Lactose vaginal tablets prevent transmission of HIV

Bacterial vaginosis (BV) is a very common adverse female condition characterized by vaginal discharge with an unpleasant smell. Clinically, it is generally considered just a nuisance, but there is evidence of very serious side effects including premature labour¹¹, and increased susceptibility toward viral infections⁸.

Several clinical investigations have shown that BV is an important risk factor for the transmission of HIV infection in a challenged environment. Cohen et al.(2012) have proven that infected women are more likely to transfer the infection to their male partners. Several studies have shown that having BV makes infection with HIV more likely for women³. Moreover, the mechanism involved in transferring HIV has been shown to be strongly influenced by the vaginal microbiota ^{5, 7, 10, 13}.

Most convincing is the work done by Hilber et al., 2010, a metastudy showing a strong relationship between BV and acquisition of HIV.

Bacterial vaginosis is a very common condition (up to 50% of African women). It is characterized as a condition, where the normal lactic acid bacteria are replaced by anaerobic bacteria (Gardnerella, Mobiluncus and others) and the pH is elevated above the pH of 4.5 considered healthy.

The root cause for development of BV is not known. As the condition is characterized with an outgrowth of unwanted Gardnerella or lack of Lactobacillus, the classical treatment is either antibiotics/ disinfectants to eliminate the Gardnerella, or administration of lactic acid bacteria to supplement the microbiota.

LadyBalance is based on the assumption that BV is caused by a physiological condition depleting the indigenous lactic acid bacteria of their supply of nutrient. The correction is therefore supply of an acceptable nutrient. General microbiological knowledge shows, that lactose is the optimal nutrient: Can be assimilated by good lactic acid bacteria; cannot be assimilated by the most relevant pathogenic organisms. The clinical evidence is based on feedback from European women having purchased the lactose tablet. For those having purchased the tablet to eliminate the symptoms of BV, 90% reported positive effects. There were no serious side effects².

Product and company

The product was invented by a microbiologist and registration in many countries is ongoing. Information can be found on www.ladybalance.dk.

The product is a vaginal tablet made from lactose monohydrate, which is stable for years (at present tested up to 8 years) at ambient temperature, reasonably dry. There are no strong capital interests behind the company.

Even the lactose tablet is active against discharge; it supplies vaginal humidity and lubrication. This fact might not be appreciated by all users in Africa – contrary to users in other parts of the world.

Trial

In case an organization is involved in health care / monitoring of HIV in areas, where frequency of new HIV positive individuals is a relevant parameter, LadyBalance would like to supply trial products. It is a requirement that the effect of the lactose vaginal tablet as regards prevention of HIV virus spread can be monitored.

1)    Cohen CR, Lingappa JR, Baeten JM, Ngayo MO, Spiegel CA, Hong T, Donnell D, Celum C, Kapiga S, Delany S, Bukusi EA (2012) : PLoS Med. 2012 Jun;9(6):e1001251. Epub 2012 Jun 26: Bacterial vaginosis associated with increased risk of female-to-male HIV-1 transmission: a prospective cohort analysis among African couples.

2)    Emery SJ^,, Tomlinson M J, Hansen I D (2012) Sex Transm Infect 2012;88:A27 doi:10.1136/sextrans-2012-050601c.51 : P51 Patient-reported effects of vaginal lactose as a prebiotic for bacterial vaginosis. http://sti.bmj.com/content/88/Suppl_1/A27.1

3)    Guédou FA, Van Damme L, Mirembe F, Solomon S, Becker M, Deese J, Crucitti T, Alary M. (2012) Sex Transm Infect. 2012 May 24. [Epub ahead of print].Intermediate vaginal flora is associated with HIV prevalence as strongly as bacterial vaginosis in a cross-sectional study of participants screened for a randomised controlled trial.

4)    Hilber AM, Francis SC, Chersich M, Scott P, Redmond S, Bender N, Miotti P, Temmerman M, Low N. (2010) PLoS One. 2010 Feb 9;5(2):e9119. Review. Intravaginal practices, vaginal infections and HIV acquisition: systematic review and meta-analysis.

5)    Levinson P, Choi RY, Cole AL, Hirbod T, Rhedin S, Payne B, Guthrie BL, Bosire R, Cole AM, Farquhar C, Broliden K. (2012) PLoS One. 2012;7(2):e31996. Epub 2012 Feb 28 HIV-neutralizing activity of cationic polypeptides in cervicovaginal secretions of women in HIV-serodiscordant relationships.

6)    Low N, Chersich MF, Schmidlin K, Egger M, Francis SC, van de Wijgert JH, Hayes RJ, Baeten JM, Brown J, Delany-Moretlwe S, Kaul R, McGrath N, Morrison C, Myer L, Temmerman M, van der Straten A, Watson-Jones D, Zwahlen M, Hilber AM. (2011) PLoS Med. 2011 Feb 15;8(2):e1000416. Review. Intravaginal practices, bacterial vaginosis, and HIV infection in women: individual participant data meta-analysis.

7)    Monachese M, Cunningham-Rundles S, Diaz MA, Guerrant R, Hummelen R, Kemperman R, Kerac M, Kort R, Merenstein D, Panigrahi P, Ramakrishna B, Safdar N, Shane A, Trois L, Reid G. (2011) Gut Microbes. 2011 May-Jun;2(3):198-207. Epub 2011 May 1: Probiotics and prebiotics to combat enteric infections and HIV in the developing world: a consensus report.

8)    Rodriguez-Cerdeira C, Sanchez-Blanco E, Alba A. (2012) ISRN Obstet Gynecol. 2012;2012:240190. Epub 2012 Jul 31. Evaluation of Association between Vaginal Infections and High-Risk Human Papillomavirus Types in Female Sex Workers in Spain.

9)    Schellenberg JJ, Plummer FA (2012) Int J Inflam. 2012;2012:131243. Epub 2012 Mar 14.The Microbiological Context of HIV Resistance: Vaginal Microbiota and Mucosal Inflammation at the Viral Point of Entry.

10)  Schellenberg JJ, Card CM, Ball TB, Mungai JN, Irungu E, Kimani J, Jaoko W, Wachihi C, Fowke KR, Plummer FA (2012) AIDS. 2012 Jan 28;26(3):387-93. Bacterial vaginosis, HIV serostatus and T-cell subset distribution in a cohort of East African commercial sex workers: retrospective analysis.

11)  Swadpanich U, Lumbiganon P, Prasertcharoensook W, Laopaiboon M.(2008) Cochrane Database Syst Rev. 2008 Apr 16;(2):CD006178. Review Antenatal lower genital tract infection screening and treatment programs for preventing preterm delivery.

12)  Thurman AR, Doncel GF. (2011) Am J Reprod Immunol. 2011 Feb;65(2):89-98. doi: 10.1111/j.1600-0897.2010.00902.x. Review Innate immunity and inflammatory response to Trichomonas vaginalis and bacterial vaginosis: relationship to HIV acquisition.

13)  Watts DH. (2012) J Acquir Immune Defic Syndr. 2012 Jul 1;60(3):221-4.Mother to child transmission of HIV--another complication of bacterial vaginosis?