About FemiBiotic™

Probiotics for Women

FemiBiotic™ is a probiotic dietary supplement supporting vaginal health with two proprietary probiotic strains:

  • Lactobacillus rhamnosus PB01
  • Lactobacillus gasseri EB01
Our patented probiotic for women is a potent formula with active bacterial strains, designed to improve vaginal health.

 

  • Potent Lactobacillus formula for women
  • Powerful probiotics that help improve vaginal health
  • Slow-release capsules for better absorption and maximum potency
  • Purity, potency and quality guaranteed

An acid resistance capsule formulation ensures targeted delivery of viable probiotics. FemiBiotic™ is manufactured in cGMP FDA Approved Facility.

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The vaginal microbiota
It has been known for many years that the vaginal microbiota plays a crucial role in maintaining vaginal health. Generally, a normal vaginal microbiota is dominated by Lactobacillus species. The lactobacilli live side by side with yeast and anaerobic bacteria, constituting a balanced microbial environment. Major changes in the normal vaginal microbiota can lead to different conditions, of which bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) are some of the most prevalent types affecting vaginal health (Al-Ghazzewi 2016). Estimates on BV prevalence ranges from 19% to 24% in European countries and from 23% to 51% in the US, depending on ethnicity (Bautista 2016). Estimates on VVC prevalence suggest that 75% of all women at childbearing age will be afflicted at least once in their lifetime. Of these, approximately 5-8% suffers from recurrent VVC (Peters 2014).

Effect on vaginal health
In the vagina, Lactobacillus species positively affect vaginal health by maintaining a balanced microbiota and enhancing the re-establishment of a healthy vaginal environment after disturbances. Reinforcement of the vaginal microbiota helps prevent against vaginal discomfort (Larsson 2008; Larsson 2011; Pendharkar 2015).

Lactobacilli naturally regulate the environment by different modes of action. They inhibit growth of pathogens, which are always present in the vagina by:

  • Producing lactic acid which maintains a pH level between 3.8 and 4.2.
  • Maintaining this acidic environment is important, since pathogens grow poorly at a pH level below 4.5.
  • Forming H2O2, which has a natural antagonistic effect on pathogens.
  • Producing bacteriocins which inhibit growth of pathogens.
  • Producing biosurfactants, which cover the surface of the vaginal epithelium, thus inhibiting adhesion of pathogens.
  • Producing co-aggregation molecules which block the spread of pathogens.

Bacterial vaginosis
BV is characterized by a decrease in the quantity or composition of lactobacilli species and an increase in the number of anaerobic organisms (Lamont 2011). Two methods are commonly used to diagnose BV: the Amsel criteria and the Nugent score. The Amsel criteria consist of four points, of which three must be met to be diagnosed with BV. The criteria are:

  1. A thin, homogeneous vaginal discharge
  2. Vaginal pH higher than 4.5
  3. A “fishy” malodor of vaginal fluid before or after addition of 10% potassium hydroxide (KOH) (whiff test)
  4. Presence of clue cells on microscopic evaluation of a saline wet preparation

The other commonly used method to determine BV is the Nugent score. Here different bacterial morphotypes are quantified based on the gram staining technique, resulting in a score from 0 to 10. A score of 7-10 is considered as BV (Petrova 2015).

BV risk factors
There are many different factors influencing women’s risk of getting BV. Among the most common are:

  • Antibiotic treatment
  • Douching
  • Change in hormone level
  • Smoking

Antibiotic treatment is used to kill undesirable bacteria. Unfortunately, antibiotics also kill the protecting bacteria in the vagina such as lactobacilli. That often leads to recurrent BV. A study on antibiotic treated BV showed that the recurrence rate after 12 month was 52% (Bradshaw 2006; fig. 2)

Douching increases the risk of BV because it results in a disturbed vaginal microbiota (Brotman 2008). Women often start douching to avoid unpleasant odor. But when they douche, the lactobacilli that protect against adherence of anaerobe bacteria decrease.

Change in hormone levels - Every month, many women experience vaginal discomfort related to BV, which often results in the need for antibiotics. The vaginal microbiota changes naturally during the month, and bacteria that are leading to an increased risk of BV, increase at the end of the cycle (Srinivasan 2010).

Smoking is a factor that increases the risk of BV (Koullali 2016).

Consequences of an unbalanced microbiota
It is of high importance that BV is being treated and that the microbiota is being restored. BV is linked to a number of more severe conditions that can have a major impact on women. These include preterm delivery (Lamont 2011, Koullali 2016), higher risk of sexually transmitted diseases and infertility (Haahr 2016).

VVC is another condition that is caused by an unbalanced microbiota. Symptoms i.e. itching, burning, pain, redness of the vaginal mucosa and white discharge are common. VVC is often treated incorrectly, because women think, they have BV, and use non-prescription products. Predisposing factors for VVC include high estrogen oral contraceptive use, hormone replacement therapy, antibiotic usage, and underlying diabetes mellitus (Peters 2014).

Low self-esteem is the most common psychological consequence of BV. A survey among 500 adult American women showed that 29 % of women suffering from vaginal discomfort were depressed (Lipple, Taylor and Combe 2010).

Probiotics for recurrent BV
Recurrent BV is a major issue for women all over the world. A 6 month double-blind placebo-controlled study on the FemiBiotic strain combination has shown that the risk of BV recurrence can be lowered.These potent probiotics, designed for a woman’s health, act naturally with the body, making you feel healthy with no discomfort.

Route of transfer
After ingestion and surviving the acidic environment in the stomach, the probiotic bacteria are transported to the intestines, and finally reach the rectal part of the gastrointestinal tract. And from here, the bacteria are transported to the vagina, since the rectum is generally recognized as a significant reservoir for transfer of bacteria to the vagina (Bastani 2012). Studies have shown that several of the species found in the rectum can also be found in the vagina (Antonio 2005, El Aila 2009, Petricevic 2014).  The route of transfer is
visualized in fig. 4 below.



Capsule
An acid resistance capsule formulation ensures optimal protection of the probiotic strains in FemiBiotic™, and ensures optimal delivery to the intestines in women. The capsules disintegrate approximately 45 minutes later than typical immediate release capsules, which disintegrate after around 5 minutes.

Patented strain combination
The proprietary formulation used in our probiotics for women is patented and owned by Bifodan.

Lactobacillus rhamnosus PB01 DSM 14870 and Lactobacillus gasseri EB01 DSM 14869 show strong adherence to vaginal epithelial cells and produce high levels of lactic acid. Further, they each have unique properties:

  • Lactobacillus rhamnosus PB01: Is able to inhibit Gardnerella vaginalis, which is commonly associated with BV
  • Lactobacillus gasseri EB01: Has the ability to form H2O2


Both strains produce lactic acid and this may help maintaining the vaginal pH level between 3.8 and 4.2. Further, production of H2O2 helps inhibit pathogens.

In order to reach the intended site of effect, the bacteria have to survive the passage through the acidic environment in the stomach, and resist the disruptive effects of bile acids on bacterial cell surfaces. The bacterial strains used in our probiotics for women have both shown great capabilities of surviving at low pH levels, as well as being able to tolerate both bile and gastric acid, in addition to pancreatic juices (data on file).

When to use FemiBiotic™
FemiBiotic™, 1 capsule per day to:

  • Maintain and reinforce women’s intimate health
  • Maintain and protect a natural vaginal balance of lactobacilli, yeast and other natural occurring microorganisms in the vaginal microflora

Stability
Based on our extensive expertise within probiotic strain selection, product formulation, and manufacturing, FemiBiotic™ has been designed to have a shelf life of 24 months when stored at max. 77° F.



The expected level of bacteria at end of shelf life is based on a number of stability studies with the same strain combination and composition of excipients. Due to the similarities of excipients and usage of the same strain combination, the stability of FemiBiotic™ is not likely to differ from the stability studies used as references. Stability studies on FemiBiotic™ are commencing to confirm the expected stability.

 

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REFERENCES:
Al-Ghazzewi FH, Tester RF. Biotherapeutic agents and vaginal health. Journal of Applied Microbiology 2016: 121(1):18-27.

Antonio MAD, Rabe LK, Hillier SL. Colonization of the Rectum by Lactobacillus Species and Decreased Risk of Bacterial Vaginosis. Journal of Infectious Diseases 2005; 192(3):394-398.

Bastani P, Homayouni A, Tabrizian VG, Ziyadi. Dairy Probiotic Foods and Bacterial Vaginosis: A Review on Mechanism of action. In: Probiotics, Prof. E. Rigobelo (ed.), InTech; 2012: 445-456.

Bautista CT, Wurapa E, Sateren WB, Morris S, Hollingsworth B, Sanchez JL. Bacterial vaginosis: a synthesis of the literature on etiology, prevalence, risk factors, and relationship with chlamydia and gonorrhea infections. Military Medical Research 2016; 3:4.

Borges S, Silva J, Teixeira P. The role of lactobacilli and probiotics in maintaining vaginal health. Archives of Gynecology and Obstetrics 2014; 289(3): 479-489.

Bradshaw CS. High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence. Journal of Infectious Diseases 2006 Jun;
193(11):1478-1486.

Brotman RM, Klebanoff MA, Nansel TR, Andrews WW, Schwebke JR, Zhang J, Yu KF, Zenilman JM, Scharfstein DO. Longitudinal Study of Vaginal Douching and Bacterial Vaginosis-A Marginal Structural Modeling Analysis. American Journal of Epidemiology 2008; 168(2):188-196.

Haahr T, Jensen JS, Thomsen L, Duus L, Rygaard K, Humaidan P. Abnormal vaginal microbiota may be associated with poor reproductive outcomes: a prospective study in IVF patients. Human Reproduction 2016; 31(4):795-803.

Koullali B, Oudijk MA, Nijman TAJ, Mol BWJ, Pajkrt E. Risk assessment and management to prevent preterm birth. Seminars in Fetal & Neonatal Medicine 2016; 21(2): 80-88.

Lamont RF, Nhan-Chang C.-L., Sobel JD, Workowski K, Conde-Agudelo A, Romero R. Treatment of abnormal vaginal flora in early pregnancy with clindamycin for the prevention of spontaneous preterm birth: a systematic review and metaanalysis. American Journal of Obstetrics & Gynecology 2011; 205(3):177-190.

Larsson P.-G., Stray-Pedersen B, Ryttig KR, Larsen S. Human lactobacilli as supplementation of clindamycin to patients with bacterial vaginosis reduce the recurrence rate; a 6-month, double-blind, randomized, placebo-controlled study. BMC Womens Health 2008; 8:3.

Larsson P.-G., Brandsborg E, Forsum U, Pendharkar S, Andersen KK, Nasic S, Hammarström L, Marcotte H. Extended antimicrobial treatment of bacterial vaginosis combined with human lactobacilli to find the best treatment and minimize the risk of relapses. BMC Infectious Diseases 2011; 11:223.

Lipple, Taylor and Combe 2010. A survey conducted by Harris Interactive. Data on file.

El Aila NA, Tency I, Claeys G, Verstraelen H, Saerens B, Santiago GL dos Santos, de Backer E, Cools P, Temmerman M, Verhelst R, Vaneechoutte M. Identification and genotyping of bacteria from paired vaginal and rectal samples from pregnant women indicates similarity between vaginal and rectal microflora. BMC Infectious Diseases 2009; 9:167.

Pendharkar S, Brandsborg E, Hammarström L, Marcotte H, Larsson P.-G. Vaginal colonisation by probiotic lactobacilli and clinical outcome in women conventionally treated for bacterial vaginosis and yeast infection. BMC Infectious Diseases 2015; 15:255.

Peters BM, Yano J, Noverr MC, Fidel Jr PL. Candida vaginitis: When opportunism knocks, the host responds. PLoS Pathogens 2014; 10(4): e1003965.

Petricevic L, Kaufmann U, Domig KJ, Kraler M, Marschalek J, Kneifel W, Kiss H. Rectal Lactobacillus Species and Their Influence on the Vaginal Microflora: A Model of Male-to-Female Transsexual Women. Journal of Sexual Medicine 2014; 11(11):2738-2743.

Petrova MI, Lievens E, Malik S, Imholz N, Lebeer S. Lactobacillus species as biomarkers and agents that can promote various aspects of vaginal health. Frontiers in Physiology 2015; 6:81.

Sha BE, Chen HY, Wang QJ, Zariffard MR, Cohen MH, Spear GT. Utility of Amsel Criteria, Nugent Score, and Quantitative PCR for Gardnerella vaginalis, Mycoplasma hominis, and Lactobacillus spp. for Diagnosis of Bacterial Vaginosis in Human Immunodeficiency Virus- Infected Women. Journal of Clinical Microbiology 2005; 43(9):4607-4612.

Srinivasan S, Liu C, Mitchell CM, Fiedler TL, Thomas KK, Agnew KJ, Marrazzo JM, Fredricks DN. Temporal variability of human vaginal bacteria and relationship with bacterial vaginosis. PLoS ONE 2010;
5(4): e10197

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