e., Ascaris lumbricoides and Trichuris trichiura) was also determined and recorded for each participant individually. Each slide was examined Imatinib FDA independently in a blind manner by two microscopists. For quality control, several slides were re-examined by a senior staff. For confirmation of Fasciola and other helminth eggs, at baseline the merthiolate-iodine formaldehyde (MIF) concentration technique [26] was employed for one stool sample per participant. Briefly, 2.35 ml of stock MIF solution was added to at least about 0.5 g of each stool sample in a 15 ml centrifuge tube, closed with a rubber stopper, and placed in a refrigerator for subsequent examination. On the next morning 0.15 ml of Lugol’s iodine solution was added to each tube.
After centrifugation, the upper layers of sedimented feces containing parasite material were examined under a microscope. Laboratory investigations of blood included total leukocyte count, hemoglobin, eosinophilic count, alanine transpeptidase (ALT), aspartate transpeptidase (AST), alkaline phosphatase (ALP), gamma glutamyl transpeptidase (GGT), total serum bilirubin, blood urea, and serum creatinine. The blood specimens were collected into gel serum tubes (for clinical chemistry variables) and EDTA tubes (for hematology variables). Blood specimens collected into gel tubes were centrifuged at 1800�C2000 g for 10�C15 min. All blood specimens were analyzed on the day of collection. Statistical Analysis Data were entered using EpiData version 6.04 (Epidata Association; Odense, Denmark).
CR was calculated as proportion of individuals excreting Fasciola eggs before treatment and absence of eggs at study end. To determine infection intensity, the number of Fasciola eggs per Kato-Katz thick smear (41.7 mg of stool) was multiplied by a factor 24 to obtain eggs per gram of stool (EPG). Fecal egg counts (FECs) of multiple slides per individual were averaged, using the arithmetric mean. To calculate the reduction in infection intensity, individual egg counts were logarithmically transformed (log (count + 1) and the GM expressed as the antilogarithm of the mean. The ERR was calculated as [1 - GM FEC after treatment divided by GM FEC at admission multiplied by a factor 100]. Although infection intensity thresholds are currently lacking for infections with Fasciola [27], we classified infections into two groups: (i) light (1�C99 EPG) and (ii) moderate/heavy (��100 EPG).
Of note, a threshold of 100 EPG is also used to distringuish between light and moderate (100�C399 EPG) and heavy (��400 EPG) S. mansoni infection [27]. Fisher’s exact test, including 95% confidence Entinostat intervals (CI), and Mann-Whitney U test were used to compare the outcome of both studies (2-sided P values) assuming no difference in population or sensitivity of the parasite strain. The 2-tailed paired t-test and the Kruskal-Wallis tests were employed to compare the clinical parameters before and after treatment.