European Food Safety Authority Rejects Prostora, a Probiotic Product for Dogs

I have written frequently about probiotics,(1,2) and the health effects of microorganisms seems a promising area of research. The current evidence for meaningful beneficial effects, however, is quite limited. There is reasonable evidence for some benefit in treating antibiotic-associated diarrhea or acute diarrhea of unknown cause(3). The evidence is not very good for many other claimed benefits, such as strengthening of immune system function, treatment of kidney disease(4,5), management of feline upper respiratory viral infections(6), and so on. And there are serious problems with irresponsible, excessive hype(7) and poor quality control(8) for probiotics.

One product I have written about, and used in my own patients, is Prostora from the Iams company. This product is attractive in several ways. It has good quality control and some supportive clinical trial evidence. However, I recently ran across an evaluation of the product produced in 2012 by the European Food Safety Authority (EFSA), which rejected the company’s application for approval to market Prostora in the European Union.

In terms of the efficacy of the product, the EFSA concluded that it could not reach a definitive judgment. According to the report, eight research studies were submitted in support of efficacy. Five of these were rejected for inadequate methodology (lack of a control group, for example). The three evaluated (including one I have reviewed here) did show some evidence of a beneficial effect. However, the effects were inconsistent and not always strong enough to be meaningful even if statistically significant.

More interesting to me was the concern raised in the report about the issue of antibiotic resistance. Apparently, the organism in Prostora has shown some resistance to the antibiotic clindamycin. A number of genes that confer antibiotic resistance have been identified, and some of these can be transmitted from one bacterium to another. The specific source of the resistance to clindamycin seen in the Prostora bacterium is not known, so it is not clear if this resistance could be transmitted to other bacteria in animals or people exposed to Prostora.

Because of this uncertainty, and the serious and growing problem of antibiotic resistance in infectious organisms, the EFSA chose not to approve the sale of Prostora in the EU. It has been approved here in the U.S. under the much less strict laws governing dietary supplements.

The EFSA in general has taken a conservative stance on probiotics, which some argue is appropriate based on the currently available evidence, and which others, notably probiotic manufacturers, have claimed ignores relevant science. There is some scientific evidence indicating that antibiotic resistance can be exacerbated by the use of probiotic organisms with such resistance, though the extent of the risk is not well-documented.

As I have often said about probiotics, because they clearly have the ability to affect the health of people and animals, they undoubtedly have risks as well as benefits. The devil is in the details, and they should neither be rejected out of hand nor embraced unquestioningly as beneficial. The specific risks and benefits of particular organisms for particular health conditions in particular species have to be understood through the careful and laborious process of scientific research. There is nothing intrinsically “alternative” about the use of microorganisms to affect health, but the indiscriminate use of them in the absence of appropriate scientific evaluation would be a mistake in the tradition of the worst kind of alternative medicine.

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16 Responses to European Food Safety Authority Rejects Prostora, a Probiotic Product for Dogs

  1. Art says:

    Probiotics and fecal transplants are going to have risk as well as benefits. Remember being taught in school it is safer to kiss your dog than another human. I sold probiotics in my practice years ago but now if owners want them I tell them I would just feed yogurt with “natural” cultures. That way the patient is at least getting calories. When yogurt first became popular in the pre Dannon days I remember the bacteria in the yogurt was killed before sold. Dannon now must promote non clindimycin resistant “natural” cultures.

  2. Feances says:

    I personally found live yoghurt very effective when suffering from AB induced problems while undergoing chemotherapy. The dogs get green tripe – I hope enough of the beneficial bacteria survive freezing to be effective (not something I ever intend to try myself, however, no matter how bad my symptoms might be!).

  3. Diane says:

    Very interesting; it never occurred to me that probiotics could have a negative effect.

  4. petra lipp says:

    pls recommend treatment for tearstain. changed my mind about angel eyes, since it conains Tylosin Waiting for your suggestions Thanks Regards Petra Lipp

  5. skeptvet says:

    I don’t really have a recommendation since there isn’t a well-demonstrated, science-based therapy for this. Given it is really just a cosmetic issue, there isn’t likely to be much research on such treatments. Lots of anecdotal reports for lots of things, but you always roll the dice when using anecdote to guide you.

  6. Emily says:

    My vet said Prostora trials showed an off-label benefit of decreasing red tear staining. I’m trying it on my bichon, and it has been helping, so I’m sorry to learn Iams is going out of business and it is being discontinued.

  7. skeptvet says:

    Well, technically there is no “off-label” use since it does not have a “label,” meaning FDA approval for medical use. As a supplement, that is not required. There have been some good studies showing benefits for diarrhea, so I too was saddened that it was taken off the market. The tear-staining claim was entirely anecdotal, and I’ve had a lot of clients who haven’t seen any benefit, so that is one that was never clearly demonstrated.

  8. kate says:

    I was so upset to discover that prostora is discontinued. I have a 16 year old shih tzu who had GI issues on and off most of her life (diarrhea). Prostora has been a life saver for us – it’s the only this that works for her and it works fast. Is there another product you can recommend to take it’s place. I can’t find prostora anywhere on line & I don’t know what to do if she gets sick.

  9. skeptvet says:

    Yes, it’s unfortunate Prostora is no longer available since it was one of the products with good quality control data. The other that seems to have some consistency in terms of what is on the label compared to what is in the product, is Fortiflora, though it’s a different organism in a different form, so there’s no way to know if it will have the same effects as Prostora might in any given case. Most of the products out there are untested and unregulated, so it’s a bit of a roll of the dice.

  10. Kate says:

    What do you think of Purina’s Fortiflora?
    Does is work the same way as Prostora? I called the vet’s office & they said this is the probiotic they now give dogs. I appreciate your input.

  11. Kate says:

    Sorry – I hadn’t noticed your earlier response (where you mentioned Fortiflora).
    Thanks – just wondering if it is given the same way to dogs as prostora was. I know some probiotics are given as a daily supplement. I need something that is just for diarrhea.

  12. skeptvet says:

    I know that Fortiflora has good quality control, so at least it reliably contains the active organism on the label. Beyond that, there are a few studies suggesting some benefits for diarrhea, though the evidence isn’t as strong as it was for Prostora before that went off the market. I use Fortiflora as my probiotic of choice now that Prostora is no longer available.

  13. Terry says:

    We too were very disappointed to see IAMS prostora go off the market. We tried it for the red tear stain on our minature poodle. It was great and has been working for many years. Within about a week of discontinuance, the red stains reappeared. We have tried Proflora, but there has been no improvement at all. I think we will give Fortiflora and see if it has any effect.

  14. Patty says:

    I bought the alteratve suggested probiotics. They do NOT help with diareah. My GSD has been taking the prostora for eight years when tummy trouble arrives. Within 24 hours the Ian’s Prostora worked every single time. I’m so. Entry bummed that this product is no longer available. My boy hates the new probiotics.

  15. AKaBooM says:

    I too am a pet owner frustrated by Mars’ decision to no longer manufacture Iams Prostora Max. My wish for is that they sell the technology and processing information to another company, but that will not likely happen. The data was good, more importantly the results both clinical and anecdotal spoke volumes. Using this single-strain canine-derived means no additional competition from other bacteria, and again, it works. I have been giving a maintenance dosage to my lymphoma dog for YEARS (yes, years, a typical b-cell case with atypical longevity of 8.5 years so far) along with prebiotic FOS – both help support GALT immune system health. I may have to beg a friend to formulate a reverse-engineered product!

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