Short-Term Safety and Efficacy of Calcium Montmorillonite Clay (UPSN) in Children

Mitchell, Nicole; Kumi, Justice; Aleser, Mildred; Elmore, Sarah E.; Rychlik, Kristal A.; Zychowski, Katherine E.; Romoser, Amelia; Phillips, Timothy D.; Ankrah, Nii‐Ayi

doi:10.4269/ajtmh.14-0093

Cited by 27 publications

(18 citation statements)

References 60 publications

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“…This is comparable to the current study of SHINE women, in whom the mean urinary concentration of detectable samples was 270 pg/mL before adjustment for creatinine. Overall, the Zimbabwean levels are much higher than those reported from Brazil (range 0.19– 12.7 pg/mg creatinine) or Egypt (geometric mean 19.7 pg/mg creatinine) , but similar to those reported in two recent studies of adults and children in Ghana, and one study in children from Guinea, both considered a high‐risk countries .…”

Section: Discussionsupporting

confidence: 81%

Determinants of recent aflatoxin exposure among pregnant women in rural Zimbabwe

Smith

Mbuya

Prendergast

et al. 2017

Mol. Nutr. Food Res.

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Section: Discussionsupporting

confidence: 81%

Determinants of recent aflatoxin exposure among pregnant women in rural Zimbabwe

Smith

Mbuya

Prendergast

et al. 2017

Mol. Nutr. Food Res.

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“…This supports the findings from our similar clinical trial in Ghana (Wang et al 2008). Moreover, extensive clinical intervention trials in both animals and humans treated with a MED of calcium montmorillonite clays (HSCAS, NS, UPSN, ACCS100) have demonstrated significant AF biomarker reductions in serum and urine samples ranging from 33% to 78% in humans, or an average of 55.5% (Mitchell et al 2014, Mitchell et al 2013, Phillips et al 2008). Importantly, this reduction in metabolites and adducts of AF is consistent with other AF interventions and potential therapies (Groopman et al 2008).…”

Section: Discussionmentioning

confidence: 99%

Intervention trial with calcium montmorillonite clay in a south Texas population exposed to aflatoxin

Pollock

Elmore

Romoser

et al. 2016

Food Additives & Contaminants: Part A

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South Texas currently has the highest incidence of hepatocellular carcinoma (HCC) in the United States, a disease that disproportionately affects Latino populations in the region. Aflatoxin B1 (AFB1) is a potent liver carcinogen that has been shown to be present in a variety of foods in the U.S., including corn and corn products. Importantly, it is a dietary risk factor contributing to a higher incidence of HCC in populations frequently consuming AFB1-contaminated diets. In a randomized double-blind placebo controlled trial, we evaluated the effects of a three-month administration of ACCS100 (refined calcium montmorillonite clay) on serum AFB1-lysine adduct level and serum biochemistry in 234 healthy men and women residing in Bexar and Medina Counties, Texas. Participants recruited from 2012–2014 received either a Placebo, 1.5 g, or 3 g ACCS100 each day for three months, and no treatment during the 4th month. Adverse event rates were similar across treatment groups and no significant differences were observed for serum biochemistry and hematology parameters. Differences in levels of AFB1-lysine adduct at 1, 3, and 4 months were compared between Placebo and active treatment groups. Although serum AFB1-lysine adduct levels were decreased by month 3 for both treatment groups, the Low dose was the only treatment that was significant (p=0.0005). In conclusion, the observed effect in the Low dose treatment group suggests that the use of ACCS100 may be a viable strategy to reduce dietary AFB1 bioavailability during aflatoxin outbreaks and potentially in populations chronically exposed to this carcinogen.

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“…Calcium aluminosilicate exhibited potent C. difficile TcdA-and TcdB-neutralizing activity and selective protein binding in vitro. Given the well-documented safety profile of calcium aluminosilicate (34), these studies provide in vitro evidentiary support of our hypothesis that ingestion of calcium aluminosilicate might protect gastrointestinal tissues and accelerate a patient's recovery from antibiotic-or chemotherapy-induced C. difficile-associated diarrhea by neutralizing the cytotoxic effects of luminal TcdA and TcdB. Depending on its relative effectiveness and tolerability during downstream clinical studies, CAS UPSN M-1, the novel sequestration agent described in this study, may be used to complement or, possibly, replace existing antibiotic therapies for the treatment of CDI.…”

Section: Discussionmentioning

confidence: 99%

Effective Sequestration of Clostridium difficile Protein Toxins by Calcium Aluminosilicate

Sturino

Pokusaeva

Carpenter³

2015

Antimicrob Agents Chemother

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c Clostridium difficile is a leading cause of antibiotic-associated diarrhea and the etiologic agent responsible for C. difficile infection. Toxin A (TcdA) and toxin B (TcdB) are nearly indispensable virulence factors for Clostridium difficile pathogenesis. Given the toxin-centric mechanism by which C. difficile pathogenesis occurs, the selective sequestration with neutralization of TcdA and TcdB by nonantibiotic agents represents a novel mode of action to prevent or treat C. difficile-associated disease. In this preclinical study, we used quantitative enzyme immunoassays to determine the extent by which a novel drug, calcium aluminosilicate uniform particle size nonswelling M-1 (CAS UPSN M-1), is capable of sequestering TcdA and TcdB in vitro. The following major findings were derived from the present study. First, we show that CAS UPSN M-1 efficiently sequestered both TcdA and TcdB to undetectable levels. Second, we show that CAS UPSN M-1's affinity for TcdA is greater than its affinity for TcdB. Last, we show that CAS UPSN M-1 exhibited limited binding affinity for nontarget proteins. Taken together, these results suggest that ingestion of calcium aluminosilicate might protect gastrointestinal tissues from antibiotic-or chemotherapy-induced C. difficile infection by neutralizing the cytotoxic and proinflammatory effects of luminal TcdA and TcdB.C lostridium difficile is a leading cause of antibiotic-associated diarrhea (AAD) and is the etiologic agent responsible for C. difficile-associated infection (CDI). CDI typically starts as a mild diarrhea but rapidly degenerates into a variety of potentially lifethreatening conditions, including sepsis syndrome and pseudomembranous colitis (1). In the United States, approximately 330,000 cases of CDI are estimated to occur each year (2); however, the incidence of C. difficile infection continues to increase (2, 3). The increasing CDI rates highlight the fact that the current infection control procedures and treatment options are insufficient.In the health care setting, C. difficile endospores are transmitted to patients via the fecal-oral route (4). Following exposure, the host's gastrointestinal microbiota typically either quells a nascent C. difficile infection or suppresses it to subclinical levels (5). As a result of the latter, approximately 20% of hospitalized adults become asymptomatic C. difficile carriers, and the carriage rates approach 50% for patients in long-term care (6-9). The likelihood of development of CDI increases in patients with dysbiotic gastrointestinal microbiota, since C. difficile can thrive in the dysbiotic niche (5, 10). This dysbiosis is often the result of nonspecific chemotherapies that are used to treat conditions unrelated to C. difficile infection (e.g., antibacterial agents or antineoplastic drugs).The antibiotics metronidazole and vancomycin are currently used to treat CDI (11). Unfortunately, given the conflicting roles of antibiotics in the establishment and resolution of CDI, C. difficile AAD recurs in up to 1 in 5 patients (12)...

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Short-Term Safety and Efficacy of Calcium Montmorillonite Clay (UPSN) in Children

Cited by 27 publications

References 60 publications

Determinants of recent aflatoxin exposure among pregnant women in rural Zimbabwe

Determinants of recent aflatoxin exposure among pregnant women in rural Zimbabwe

Intervention trial with calcium montmorillonite clay in a south Texas population exposed to aflatoxin

Effective Sequestration of Clostridium difficile Protein Toxins by Calcium Aluminosilicate

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