Oral Probiotics: An Introduction [NCCAM Health Information]

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Oral Probiotics: An Introduction [NCCAM Health Information]

On this page:

• Introduction
• Key Points
• Background
• Use of Probiotics in the United States
• Status of Probiotics Research
• Safety and Side Effects
• If You Are Thinking About Using Probiotics
• NCCAM-Funded Research on Probiotics
• References
• For More Information
• Acknowledgments

Introduction

Probiotics are live microorganisms (e.g., bacteria) that are either the same as or similar to microorganisms found naturally in the human body and may be beneficial to health. Also referred to as "good bacteria" or "helpful bacteria," probiotics are available to consumers in oral products such as dietary supplements and yogurts, as well as other products such as suppositories and creams. The U.S. Food and Drug Administration (FDA) has not approved any health claims for probiotics. This fact sheet provides a general overview of probiotics, with an emphasis on oral products, and suggests sources for additional information.

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Key Points

• Probiotic products are widely marketed, and consumer interest in probiotics is growing rapidly. Although some probiotic formulations have shown promise in research, strong scientific evidence to support specific uses of probiotics for most conditions is lacking.
• Probiotics have potential applications in many areas of human health, and research to gather scientific evidence about whether and how they work is moving forward. Additional clinical studies are needed to investigate the safety and efficacy of probiotics for specific uses.
• If you are thinking about using a probiotic dietary supplementA product that contains vitamins, minerals, herbs or other botanicals, amino acids, enzymes, and/or other ingredients intended to supplement the diet. The U.S. Food and Drug Administration has special labeling requirements for dietary supplements and treats them as foods, not drugs., consult your health care provider first. Probiotics—like any form of complementary medicine—should not be used in place of conventional medical care or to delay seeking care if you are experiencing symptoms that concern you.
• Tell all your health care providers about any complementary approaches you use. Give them a full picture of what you do to manage your health. This will help ensure coordinated and safe care.

Background

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. Microorganisms are invisible to the naked eye and exist virtually everywhere. Scientists continued to investigate the concept, and the term "probiotics"—meaning "for life"—eventually came into use.
Picturing the human body as a "host" for bacteria and other microorganisms is helpful in understanding probiotics. The body, especially the lower gastrointestinal tract (the gut), contains a complex and diverse community of bacteria. (In the body of a healthy adult, cells of microorganisms are estimated to outnumber human cells by a factor of ten to one.) Although we tend to think of bacteria as harmful "germs," many bacteria actually help the body function properly. Most probiotics are bacteria similar to the beneficial bacteria found naturally in the human gut.
Various mechanisms may account for the effects of probiotics on human health. Possible mechanisms include altering the intestinal "microecology" (e.g., reducing harmful organisms in the intestine), producing antimicrobial compounds (substances that destroy or suppress the growth of microorganisms), and stimulating the body's immune response.
Probiotics commonly used in the United States include Lactobacillus and Bifidobacterium. There are many specific types of bacteria within each of these two broad groups, and health benefits associated with one type may not hold true for others.

Probiotics, Prebiotics, and Synbiotics

Probiotics are not the same as prebiotics—nondigestible substances that stimulate the growth and/or activity of potentially beneficial microorganisms. The term "synbiotics" refers to products that combine probiotics and prebiotics.

Use of Probiotics in the United States

In the United States, probiotics are available as dietary supplements (including capsules, tablets, and powders) and in dairy foods (such as yogurts with live active cultures). According to the 2007 National Health Interview Survey, which included questions on Americans' use of natural products other than vitamins and minerals, "prebiotics/probiotics" ranked fifth among natural products used for children, but were not among the top-ranking products for adults. Although probiotic products are more popular in Europe and Japan than in the United States, the U.S. consumer market for probiotics is growing rapidly.
Although the FDA has not approved any health claims for probiotics, they are used for a variety of gastrointestinal conditions such as infectious diarrhea, diarrhea associated with using antibiotics, irritable bowel syndrome, and inflammatory bowel disease (e.g., ulcerative colitis and Crohn's disease). Probiotics are also being used for preventing tooth decay and for preventing or treating other oral health problems such as gingivitis and periodontitis. Some—but not all—probiotic formulations have been widely studied and show considerable promise. However, the rapid growth in marketing and consumer interest and use has outpaced scientific research on the safety and efficacy of probiotics for specific health applications.

Government Regulation of Probiotics

Government regulation of probiotics is complex. Depending on a probiotic product's intended use, the FDA might regulate it as a dietary supplement, a food ingredient, or a drug. Many probiotic products are sold as dietary supplements, which do not require FDA approval prior to marketing. Dietary supplement labels may make claims about how the product affects the structure or function of the body without prior FDA approval, but they cannot make health claims (claims that the product reduces the risk of a disease) without the FDA's consent. (For more information about dietary supplements, see Using Dietary Supplements Wisely.) A product that is marketed as a drug must meet more stringent requirements. It must be proven safe and effective for its intended use through clinical studies (tests in people) and be approved by the FDA before it can be marketed.