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Pharmax Clear Four 6 blisters of 90 capsules and 30 tablets

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Pharmax Candaclear Four- 6 blisters of 90 capsules and 30 tablets

Candaclear Four is a convenient way to provide the following groups of ingredients in four easy-to-take capsules and tablet. Each package contains 30 portable strips to enhance patient compliance.

Includes: Delayed release allicin Allicin with cinnamon Allicin with caprylates Probiotic providing 25 billion CFU with NAG, L-glutamine and beta-carotene

Probiotics included contain clinically proven strains

Human Lactic Commensals (HLC) probiotic strains are research-driven and clinically proven in randomized, double-blind, placebo-controlled human trials at 25 billion CFU per day. Proprietary non-pathogenic human-sourced microflora bacterial strains are utilized as they have strong epithelial adherence and a naturally high tolerance to stomach acid.

Additional product info: Total of 8 active ingredients combine to address intestinal dysbiosis* caused by yeast and protozoal parasites 1. Restrict dysbiosis* growth 2. Eliminate dysbiosis* in the small intestine and re-establish optimal microflora 3. Eliminate dysbiosis* in the large intestine 4. Restore intestinal mucosal integrity

Restrict dysbiosis* growth

Utilizing delayed release allicin

Why allicin? Allicin is a wide spectrum plant antimicrobial compound1 that has a minimal effect on the beneficial lactic acid flora of the gastrointestinal (G.I.) tract.2 The following is a visual example through electron micrographs demonstrating the effectiveness of Allicin, in vitro, on cells of E. Coli (effectiveness can be visually measured by the amount of dissipation of E. Coli). While the medicinal properties of fresh garlic have been known for centuries, the practical problem has been the ability to capture the active but volatile component allicin plus ensure its delivery to the entire intestinal tract.

Isolating allicin. Since allicin is formed instantaneously when crushing a garlic clove due to the interaction of an enzyme,3, 4 the allicin in Candaclear 4 incorporates the CYRO-dri process, freeze-drying without heat, to capture and create a concentrated version of the prime active allicin component.

Delayed release allicin in Candaclear Four. Allicin is rapidly absorbed from the small intestine with little being detected past the proximal ileum. Moreover, once absorbed, allicin is quickly converted by the liver into allyl sulphides which have significantly reduced bio activity. In addition, to exert any activity in the gut, they would need to pass back from the bloodstream into the intestinal lumen – a process which is at best uncertain. Providing allicin in a delayed release format ensures continuous release, over an 18 hour period as shown during in vitro studies. This delayed release helps to curb overall dysbiosis* growth.

Eliminate dysbiosis* in the small intestine

Utilizing allicin with cinnamon

Dysbiosis* generally effects both the small and large intestine, hence it is critical to ensure delivery of effective quantities of plant bioactives to both. Why cinnamon? Oil of cinnamon bark is carminative to the gastro-intestinal tract and possesses antiseptic properties.5, 6 Cinnamaldehydes (the major components of cinnamon bark oil) have the strongest antibacterial and antifungal activity of all of the common volatile oils.7, 8 The pre-emulsified, freeze-dried cinnamaldehyde powder concentrate is very gut active.9

Eliminate dysbiosis* in the large intestine

Utilizing allicin with caprylates

Why caprylic acid? When presented as calcium and magnesium salts, caprylic acid has antibacterial properties, by-passing the small intestine and splitting into into free caprylic acid and magnesium/calcium ions by the action of the microflora in the large intestine.10 Restore intestinal mucosal integrity and re-establish optimal microflora

Utilizing high potency probiotic with nutrients

Why L-Glutamine and N-Acetyl Glucosamine? The elimination of the dysbiosis* utilizing allicin, cinnamon and caprylates provides immediate stimulus to the regeneration of mucosal integrity. To augment this process, Candaclear Four contains both L-Glutamine, as the preferred energy source of mucosal cells of the small intestine,11 and N-Acetyl Glucosamine to provide the ‘glue’ which binds epithelial cells together and helps prevent ‘leakiness’ through the epithelial layer.12

Why high potency probiotics? An essential part of both the resolution of dysbiosis* and also the prevention of its recurrence is the provision of an effective and optimized microflora. These probiotic strains are research-driven and clinically proven in randomized, double-blind, placebo-controlled human trials at 25 billion CFU. 13, 14, 15, 16, 17 Our unique manufacturing process helps maintain high potency probiotic stability in combination with the complex nutrient blend. Manufacturing allows for ambient temperature (15-30ºC) storage and 2 year shelf-life without compromising product stability and still meet or exceed label claims.

Additional information The microbiota ensures intestinal structure, function and the homeostasis of the gut. Microbiota also maintains various functions which are vital to the maintenance of human health. In fact, disruption of the intestinal ecosystem equilibrium (gut dysbiosis) is associated with a plethora of human diseases, including autoimmune and allergic diseases, and bacterial infections (1). Candaclear Four is a moderate-level, long-term maintenance formula indicated for dysbiosis (2), and symptoms associated with irritable bowel syndrome (IBS) (3), which has also been shown in human double-blind, placebo-controlled clinical studies, at a core consortium of 25 billion CFU to: • Reduce the risk of Clostridium difficile associated diarrhea in hospitalized patients (4) • Significantly improved the Symptom Severity Score of patients suffering from irritable bowel syndrome (IBS) and scores for quality of life, days with pain and satisfaction with bowel habit compared to placebo, when taken for 8 weeks (5). Glutamine is an important fuel for rapidly dividing cells such as enterocytes and lymphocytes. Exogenous glutamine supplementation in catabolic states preserves intestinal mucosal structure and function, decreases bacterial translocation, and supports normal immunologic responses (6). L-Glutamine at 5 grams daily support digestive system health after periods of physical stress (7).

Remodelling of the extracellular matrix is an inevitable consequence of inflammation. The central role of fibroblasts in determining the outcome of either tissue restoration or scarring is now recognized to be of central importance. In both Crohn's disease and ulcerative colitis there is particularly widespread breakdown of sulphated glycosaminoglycans (GAGs), related to the infiltration of activated macrophages. N-acetyl glucosamine (Glc-NAc or NAG) constitutes a metabolic fuel for fibroblast and epithelial GAG synthesis which may potentially augment tissue repair mechanisms. This naturally occurring amino sugar, which is derived from crab shell chitin, is both inexpensive and without known toxic effects. It is avidly taken up in vitro, in preference even to glucosamine, by inflammatory bowel disease tissue. In addition to its role in the biosynthesis of GAGs, it may potentially augment epithelial defences by contributing to mucin biosynthesis. In addition, there is intriguing recent evidence showing that GlcNAc also acts intracellularly as an antagonist of O-phosphorylation and may thus regulate many inflammatory pathways. Garlic is traditionally used in Herbal Medicine to help relieve the symptoms associated with upper respiratory tract infections and catarrhal conditions (8). In a randomised study, 210 patients who were HP positive in biopsy were assigned to seven treatment groups (each group consisting of 30 patients). Group I was given standard eradication treatment (lansaprasol 30 mg bid, clarithromycin 500 mg bid, amoxicillin 1 g bid for 14 days). Group II received AA 1000 mg/day in addition to the standard treatment. Group III received only AA 1000 mg/day for 14 days. Group IV was treated with standard regiment plus 120 mg/day BC. Group V was given only BC 120 mg/day for 14 days. Group VI was given standard regiment and allicin 4200 micrograms/day. Group VII received only Allicin 1200 micrograms/day for 14 days. The eradication was achieved in 20 (66.6%) in Group I, 15 (50%) in Group II, 3 (10%) in Group III, 15 (50%) in Group IV, 0 (0%) in Group V, 27 (90%) in Group VI and 7 (23.3%) in Group VII. Allicin seemed to be a potentially effective agent for HP eradication but ascorbic acid and beta caroten were found to be ineffective (9). Cinnamomum verum J. S. Presl, corticis aetheroleum (cinnamon bark oil) is a Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro- intestinal complaints including bloating and flatulence (10).

References: 1 Prakash S, Rodes L, Coussa-Charley M, Tomaro-Duchesneau C. Gut microbiota: next frontier in understanding human health and development of biotherapeutics. Biologics. 2011;5:71-86. 2 Prakash S, Rodes L, Coussa-Charley M, Tomaro-Duchesneau C. Gut microbiota: next frontier in understanding human health and development of biotherapeutics. Biologics. 2011;5:71-86. 3 Williams EA, Stimpson J, Wang D, Plummer S, Garaiova I, Barker ME, Corfe BM. “Clinical trial: a multistrain probiotic preparation significantly reduces the symptoms of irritable bowel syndrome in a double-blind placebo-controlled trial.” Alimentary Pharmacology & Therapeutics. 2008. 29(1):97-103. 4 Plummer, S., Weaver, M.A., Harris, J.C., Dee, P. and Hunter, J. “ Clostridium difficile pilot study: effects of probiotics supplementation on the incidence of C.difficile diarrhea.” International Microbiology. 2004; 7(1):59-62. 5 Williams EA, Stimpson J, Wang D, Plummer S, Garaiova I, Barker ME, Corfe BM. “Clinical trial: a multistrain probiotic preparation significantly reduces the symptoms of irritable bowel syndrome in a double-blind placebo-controlled trial.” Alimentary Pharmacology & Therapeutics. 2008. 29(1):97-103. 6 Yalçin SS, Yurdakök K, Tezcan I, Oner L. Effect of glutamine supplementation on diarrhea, interleukin-8 and secretory immunoglobulin A in children with acute diarrhea. J Pediatr Gastroenterol Nutr. 2004 May;38(5):494-501. 7 NHPD Monograph on L-Glutamine. 2008. 8 NHPD Monograph on Garlic. May 2008. 9 Koçkar C, Oztürk M, Bavbek N. Helicobacter pylori eradication with beta carotene, ascorbic acid and allicin. Acta Medica (Hradec Kralove). 2001;44(3):97-100. Abstract 10 European Medicine Agency (EMEA) monograph for cinnamon’s bark oil. http://www.ema.europa.eu/docs/en_GB/document_library/Herbal_-_Community_... 1. Ankri S, Mirelman D. Antimicrobial properties of allicin from garlic. Microbes Infect. 1999 Feb;1(2):125-9. Review. PubMed PMID: 10594976. 2. Rees, LP, Minney, SF, Plummer, NT, Slater, JH & Skyrme, DA. A quantitative assessment of the antimicrobial activity of garlic (Allium sativum). World Journal of Microbiol & Biotech 1993 3. Ankri 125-9. 4. Rees 1993. 5. Ellingwood F. The American Materia Medica, Therapeutic and pharmacognosy, 1919. [internet] [Accessed November 16, 2011]. Available at: http://www.swsbm. com/Ellingwoods/Ellingwoods_plants_only.pdf 6. BPC. The British Pharmaceutical Codex 1911. Internet] [Accessed November 29, 2011]. Available at: http://www.henriettesherbal.com/eclectic/bpc1911/ cinnamomum-zeyl_oleu.html 7. Singh HB, et al, Cinnamon bark oil, a potent fungitoxicant against fungi causing respiratory tract mycoses. Allergy. 1995;50:995–999. 8. Yousef RT, Towil GG. Antimicrobial activity of volatile oils. Pharmazie 1980;35(11):698-701. 9. Yousef 698-701. 10. Nair MK, Joy J, Vasudevan P, et al. Antibacterial effect of caprylic acid and monocaprylin on major bacterial mastitis pathogens. J Dairy Sci 2005;88:3488-95 11. Ekrem KAYA, Alper CEYLAN, Nurten KARA, Hakan GÜVEN, Levent YILDIZ The effect of L-glutamine on mucosal healing in experimental colitis is superior to short-chain fatty acids. Department of Surgery, Uluda¤ University, School of Medicine, Bursa. Departments of Surgery, 3Molecular Biology and 4Pathology, Ondokuz May›s University, School of Medicine, Samsun. Turk J Gastroenterol 2007; 18 (2): 89-94 12. http://www.crohns.net/Miva/education/articles/N_acetyl_Glucosamine.shtml 13. Allen S.J. et al. Dietary supplementation with lactobacilli and bifidobacteria is well tolerated and not associated with adverse events during late pregnancy and early infancy. J Nutr 2010; 140: 483-488. 14. Williams EA, et al. Clinical trial: a multistrain probiotic preparation significantly reduces symptoms of irritable bowel syndrome in a double-blind placebo-controlled study. 2009; 29(1): 97-103. 15. Plummer S, et al. Clostridium difficile pilot study: effects of probiotic supplementation on the incidence of C. difficile diarrhoea. Int Microbiol. 2004;7(1):59-62. 16. Plummer SF, et al. Effects of probiotics on the composition of the intestinal microbiota following antibiotic therapy. Int J Antimicrob Agents. 2005; 26(1); 69-74. 17. Madden JA, et al. Effect of probiotics on preventing disruption of the intestinal microflora following antibiotic therapy: a double-blind, placebo-controlled pilot study. Int Immunopharmacol. 2005; (6): 1091

Other ingredients: 1. Delayed release allicin Hypromellose, dicalcium phosphate, cellulose, vegetable magnesium stearate, silica, glycerin, titanium dioxide 2. Allicin with cinnamon Hypromellose, vegetable magnesium stearate, silica 3. Allicin with caprylates Hypromellose, vegetable magnesium stearate, silica 4. Probiotic with nutrients Hypromellose, vegetable magnesium stearate, silica




Nutritional Information (Click image for Detailed View)