Barbie Hall had tried yogurt boosted with probiotics, those so-called friendly microorganisms that commercials promised would regulate her digestive system within weeks. They did no such thing.
After excessive Googling, she searched for a probiotic supplement, but she had little preference about which one — she bought the cheapest jar in the vitamin aisle of her local CVS. Two months later, Hall is convinced the once-a-day pill has cured her chronic stomach pain and irregularity.
"I can't say if these claims are made up or exaggerated, but all I know is it works for me," said Hall, 28, of Taneytown.
Devotees of probiotics, used in candy bars, smoothies and even fancy moisturizers, say the same, and their enthusiasm is likely the reason for the booming industry in recent years. But researchers at the University of Maryland say it's time to take a step back and examine whether probiotics are worthy of the hype — and if they're not, to consider tougher regulation. With funding from the National Institutes of Health, researchers at the university's law and medical schools are leading a team of attorneys, scientists and industry experts for a three-year investigation into the health claims of probiotics.
"It's one thing to buy something because you think it tastes good, but it's another thing if you buy it because you believe it has health properties," said Diane Hoffmann, director of the Law and Health Care Program at the University of Maryland's law school, who is leading the research. "On the flip side, to the extent that these products are beneficial and therapeutic, we don't want to over-regulate them and stifle their development and people's ability to access them in the marketplace."
Probiotics are bacteria that exist naturally in some food, like yogurt, or they may be added to food and other products. Different kinds of bacteria may have different uses, but generally they help promote the good bacteria found in the intestinal tract.
While most products are marketed as digestive aids and treatment for gastrointestinal problems, a growing variety claim to boost immunity, prevent illness and even keep skin clear, fresh and young. Products promoting the health benefits of "live cultures," in brands from Dannon to GNC, are everywhere.
But there is no standard for helping consumers make sense of what probiotics do and how they differ, say Maryland researchers. Despite claims made on food and supplement labels, the field of study of these microbes is still in its infancy.
While they appear to be safe and hold promise for understanding the naturally occurring bacteria in the body, more study is needed on which types of probiotics are effective for treating which conditions, researchers say. And new findings are muddying the waters even more: Researchers think two people can take the same probiotic for the same ailment and have considerably different results.
"It's not really obvious to anybody yet what strains of bacteria are best," said Claire Fraser-Liggett, director of the Institute for Genome Sciences at the University of Maryland School of Medicine, and a researcher on the project. "It could be that different strains are better for different people. We don't know."
The U.S. Food and Drug Administration treats most probiotics as food or supplements. They don't require pre-approval from the agency. But companies must be truthful about their claims and they can't say a product is effective at mitigating or treating disease.
Still, oversight of those rules is spotty, said microbiologist Mary Ellen Sanders, executive director for the International Scientific Association for Probiotics and Prebiotics, which aims to promote the science behind probiotics.
"They don't seem to have the resources or the will to go after every product on the market and say 'show us substantiation for the claims you're making,' " she said. Consumers are often left confused about what works and what doesn't, she said. "There's just not enough independent, third-party information out there for them to make easy choices."
Patients often come to Dr. Linda A. Lee's office at Johns Hopkins confused about probiotics — should they try them, and if so, which ones? Some have experimented with them, others desperately want to know which ones she recommends. Her advice: It's hard to say.
Some studies have shown probiotics to help such gastrointestinal problems as antibiotic-related diarrhea, moderate ulcerative colitis — a type of inflammatory bowel disease — and bloating, said Lee, director of Hopkins' Integrative Medicine & Digestive Center. She often recommends drugs and traditional therapies, gives advice about diet, then tells patients what she knows about probiotics and leaves the decision to them.