Point-of-care circulating cathodic antigen positivity and associated factors in school children one year after mass praziquantel administration in an endemic district in Ghana.

Background: Mass drug administration of praziquantel is expected to reduce Schistosome carriage in treated children in endemic communities. However, the effectiveness of this annual exercise has not been assessed in Ghana. Therefore, this study aimed to detect viable Schistosoma mansoni infection using point-of-care circulating cathodic antigen (POC-CCA) positivity as proxy and associated factors in children previously treated with praziquantel in an endemic municipality in Ghana. Materials and methods: This cross-sectional study was done in the Assin Central municipality in the Central Region of Ghana. School children, less than 16 years of age, treated with 40 mg/kg of praziquantel (treatment period: February-March 2019), provided early morning urine (∼40 mL) and stool (∼4 g) samples. Immediately, POC-CCA (ICT International, South Africa) was done, while S. mansoni ova were detected in formalin fixed samples using microscopy later. Additionally, participant's socio-demographic information and factors associated with S, mansoni infection transmission were collected from each child. Results: A total of 520 children participated in the study (males-51.9%, majority age range [9-11 years, 34.4%]). Overall, 244 (46.9%) were positive for urinary CCA with no S. mansoni detected by microscopy. POC-CCA positivity was higher in females (48.4%), children with 2-3 siblings (49.3%), children aged 6-8-year range (55.4%) and residents of Brofoyedur (52%). However, age (x2 = 16.1, p = 0.0003) and town of residence (x2 = 11.7, p = 0.019) associated with CCA positivity. Further, location of water body (x2 = 16.4, p = 0.008), frequency of water contact (x2 = 12.3, p = 0.015) and handling of the Biomphalaria intermediate host (x2 = 5.1, p = 0.024) associated with POC-CCA outcome. Conclusion: About 47% of the school children were positive for CCA, one year after mass praziquantel administration in the Assin Central municipality. Varied factors associated with the post-praziquantel administration POC-CCA positivity. This study should be replicated in other endemic areas to identify groups at risk of parasite persistence or reinfection to inform modification of control and preventive measures.

Safety and Efficacy of Novasil Clay (Calcium Montmorillonite) in Children Exposed to Aflatoxin in Ejura-Sekyedumase District in Ghana.

Background. Aflatoxin levels are very high in animals and humans in places where cereals are poorly stored. In this study, Novasil was evaluated for safety and efficacy in children. Methods. Children (200) aged between 2 and 9 years were put into Novasil and placebo group. Participants received either 1.5 g of Novasil or calcium carbonate in their food. Urine samples were analyzed for AFM1 by HPLC, blood samples were assayed for complete blood count and chemistries. Results. Aflatoxin M1 levels in the Novasil treated group, significantly reduced to 60% compared to an increase of urine AFM1 in the placebo group. Hematological parameters did not change except for an increase in hemoglobin level in the Novasil group. Biochemical parameters remained unchanged except calcium ions. Glutathione levels in the Novasil increased, compared group to the placebo group. Conclusion. Novasil is safe, reduce aflatoxin bioavailability in humans while improving GSH antioxidant capacity as well. The trial has been registered with Pan African Clinical Trial Registry (www.pactr.org). A WHO registry for clinical trials with a unique identification number PACTR202202797930675.

Determination of aflatoxin levels in bokina beverage.

Objective: The main aim of this study was to investigate levels of total aflatoxin and aflatoxin M1 in bokina, a home-made non-alcoholic beverage prepared from dairy milk, millet and sugar. Methods: Bokina, dairy milk and millet were purchased monthly over a period of 7 months from bokina producers at Ashaiman and Nima, in Ghana. Total aflatoxin and aflatoxin M1 levels in these samples were measured using a fluorometric procedure and High-Performance Liquid Chromatography. Results: Aflatoxin levels in bokina samples ranged from 1.0 to 21.0 ppb for Ashaiman samples and 1.0 to 23.0 ppb for Nima samples. Out of 21 samples from each site 1 from Ashiaman and 2 from Nima had levels total aflatoxin above the acceptable limit of 20 ppb. Similarly, total aflatoxin levels millet samples ranged from 1.0 to 55.0 ppb for Ashaiman and 5.0 to 53.0 ppb for Nima samples, with 2 samples from Ashiaman and 6 from Nima having levels above 20ppb. The levels of Aflatoxin M1 in milk ranged from 0.09 to 6.20 ppb for Ashaiman samples and 0.13 to 12.55 ppb for Nima samples. Out of the samples, 12 from Ashiaman and 10 from Nima (n=21) had levels of Aflatoxin M1 above the acceptable limit of 0.5 ppb. Conclusion: Bokina samples tested were contaminated with aflatoxin. All doses of aflatoxin have a cumulative effect on the risk of cancer. Therefore, farmers and bokina producers must be educated on good storage practices and monitored to protect the public from aflatoxin exposure and toxicity. Funding: The study was self-funded.

Short-term safety and efficacy of calcium montmorillonite clay (UPSN) in children.

Recently, an association between childhood growth stunting and aflatoxin (AF) exposure has been identified. In Ghana, homemade nutritional supplements often consist of AF-prone commodities. In this study, children were enrolled in a clinical intervention trial to determine the safety and efficacy of Uniform Particle Size NovaSil (UPSN), a refined calcium montmorillonite known to be safe in adults. Participants ingested 0.75 or 1.5 g UPSN or 1.5 g calcium carbonate placebo per day for 14 days. Hematological and serum biochemistry parameters in the UPSN groups were not significantly different from the placebo-controlled group. Importantly, there were no adverse events attributable to UPSN treatment. A significant reduction in urinary metabolite (AFM1) was observed in the high-dose group compared with placebo. Results indicate that UPSN is safe for children at doses up to 1.5 g/day for a period of 2 weeks and can reduce exposure to AFs, resulting in increased quality and efficacy of contaminated foods.

Reduction in the urinary aflatoxin M1 biomarker as an early indicator of the efficacy of dietary interventions to reduce exposure to aflatoxins.

Aflatoxin B1 is a persistent public health issue in Ghana. Assessment of AFB1 intervention efficacy is currently dependent on long-term biomarkers. This study was designed to determine whether daily AFM1 biomarker levels could be utilized as an early detection method for intervention efficacy. Participants were treated with a refined calcium montmorillonite clay (UPSN) or a placebo (calcium carbonate) in a crossover study. Urine samples were assessed for AFM1 levels daily. UPSN treatment reduced AFM1 biomarkers by 55% compared to the placebo. This is the first study to show that daily urinary AFM1 levels can be used as a biomarker of internal aflatoxin B1 exposure in short-term intervention trials to determine efficacy.