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Probiotics and Health Claims

Wolfgang Kneifel (Editor), Seppo Salminen (Editor)
ISBN: 978-1-4051-9491-4
360 pages
January 2011, Wiley-Blackwell
Probiotics and Health Claims (140519491X) cover image


This book examines the international picture regarding probiotic food applications, placing a particular emphasis on the legal context and assessment procedures of probiotic health claims in the major markets for these products. Health claim legislation is described and the ways in which manufacturers can ensure compliance are discussed. The book also covers the use of meta-analysis to assess available data, and case examples from various regulatory cultures and traditions are included. It will be of interest to food industry scientists, executives and R&D personnel; international regulatory advisers and administrators; researchers, educators and students on food science courses.

Key Features:

  • Focuses on health claim legislation for this commercially important food sector
  • Includes chapters on the current situation in all the major world markets including Europe, the USA, Japan, India and China
  • Covers food, feed and pharmaceutical applications of probiotics
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Table of Contents



1 Probiotics and Health: From History to Future (Barry R. Goldin).

1.1 Early history of the use of microorganisms for human benefit.

1.2 Overview of probiotic studies and results for the past years.

1.3 Current evidence for probiotic health benefits.

1.3.1 Lactose intolerance.

1.3.2 Inflammatory bowel disease.

1.3.3 Treatment of gastroenteritis.

1.3.4 Cholesterol lowering.

1.3.5 Treatment for urogenital infections.

1.3.6 Treatment of allergic reactions.

1.3.7 Prevention of dental caries.

1.3.8 Treatment and prevention of cancer by probiotics.

1.3.9 Additional health benefits attributed to probiotics.

1.3.10 Conclusions based on past and present use of probiotics for health applications.

1.4 Nutritional effects of probiotics.

1.5 Future development and uses of probiotics for health application.

1.5.1 Probiotics as a platform for delivery of drugs, enzymes, hormones, nutrients and micronutrients.

1.5.2 Toxin sequestration.

1.5.3 Carcinogen detoxification.

1.5.4 Antibody production.

1.5.5 Treatment for enzyme deficiencies.

1.5.6 Other potential future directions for probiotics for medical use.

1.6 Conclusions.

2 The World’s Oldest Probiotic: Perspectives for Health Claims (Tomoyuki Sako).

2.1 From theory to practice: the challenge of Dr Minoru Shirota.

2.1.1 The discovery of Lactobacillus casei strain Shirota.

2.1.2 Early studies in Japan: the first clinical study era for Yakult and L. casei Shirota.

2.1.3 Probiotic definition and the L. casei Shirota strain.

2.2 Health benefits of Yakult and L. casei Shirota.

2.2.1 Identification and characterisation of L. casei Shirota.

2.2.2 Beneficial modulation of the intestinal microbiota.

2.2.3 Improvement of stool consistency .

2.2.4 Protection from infection.

2.2.5 Immune modulation activity.

2.2.6 Prophylactic effect of L. casei Shirota on cancer development.

2.3 Safety.

2.4 Health claims for L. casei Shirota and the product Yakult.

2.5 Current perspectives.

3 Probiotics: from Strain to Product (Arthur C. Ouwehand, Lisbeth Søndberg Svendsen and Gregory Leyer).

3.1 Introduction.

3.2 Isolating a potential probiotic strain.

3.3 Producing probiotic strains on a large scale.

3.4 Producing products containing probiotics.

3.4.1 Fermented milk products.

3.4.2 Cheese.

3.4.3 Non-fermented milk drinks.

3.4.4 Fruit and vegetable juices.

3.4.5 Dried products.

3.5 Probiotic products and feeding trials.

3.6 Conclusion.

4 Probiotics and Health Claims: Challenges for Tailoring their Efficacy (Christophe Chassard, Franck Grattepanche and Christophe Lacroix).

4.1 Introduction.

4.2 Current selection of probiotics: setting the scene for tailoring probiotics.

4.2.1 Safety considerations.

4.2.2 Technological considerations.

4.2.3 Functionality and health benefits.

4.3 Improving the assessment of probiosis.

4.3.1 In vitro models for the assessment of probiosis.

4.3.2 In vivo models for the assessment of probiosis.

4.3.3 Clinical trials for the assessment of probiosis.

4.4 Improving the discovery of probiotic strains

4.4.1 Exploring and isolating bacterial diversity.

4.4.2 New generations of probiotics from new bacterial genera and with new targeted functions.

4.5 Improving probiotic specificity.

4.5.1 Future therapeutic strategies: combination of strains?

4.5.2 Nutritional manipulation.

4.5.3 Genetic engineering.

4.6 Conclusions.

5 Probiotics: from Origin to Labeling from a European  and Brazilian Perspective. (Célia Lucia Ferreira, Marcos Magalhães, Miguel Gueimonde and Seppo Salminen).

5.1 Introduction.

5.2 Terminology and probiotics.

5.3 Health claim regulation in the European Union.

5.4 Health claims in Europe.

5.5 Health claim regulation in Brazil.

5.6 Defining health claims.

5.6.1 Characterization of probiotic bacteria.

5.6.2 Safety assessment.

5.6.3 Human intervention studies for health claims.

5.6.4 Totality of supporting evidence.

5.7 Specific challenges for probiotics.

5.7.1 Viability.

5.7.2 Clinical studies demonstrating efficacy of probiotics in healthy subjects.

5.7.3 Challenges in regulatory areas.

6 Substantiating Health Benefit Claims for Probiotics in the United States (Mary Ellen Sanders).

6.1 Introduction.

6.1.1 Probiotics and health benefits.

6.1.2 Probiotics: a term often misused.

6.2 Health benefit claims allowable in the United States.

6.2.1 FDA and FTC standards.

6.2.2 Structure/function claims.

6.2.3 Health claims.

6.2.4 Medical food claims.

6.3 Substantiation of health benefit claims for probiotics.

6.3.1 Overriding considerations.

6.3.2 Specific issues related to human efficacy studies.

6.3.3 Key considerations for probiotic efficacy substantiation.

6.4 Bridging the gap between the US consumer, probiotic science and commercial products.

6.5 Conclusions.

7 Health Claims and Dietary Guidance in the United States: Case "Reduced Cardiovascular Disease Risk" (Alice H. Lichtenstein).

7.1 Introduction.

7.2 Types of health claims.

7.2.1 Definition.

7.2.2 Authorized health claims.

7.2.3 Qualified health claims.

7.2.4 Structure/function claims.

7.2.5 Nutrient content claims.

7.3 Legislation governing US health claims.

7.3.1 Nutrition Labeling and Education Act (NLEA).

7.3.2 Food and Drug Administration Modernization Act (FDAMA).

7.3.3 Consumer Health Information for Better Nutrition Initiative (2003).

7.4 Dietary guidance to reduce cardiovascular disease risk.

7.4.1 Dietary Guidelines for Americans.

7.4.2 National Cholesterol Education Program.

7.4.3 Dietary Reference Intakes.

7.4.4 American Heart Association.

7.4.5 American Diabetes Association.

7.4.6 American Cancer Society.

7.4.7 Case study: evolution of Dietary Guidelines for Americans.

7.5 Current challenges.

8 Probiotics and Health Claims: a Japanese Perspective (Fang He and Yoshimi Benno).

8.1 Introduction.

8.2 FOSHU health claims.

8.2.1 History of FOSHU.

8.2.2 Specifics of FOSHU health claims.

8.2.3 Procedure for obtainining permission for FOSHU.

8.2.4 FOSHU health claim for probiotics: gastrointestinal conditions.

8.3 Non-FOSHU health claims for probiotics in Japan.

9 Regulation of Probiotics in China (Anu Lahteenmäki-Uutela).

9.1 Introduction.

9.2 Health food or medicine?

9.3 Health food regulations.

9.4 Novel food regulation.

10 Probiotics and Health Claims: an Indian Perspective (Jashbhai B. Prajapati and Nagendra P. Shah).

10.1 The background.

10.2 The status.

10.3 Animal studies.

10.3.1 Chicken.

10.3.2 Albino rats.

10.3.3 Pigs.

10.3.4 Sheep.

10.3.5 Calves.

10.3.6 Fish.

10.3.7 Post-larvae.

10.4 Human studies.

10.4.1 Probiotics in gut microbiology.

10.4.2 Probiotics in diarrheal diseases.

10.4.3 Effects on lipid profile.

10.4.4 Morbidity and nutritional status.

10.5 An Indian perspective on regulation of probiotics.

11 The Role of Meta-analysis in the Evaluation of Clinical Trials on Probiotics (Hania Szajewska).

11.1 Introduction.

11.2 What is a systematic review? What is a meta-analysis?

11.3 How to conduct a systematic review.

11.3.1 Formulation of the review question (the problem).

11.3.2 Searching.

11.3.3 Selecting studies and collecting data.

11.3.4 Assessment of methodological quality (i.e. the risk of bias in included trials).

11.3.5 Analysing the data and presenting the results.

11.4 Why perform a meta-analysis?

11.5 Heterogeneity.

11.6 How to interpret a forest plot.

11.7 Critical appraisal of a systematic review.

11.8 Published meta-analyses on the effects of probiotics.

11.8.1 Acute gastroenteritis.

11.8.2 Antibiotic-associated diarrhea.

11.8.3 Clostridium difficile-associated diarrhea.

11.8.4 Traveler’s diarrhea.

11.8.5 Necrotizing enterocolitis.

11.8.6 Helicobacter pylori infection.

11.8.7 Functional gastrointestinal disorders.

11.8.8 Irritable bowel syndrome.

11.8.9 Inflammatory bowel disease.

11.8.10 Functional constipation.

11.8.11 Allergy prevention.

11.8.12 Respiratory tract infections.

11.9 Is a meta-analytical approach appropriate for assessing the efficacy of probiotics?

11.9.1 Arguments for pooling data.

11.9.2 Arguments against pooling data.

11.10 What could be the solution?

11.11 Unpublished data.

11.12 Quality of included trials.

11.13 Inconclusive systematic reviews and meta-analyses.

11.14 Opposite conclusions.

11.15 Summary and key messages.

12 Applied Studies with Probiotics: Fundamentals for Meeting the Health Claims (Hannu Mykkänen, Silvia W. Gratz and Hani El-Nezami).

12.1 Introduction.

12.2 Mycotoxin problem.

12.3 Lactobacillus rhamnosus strain effectively binds aflatoxin: in vitro findings.

12.4 Animal models for studying the aflatoxin–probiotic interaction.

12.5 Field studies with Lactobacillus rhamnosus strain in aflatoxin-exposed populations.

13 Probiotics Research: the Pediatric Perspective (Karl Zwiauer).

13.1 Introduction.

13.2 Development of the gastrointestinal flora postnatally.

13.3 Probiotics in infant nutrition.

13.3.1 Growth of healthy infants.

13.3.2 Probiotics in preterm infants.

13.3.3 Safety concerns.

13.4 Clinical effect of probiotics in children.

13.4.1 Prevention of allergic disease: food hypersensitivity.

13.4.2 Atopic dermatitis.

13.4.3 Prevention of antibiotic-associated diarrhea.

13.4.4 Acute gastroenteritis and community-acquired diarrhea.

13.4.5 Irritable bowel syndrome and constipation.

13.4.6 Infantile colic.

13.4.7 Inflammatory bowel disease.

13.4.8 Oral health effects: caries.

13.4.9 Other clinical conditions.

13.5 Summary and key messages.

14 Probiotics and Health Claims Related to OTC Products and Pharmaceutical Preparations (Frank M. Unger and Helmut Viernstein).

14.1 Introduction.

14.2 Production, processing and formulation of probiotic cultures for pharmaceutical purposes.

14.3 Clinical studies.

14.3.1 Gastroenterology.

14.3.2 Gynecology.

14.3.3 Dentistry/stomatology.

14.4 Evaluation and outlook.

14.4.1 Antibiotic-associated diarrhea and Clostridium difficile disease.

14.4.2 Traveler’s diarrhea.

14.4.3 Helicobacter pylori infection.

14.4.4 Lactose intolerance.

14.4.5 Irritable bowel syndrome.

14.4.6 Ulcerative colitis.

14.4.7 Pouchitis.

14.4.8 Crohn’s disease.

14.4.9 Bacterial vaginosis.

14.4.10 Gingivitis, reduction of plaque and alleviation of gum bleeding.

14.4.11 Selected experimental approaches to probiotic products with new properties and in new indications.

15 Probiotics and Health Claims: the Perspective of the Feed Industry (Anja Meieregger, Elisabeth Mayrhuber and Hans Peter Lettner).

15.1 Introduction and history.

15.2 Feed probiotics versus food probiotics.

15.2.1 Gram-positive non-sporulating bacteria.

15.2.2 Bacillus species.

15.2.3 Yeasts.

15.2.4 Filamentous fungi.

15.3 Efficacy.

15.4 Feed probiotics.

15.4.1 Fundamentals.

15.4.2 Industrial production.

15.5 Authorisation processes.

15.6 Probiotics as performance enhancers: conclusions.

16 Developing LGGExtra, a Probiotic Multispecies Combination (Maija Saxelin, Eveliina Myllyluoma and Riitta Korpela).

16.1 Introduction.

16.2 Strain selection.

16.3 Probiotic characteristics of the strains.

16.3.1 Gastrointestinal persistence and colonisation.

16.3.2 Influence on human intestinal microbiota.

16.3.3 Immunological effects in vitro.

16.3.4 Potential for reducing dietary toxins.

16.3.5 Safety aspects.

16.4 Clinical studies on the probiotic multispecies LGG®Extra combination.

16.4.1 Relieving symptoms of irritable bowel syndrome.

16.4.2 Eradication of Helicobacter pylori and Candida

16.4.3 Other research areas.

16.5 Conclusions.

17 Probiotics and Health Claims: How to Be Met by SMEs? (Miguel Gueimonde and Sampo J. Lahtinen).

17.1 Introduction.

17.2 Developing proprietary probiotic strains.

17.3 Probiotic research by SMEs using strains from larger companies.

17.4 Example of successful probiotic research program by an SME company: the development of probiotic strains Bifidobacterium longum and B. longum C

18 Probiotic Products: How Can They Meet the Requirements? (Wolfgang Kneifel).

18.1 Introduction.

18.2 Quality criteria of probiotics.

18.2.1 Basic composition and nutrient profile.

18.2.2 Nature, identity and safety of probiotic strains.

18.2.3 Viability and probiotic viable count.

18.3 Future perspectives.

19 Probiotics and Health Claims: Hurdles for New Applications? (Lorenzo Morelli).

19.1 Introduction.

19.2 Identifying the hurdles.

19.2.1 Characterisation.

19.2.2 Relationship to health.

19.2.3 Scientific substantiation.

19.3 Approaching the hurdles.

19.3.1 Hurdle characterisation.

19.3.2 Relationship to health.

19.3.3 Scientific substantiation.

19.4 New perspectives.

19.4.1 General considerations.

19.4.2 Functional genomics.

19.5 Conclusions.

20 Probiotics and Innovation (Jean-Michel Antoine, Jean-Michel Faurie, Raish Oozeer, Johan van Hylckama Vlieg, Jan Knol, Herwig Bachmann and Joël Doré).

20.1 Introduction.

20.1.1 Early history.

20.1.2 Recent history.

20.2 Not all probiotics are the same: genomic perspective.

20.3 Not all probiotic foods are the same: functional perspective.

20.4 Not all probiotics are cross-talking in the same way: dialogue with the host.

20.4.1 Dialogue with the human intestinal microbiota: a logical trigger for innovation.

20.4.2 Novel functional targets for the human intestinal microbiota.

20.5 European regulatory perspective: a threat or an opportunity?

20.5.1 European regulatory perspective: a threat?

20.5.2 For innovation in probiotics, the present regulatory requirements are an opportunity.

20.6 Conclusion.


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Author Information

Wolfgang Kneifel is Professor for Food Quality Assurance at BOKU, Vienna.

Seppo Salminen is Professor and Head of the Functional Foods Forum at the University of Turku, Finland

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"It is not intended primarily for gastroenterologists, although it does contain some insights that clinicians will find useful ... For these alone, the book can be recommended to those who struggle with supporting health claims for probiotics." (Gastroenterological, 1 November 2011)

"In conclusion, I consider this book to be a must-have for all those evaluating their favourite strains with respect to claim substantiation. As intended by the editors, it allows for a comparison of health claims systems in different regions of the world. It contains helpful remarks with respect to putting together a dossier and is therefore imperative in your library of probiotic reference books." (Beneficial Microbes, 1 June 2011)


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Press Release

March 10, 2011
Probiotics and Health Claims by Wolfgang Kneifel and Seppo Salminen

The medical benefits of probiotics or ‘friendly bacteria’ are not new; thousands of years ago people drank sour milk as a cure for stomach complaints. Yet, as more and more probiotic products hit our shelves what is the scientific basis for their health benefit claims?

In their new title, Probiotics and Health Claims Wolfgang Kneifel and Seppo Salminen explore the scientific standards, the legal framework, the history of friendly bacteria, and the industry it has inspired.

“Probiotics have a long history in nutrition and medicine,” said Kneifel. “However, the health benefits have only been demonstrated recently, following the application of proven standards of clinical assessment.”

Probiotics and Health Claims navigates the controversial health claim regulations, which have promoted intense debate by experts, the public and legislators from the European Union, the United States and China.

The authors emphasise the legal context and assessment procedures of probiotic health claims in the major markets for these products. Health claim legislation is explored to discover how manufacturers ensure compliance.

Probiotics and Health Claims offers an overview of the many scientific areas and viewpoints involved in the health claims debate, resulting in an invaluable resource for researchers, consulting experts, regulators and food developers.

“In recent years many new probiotic applications have emerged across the world, both for food and pharmaceutical science, and it is important to evaluate and understand the scientific standards for the many health claims made,” concluded Kneifel. “Through this book we have brought experts together from across the global markets to achieve that goal.”

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