Publications table of content
Discovery and characterization of the molecules
In many cultures, the application of the inner gel of Aloe vera barbadensis leaves for healing wounds and treating skin and mucosal infections has been documented. A collaboration between BioClin and the Free University University of Amsterdam revealed the promising anti-adhesive activity of the 2QR-complex. The 2QR-complex effectively blocks the adhesion of pathogenic microbes to human epithelial cells and tissues. The 2QR-complex is made up of large, negatively-charged polysaccharides obtained by molecular filtration and purification of the inner gel.1,2,3
The 2QR-complex and Antibiotics – A comparative study
A recent clinical study was performed in which the efficacy of metronidazole antibiotic treatment of bacterial vaginosis was compared with Multi-Gyn ActiGel (a 2QR-complex based product). Multi-Gyn ActiGel had comparable efficacy in reducing vaginal complaints.
The Study of First Line Treatment and Relief of Bacterial Vaginosis-related Vaginal Complaints with Metronidazole and Multi-Gyn ActiGel4
Metronidazole has been the treatment of choice prescribed for bacterial vaginosis (BV). Interfering with the bacterial adhesion mechanism may offer an alternative. Multi-Gyn ActiGel is a vaginal gel based on a high molecular polysaccharide complex that intervenes in microbial adhesion. During this open label study, 47 age-matched women with BV and related complaints received as first line treatment either a course of prescribed oral metronidazole or Multi-Gyn ActiGel intra-vaginally. Results: Oral metronidazole was slightly more effective at one week post treatment; Multi-Gyn ActiGel was equally as effective as metronidazole at three months post treatment. Conclusion: Physicians may encourage the use of this vaginal gel (Multi-Gyn ActiGel) for self-care in order to treat and relieve BV related symptoms and thus reduce the prescription of antibiotics and the emergence of resistance.
The following studies demonstrate the efficacy of 2QR-complex based gels to treat and prevent microbial health problems. BioClin’s Multi-Gyn ActiGel and Multi-Gyn LiquiGel are the products used in the studies.
• First line treatment and relief of bacterial vaginosis-related vaginal complaints with Metronidazole and
Multi-Gyn® ActiGel. European Obstetrics & Gynaecology 2012;7(2):103-6
• Pilot study on the efficacy of Multi-Gyn ActiGel to relieve discomforts related to vaginal infections in 50
women in Japanese gynecological clinics. 2013. Document on file.
• Gynecologists’ patient satisfaction survey: The efficacy of Multi-Gyn ActiGel to relieve discomforts related
to vaginal infectious complaints in 390 Italian women. 2012. Document on file.
• Patient satisfaction survey among 130 Polish women on the efficacy of Multi-Gyn ActiGel to relief complaints
related to vaginal dryness and vaginal infections. 2015. Document on file.
• Pilot study on the efficacy of Multi-Gyn FloraPlus to relieve signs and symptoms of vulvovaginal candidiasis
among 27 gynecological patients in Serbia. 2012. Document on file.
• Patient satisfaction survey among 58 Serbian women on the efficacy of Multi-Gyn LiquiGel to relieve
complaints related to vaginal dryness. 2016. Document on file.
• Pilot study to evaluate the efficacy of Multi-Gyn ActiGel in the treatment of nonspecific vulvitis and vaginitis
complaints among 50 women in The Netherlands. 1996. Document on file.
How microbial imbalance can lead to infection and inflammation
The disturbance of the healthy microbiota by intruding pathogens is known as dysbiosis. These pathogens start to compete with the beneficial bacteria by adhering to our epithelial tissues. Sites of entry in human hosts include the skin, the urogenital tract, the digestive tract, the respiratory tract and the eyes. Adherence of pathogenic microbes is the essential first step in the process of colonization and infection5,6.This results in an inflammatory response of our immune system to the pathogenic intruder, giving rise to symptoms such as redness, swelling, itching and/or a burning sensation.
General conclusions on Anti-adhesive Strategies
Adapted from Krachler et al 7
• Bacterial adherence to host tissues is a universally required early step for establishing infections and, thus, targeting this process holds promise as an alternative approach to conventional antibiotics for treating bacterial infections.
• Because anti-adhesive compounds clear rather than kill microbes, there is no selective pressure on the pathogen to develop resistance to this process, and development of resistance is highly unlikely.
• Several compounds show promise, but wider use of anti-adhesion therapy will depend on the discovery of new anti-adhesion drug targets and on compounds with better affinity, stability and bioavailability.
• Antibiotic-resistant strains of pathogens necessitate development of alternative means to prevent and treat bacterial infections.
A selection of publications about anti-adhesive therapy
• Kelly 2000, Expert opinion on investigational drugs. Anti-adhesive strategies in the prevention of infectious disease at mucosal surfaces8. Describes soluble mannose derivatives as effective agents to block FimH adhesin mediated binding of E. coli to bladder tissue.
• Sharon, 2006, Biochimica et biophysica acta. Carbohydrates as future anti-adhesion drugs for infectious diseases9. Clinical opportunities for anti-adhesive polysaccharides.
• Zopf, Lancet 1996, Oligosaccharide anti-infective agents. Describes oligosaccharides (large sugars) from human breast milk, mono- and polyvalent polysaccharides (both natural and biotechnologically developed therapeutics)10. The authors consider topical applications such as vaginal and nasopharyngeal as promising.
• Sharon 2000, Glycoconjugate journal. Safe as mother’s milk: carbohydrates as future anti-adhesion drugs for bacterial diseases11. Describes polysaccharides from mothers milk as safe potential future anti-adhesion drugs for bacterial diseases.
• Krachler 2013, Virulence. Targeting the bacteria-host interface: strategies in anti-adhesion therapy12. Natural mannose derivatives are well-known for their anti-adhesive effect. This paper describes new mannose-derived compounds were developed with enhanced FimH binding and improved systemic availability and stability.
1. Van Dijk W, Goedbloed AF, Koumans FJR. 2002. Negatively charged polysaccharide derivable from Aloe Vera. Publication Date:29.09.2004 Filing Date:23.12.2002. EP01205253. European patent office.
2. Van Dijk W, Bruyneel B, Van het Hof B, Nietfeld M, De Jong J, Celi P, Nijrolder I, Viegas C, Niessen H, Namavar F. 2004. A charged polymannose-containing fraction of Aloe vera gel inhibits binding of Helicobacter pylori to salivary mucin. Document on file. Amsterdam, The Netherlands.
3. Van Dijk W. 2006. Further characterization of negatively charged polysaccharides isolated from concentrated Aloe vera gel with regard to antibacterial properties and molecular structure. Document on file. Amsterdam, The Netherlands.
4. Bojovic T, Bojovic D, Tour FBD La, Lamers B. 2012. First Line Treatment and Relief of Bacterial Vaginosis-related Vaginal Complaints with Metronidazole and Multi-Gyn® ActiGel. Eur. Obstet. Gynaecol. 7: 107–110.
5. Finlay BB. 1997. Exploitation of Mammalian Host Cell Functions by Bacterial Pathogens. Science (80-. ). 276:718–725.
6. Ofek I, Hasty DL, Doyle RJ. 2003. Bacterial Adhesion to Animal Cells and Tissues. American Society for Microbiology Press, Washington, DC.
7. Krachler AM, Orth K. 2013. Made to Stick: Anti-Adhesion Therapy for Bacterial Infections. Microbe Mag. 8:286–290.
8. Kelly CG, Younson JS. 2000. Anti-adhesive strategies in the prevention of infectious disease at mucosal surfaces. Expert Opin. Investig. Drugs 9:1711–21.
9. Sharon N. 2006. Carbohydrates as future anti-adhesion drugs for infectious diseases. Biochim. Biophys. Acta 1760:527–37.
10. Zopf D, Roth S. 1996. Oligosaccharide anti-infective agents. Lancet 347:1017–21.
11. Sharon N, Ofek I. 2000. Safe as mother’s milk: carbohydrates as future anti-adhesion drugs for bacterial diseases. Glycoconj. J.
12. Krachler AM, Orth K. 2013. Targeting the bacteria-host interface: strategies in anti-adhesion therapy. Virulence 4:284–94.