the management of irritable bowel syndrome. 2013 March
12. Lee J,Seto D etal Meta-analysis of clinical trials of probiotics for prevention and treatment of pediatric atopic dermatitis. 2008 January.
13. drahoslava lesbros-pantoflikova, Irene corthesy-theulay etal. helicobacter pylori and probiotics.2007 March.
14. consumerlab.com

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