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Dutch firm upgrades EU probiotic (medical devices) claim

By Shane Starling+

07-Jan-2014

A probiotics specialist in the Netherlands has won a second claim for a multi-strain probiotic blend targeting vaginal health under European Union medical devices legislation.

Dutch firm Winclove Probiotics previously won a vaginal infection claim for its Ecologic FEMI+ product under the same route in 2009, but the product has not yet been commercialised.

Winclove researcher Yorick Tromp told us the company re-applied for the claim through Dutch authorities about a year ago as the blend had been altered to boost shelf life and stability.

“We replaced two of the Lactobacillus strains with two others from the same family and this has meant the shelf life of the product has been increased from one to two years,” Tromp said.

“We also changed the excipient.”

Tromp said the firm had to answer many ‘mechanism of action’ and other questions from the Dutch agency, DEKRA (formerly KEMA), in winning the medical devices authorisation that applies across the EU’s 28 member states.

The route has permitted other claims denied under the EU nutrition and health claims regulation (NHCR) such as for cranberry (urinary tract infections) and chitosan (cholesterol management). See more on that here .

The product is said to be applied topically and was backed by in vitro studies.

Strains in the blend include: L. plantarum, L. salivarius, Bifidobacterium bifidum, L. brevis and L. acidophilus.

The official claim

“Winclove Ecologic® FEMI+ is a medical device, containing a number of beneficial lactic acid producing bacteria, for topical vaginal application, which is intended to enhance the natural vaginal flora by preventing or alleviating any imbalance in this flora, thus inhibiting the growth of pathogens and thereby preventing the occurrence or recurrence of vaginal infections such as vaginosis and vaginitis.

“It achieves this principally by promoting the formation of lactic acid, the production of hydrogen peroxide, and competition with potential pathogens for space and substrate.”

Winclove said the blend had been shown to:

  • inhibit growth of C. albicans (two different strains) and C.glabrata
  • promote production of hydrogen peroxide (H2O2)
  • promote lactic acid production.

Vaginosis can lead to vaginal infection which can result in unpleasant odours as well as itching, swelling, irritation and stomach cramps.

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