The claim, which has been approved by the independent Dutch certification agency, KEMA, is as a Class IIa Medical Device and states: “Ecologic FEMI+ can be used to enhance the natural vaginal flora by preventing or alleviating any imbalance in this flora, thus inhibiting growth of pathogens and preventing the occurrence or recurrence of vaginal infections such as vaginosis and vaginitis.”
Linda Mulder, Winclove’s head of research and development, said the KEMA certification meant the claim on Ecologic FEMI+ could be used in other European jurisdictions, despite the fact no clinical trials had yet been conducted with the product.
“The claim certification is based on a pilot study, several in vitro studies and clinical trials conducted with similar products,” Mulder told NutraIngredients.com this morning. “Further studies have been commissioned but it was not necessary to have any clinical trials for this claim.”
The pilot study was in collaboration with the St Elisabeth Hospital in the Netherlands. It showed 70 per cent of women suffering from recurrent vaginal infection, improved their condition after using Ecologic FEMI+.
The market for products offering vaginal infection relief is growing at about 10 per cent per annum, according to estimates.
Product development
Winclove has been developing the product since 2004 and experimented with more than 30 probiotic strains before determining the combination of six strains its scientists and formulators found to be the most effective in combating vaginosis and vaginitis.
The six strains: Bifidobacterium bifidum, Lactobacillus plantarum, L. acidophilus, L. rhamnosus, L. salivarius and L. casei include a Winclove version of one (L. rhamnosus) of the two strains highlighted as being most efficacious by the leading researcher and developer in the area – Professor Gregor Reid. The other is L. reuteri.
But it should be noted that not all probiotic strains are the same - and Winclove's version of L. rhamnosusis is not necessarily the same as those studied by Professor Reid or others.
Mulder said the product came in capsule form and contained 875m colony forming units of the combined probiotic strains, of which it was recommended two be consumed per day to effectively battle problematic flora such as Gardnerella vaginalis, Candida albicans and C. glabrata.
Ecologic FEMI+ also contains lactoferrin.
Professor Reid’s Canadian-based vaginal supplements company, Urex Biotech, was bought last year by Danish supplier, Chr Hansen, for an undisclosed fee.
His research has indicated a course of supplements employing particular strains of L. rhamnosus and L. reuteri can yield benefits in 3-5 days. That research had indicated 1bn organisms per supplement was an ideal number.
Vaginosis can lead to vaginal infection which can result in unpleasant odours as well as itching, swelling, irritation and stomach cramps
Winclove has been active in probiotics for more than 15 years.