March 23, 2019, 2:55 pm
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Probiotics
Category: Probiotics & Prebiotic

Probiotics were defined in 2001 by a group convened by FAO/WHO Expert Consultation as live microorganisms, which when administered in adequate amounts confer a health benefit on the host.  The concept behind probiotics was introduced in the early 20th century, when Nobel laureate Elie Metchnikoff, known as the “father of probiotics,” proposed in The Prolongation of Life: Optimistic Studies that ingesting microorganisms could have substantial health benefits for humans. Scientists continued to investigate the concept, and the term “probiotics”—meaning “for life”—eventually came into use.

Probiotics have been proposed for use in inflammatory, infectious, neoplastic, and allergic disorders, the ideal probiotic strain for many of these indications has yet to be defined, although progress continues in this area. &nb

 
 
Probiotics and Pediatrics
Category: Probiotics & Prebiotic
The American Academy of Pediatrics (AAP) reviewed the currently known health benefits of Probiotics and Prebiotics, including those added to commercially available infant formula and other food products available for use in children

The addition of probiotics to powdered infant formula has not been proven harmful to healthy term infant’s .However, there is no evidence of clinical effectiveness, and the routine use of these formulas is not recommended. No studies have compared the health benefits of using these formulas versus breastfeeding. Probiotics should not be given to children who are seriously or chronically ill until safety of these products has been established. The optimum duration of probiotic supplementation is not known nor is the original dosage or species .The long-term effects on microflora in children are also not known. On the other hand and since Human milk contains substantial quantities of prebiotics and is preferred for infants up to six months of age, the addition of oligosaccharides as prebiotics to infant formula is not unreasonable but lacks evidence showing clinical effectiveness .It is not known whether their use is cost-effective.

Probiotics use has been shown to be modestly effective in randomized clinical trials (RCTs) in (1) treating acute viral gastroenteritis in healthy children as it may reduce its duration by one day. This benefit is strain-dependent. However, the evidence does not support the routine use of probiotics to prevent infectious diarrhea unless there are special circumstances; and (2) preventing antibiotic- associated diarrhea in healthy children. However, there are not RCTs examining the effects of probiotic use in children with Clostridium difficile antibiotic –associated diarrhea.

There is some evidence that probiotics prevent necrotizing enterocolitis in very low birth weight infants (birth weight between 1000 and 1500 g). However, the amount and specific type of probiotics are difficult to determine and more studies are needed. There is also some evidence supporting prophylactic maternal use of probiotics during pregnancy and the continuation of therapy in the mother and infant during lactation in preventing childhood atopy but further studies are needed. Probiotic use has not been effective in the treatment of eczema.

The results of RCTs in which probiotics were used to treat childhood Helicobacter pylori gastritis, irritable bowel syndrome, chronic ulcerative colitis and infantile colic, although encouraging, are preliminary and require further confirmation.

In a randomized, double-blind trial reported in the june 2011 issue of Pediatrics, fermented milk containing probiotics was found no better than a control dairy product for treating constipation in children; Children were given nonfermented dairy product twice daily for three week or a control milk-based .The children were 7 years old on average .They had had constipation for a mean duration of 3.4 years. Future studies should focus on whether a longer period of probiotic products is more effective in children who have a short history of constipation.

 
 
Probiotics and Adults
Category: Probiotics & Prebiotic

The evidence for the impact of probiotics on diverse end points of human health is mounting, driving the commercial development of products containing them.

It is important to recognize that the immunomodulatory activity of probiotic bacteria is unique to a particular strain. Thus, not all species will necessarily have the same therapeutic potential in a particular condition.

Probiotics are identified by genus, such as Lactobacillus or Bifidobacterium, and then by species of each genus. Different strains of the same species can have different characteristics, strengths and weaknesses. It is important to recognize that the clinical support to substantiate claims must be specifically based on each probiotic strain\ or blend of strains that are used. It should be noted that some probiotic combinations have been shown to prove antagonistic, rather than synergistic, in certain situations.

Understanding of how these products work and interact with our immune systems and gut linings is still in its infancy.

Studies indicate that probiotics may have a role in treating gastrointestinal illnesses, boosting immunity, and preventing or slowing the development of certain types of cancer.

In two recent National Center of Complementary and Alternative Medecine (NCCAM) - funded studies, researchers investigated how probiotics may promote such health benefits. Researchers at Baylor College of Medicine and M.D. Anderson Cancer Center investigated how Lactobacillus reuteri ATCC PTA 6475 might work to slow the growth of certain cancerous tumors. Their study documented the molecular mechanisms of the probiotic’s effects in human myeloid leukemia-derived cells—the researchers noted that a better understanding of these effects may lead to development of probiotic-based regimens for preventing colorectal cancer and inflammatory bowel disease.

 Other studies have examined the effectiveness of daily treatment with probiotics to prevent antibiotic-associated diarrhea (AAD), but results have been mixed.

Based on data from a meta-analysis of more than 3000 patients, 63% of which were adults, prophylactic use of probiotics appeared to reduce the odds of developing AAD by 60%. The probiotic treatment periods ranged from 5 days to 3 weeks with average treatment duration of 1.5 weeks.The findings were presented at the annual meeting of the American College of Gastroenterology. This analysis clearly demonstrates that probiotics offer protective benefit in the prevention of AAD. However, additional prospective studies are needed to determine the most effective dose, duration and specific species of probiotics to prevent AAD in these patients.

Another double-blind, randomized, placebo-controlled, parallel-group intervention study was conducted in patients with active Clostridium difficile disease (CDD).

A total 124 Patients received standard antibiotics and oral Saccharomyces boulardii (1g/d for 4 weeks) or placebo for 4 weeks and were followed up for an additional 4 weeks after therapy.  The efficacy of S boulardii was significant (recurrence rate 34.6% compared with 64.7% on placebo). Results showed that the combination of standard antibiotics and S boulardii is a more effective and safe therapy for patients with recurrent CDD but no benefit was demonstrated for those with an initial episode of CDD.

In a 2007 randomized, placebo-controlled trial of 135 hospitalized patients on antibiotics, patients who receive Actimel, a yogurt-type drink containing the patented yogurt culture know as Lactobacillus casei Immunitas, were significantly less likely to develop Hospital –aquired diarrhea, compared with those who received placebo (12% vs. 34% respectively) .A similar association was seen in the prevention of hospital-acquired C. difficile (BMJ 2007; 335-80).

Another randomized , multicenter placebo-controlled trial of 362 patients with Irritable bowel syndrome (IBS),  encapsulated B.infantis were administered at the dose of 1x10(8) CFU for 4 weeks, showed that an  improvement in  global symptom assessment that exceeded placebo by more than 20% ( p<0.02).

However, the lack of clinical benefit observed with other dosage levels highlight the need for clinical data in the final dosage form and dose of probiotic before these products should be used in practice.

Another product, Activia, a yogurt containing Bifidus regularis and Bifidobacterium animus, has been shown in scientific studies to increase transit time in women and older adults but it would not be classified as medical food.

In Ulcerative Colitis there is marginal but significant evidence of efficacy of some strains in inducing or maintaining remission in adults. There is strong evidence of efficacy in pouchitis especially with the use of VSL#3 in adults, and there is an emerging possibility of promising efficacy in children.

Other potential future applications include use in reducing cholesterol levels, treating obesity, Crohn’s disease and managing irritable bowel syndrome.

 
 
Probiotic and Elderly patients
Category: Probiotics & Prebiotic

One of the major problems that the elderly face is a dysregulation of the immune response, which predisposes them to infectious diseases as well as to cancer. In fact, few studies have evaluated the effect of probiotics on the immune response of the elderly, but those conducted thus far suggest that they could be beneficial. Longer-term randomized, double-blind, placebo-controlled human trials with adequate numbers of elderly subjects and clinically relevant outcomes as well as studies in animal models will help to confirm these data.

 

 
 
Probiotic regulation: Food or Drugs?
Category: Probiotics & Prebiotic

Despite the fact that probiotics are advocated for the management of disease, they are regulated, in most jurisdictions, in a manner that is more akin to a food than a pharmaceutical. This situation may change very soon, as agencies in both the United States and in Europe are currently re-evaluating the status of these products.

In the United States, foods and dietary supplements are allowed to make what are called structure or function health benefit claims, which relate the product to a physiologic effect on the normal (not diseased) structure or function of the human body . In the FDA, probiotics fall under Dietary Supplement Health and Education Act (DSHEA) as the regulatory category. Claims on products under DSHEA are required to be truthful and not misleading. Therefore, companies making such claims are required to have substantiating scientific documentation. However, the claims are not subjected to premarket regulatory approval. In practice, the FDA does not police the accuracy or degree of substantiation for such claims; therefore, it is likely that some number of commercial products assert unsubstantiated communications on labels, Web sites, or advertising. With regard to content claims, numerous published articles report independent analysis documenting probiotic products that do not have either the number or the type of microbes claimed on the label. Although Good Manufacturing Practices exist for both foods and dietary supplements, products still may not be accurately labeled.

Accordingly, it is difficult for the consumer and the health care professional to distinguish the substantiated from the unsubstantiated claim.

Deliberations by the European Food Safety Authority on health claims for probiotics pursuant to European Union Regulation 1924/2006 will undoubtedly set a much higher standard for all health claims relating to nutritional products, including probiotics.

In Europe, the European probiotic food industry may be frozen out of the consumer market as a result of new European Union nutrition and health regulations (EFSA) submitted in 2007 requiring industry to submit all food and supplement health claims prior to their use in the European Union in order to protect consumers against misleading or false advertising .The safety authority has subsequently rejected wave after wave of probiotic health claim dossiers. The industry says that the dossiers are often rejected on the basis of technicalities rather than lack of evidence. In 2008, the Euroepan commission issued guidance that indicated the authority would reject outright any scientific health claims dossier that is not based on human clinical data.EFSA from its part insists that holding probiotics to the gold standard of clinical trials is necessary to guarantee that public confidence in probiotics is based on true health benefits.

 
 
Probiotics in the marketplace
Category: Probiotics & Prebiotic

In the marketplace, an underlying fact is that not all products that are called “probiotic” are probiotic. There are numerous probiotic foods and supplements currently available. Some are more substantiated by scientific evidence than others. Regular yogurt, for example, might not have adequate levels of probiotics to provide any probiotic benefit.

It can be difficult for consumers to sort through which of these are validated probiotic products and which are not. These products make different types of relevant claims on

their labels and in advertising: content claims and health benefit claims.

In general, the best recommendation for choosing a product is to buy from a trusted company that readily shares the information with consumers and health care professionals on the content and efficacy substantiation of the products.

The following information should be available on the product label or accompanying website:

v  Given that different strains of the same species of probiotics may have different health effects, identification of the genus, species and strain of each probiotic present in the product; this approach provides a level of confidence that the product manufacturer is formulating the product with specific strains consistently over time. Furthermore, strain designations tie the product content back to the scientific publications that document claimed health effects.

v  Probiotic effects are also dose specific. It is not possible to provide one “minimum dose” that applies to all probiotics because different probiotics are effective at different levels. Assurance that the product contains the level of each

probiotic strain in the product through the end of shelf life . Levels are typically

communicated as CFUs.

v  Indication of the health benefit(s) associated with the product, including citations for published human studies have been conducted on the product or the specific strains in the product.

v  Contact information for the company

v  Product information website

v  Proper storage conditions

v  The suggested serving size or dose should be indicate based on the level showto be effective in the published studies

 
 
Probiotics safety and side effects
Category: Probiotics & Prebiotic

Many different species and strains and preparations of probiotics have been used for decades and by millions of healthy and diseased individuals, yet definitive data on safety are scanty.

In a review in 2006, Boyle and colleagues concluded that although probiotics have an excellent overall safety record, they should be used with caution in certain patient groups, particularly neonates born prematurely or with immune deficiency. They reviewed case reports of instances of abscesses and endocarditis in relation to probiotic use; in many instances the probiotic cultured from the infected tissue was most likely an innocent contaminant rather than the real pathogen.

Fears that live probiotic organisms might translocate across the gut and lead to systemic sepsis have also been allayed by the absence of such reports from studies among patients with inflammatory bowel disease and other situations where the intestinal barrier may be compromised. Two notes of caution must be mentioned. The first relates to reports of septicemia occurring among infants with short bowel syndrome, and the second to instances of increased mortality among patients with severe acute pancreatitis who had been administered a probiotic cocktail through a nasoenteric tube. These deaths were associated, not with sepsis, but with intestinal ischemia whose etiology remains unclear

A 2008 review of probiotics safety noted that Lactobacillus rhamnosus GG has been widely studied in clinical trials for a variety of conditions and generally found to be safe. Nevertheless, a recent review of Lactobacillus and Bifidobacterium biology noted that long-term, cumulative effects of probiotics use, especially in children, are unknown, and also pointed to evidence that probiotics should not be used in critically ill patients.

Similarly, a 2011 Agency for Healthcare Research and Quality assessment of the safety of probiotics, partly funded by NCCAM, concluded that the current evidence does not suggest a widespread risk of negative side effects associated with probiotics. However, the data on safety, particularly long-term safety, are limited, and the risk of serious side effects may be greater in people with compromised health are most likely to experience adverse events associated with probiotics. However, RCTs in medium-risk and critically ill participants did not report a statistically significantly increased risk of adverse events compared to control group participants.

Concerns have also been raised about the quality of probiotic products. Some products have been found to contain smaller numbers of live microorganisms than expected. In addition, some products have been found to contain bacterial strains other than those listed as ingredients.

Other issues of quality control continue to complicate the probiotic area.Does the product actually contain the organism and the dose of that organism that the label claims that it contains? Unfortunately, when researchers have analyzed some store products, they have found, not only that organisms claimed to be alive were actually dead but that the product contained organisms that it was supposed to contain.

Few studies directly compared the safety among different intervention or participant characteristics. Indirect comparisons indicated that effects of delivery vehicles (e.g., yogurt, dairy) should be investigated further. Case studies suggested that participants

There is a lack of assessment and systematic reporting of adverse events in probiotic intervention studies, and interventions are poorly documented. The available evidence in RCTs does not indicate an increased risk; however, rare adverse events are difficult to assess, and despite the substantial number of publications, the current literature is not well equipped to answer questions on the safety of probiotic interventions with confidence.

 
 
Prebiotics
Category: Probiotics & Prebiotic

Prebiotics are supplements containing a nondigestible ingredient that selectively stimulates the favorable growth or activity of one of a limited number of potentially health-promoting bacteria in the colon, most notably lactobacilli and bifidobacteria. Stimulating the growth of probiotics such as Lactobacillus or Bifidobaterium results in an increase in the absorption of vitamin and minerals, improves digestion, and increases protection against harmful bacteria, fungi and viruses.

The only prebiotics for which sufficient data have been generated to allow an evaluation of their possible classification as functional food ingredients are the inulin-type fructans, and fructo-oligosaccharides. Both are present in significant amounts in many edible fruits and vegetables, including wheat, onion, chicory, garlic, leeks, artichokes, and bananas.

Most of the evidence regarding the potential health benefits of prebiotics is derived from experimental animal studies and human trials in small numbers of subjects; there are insufficient, prospective, adequately powered studies in GI disease to permit definitive conclusions to be drawn; some recent studies suggest that prebiotics that have been designed to produce quite selective changes in the composition of the microbiota may have benefits in IBS. It must also be remembered that substances, such as fiber, fiber supplements and lactulose, for example, which have been widely employed in the treatment of constipation, exert prebiotic effects.

The use of prebiotics in preventing or treating diseases in children has not been tested extensively in RCTs, but the available evidence shows that there may be some long-term benefit for the prevention of atopic eczema and common infections in healthy infants. However, confirmatory studies, especially in children who are given formula that is not partially hydrolyzed, are needed before recommendations can be made.

 
 
 
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