BackgroundThere is no published information about the use of different protocols to administer a highly diluted medication.Evaluate the effect of different protocols for treatment with biotherapic T. cruzi 17 dH (BIOTTc17dH) on clinical/parasitological evolution of mice infected with T. cruzi-Y strain.MethodsA blind, randomized controlled trial was performed twice, using 60 28-day-old male Swiss mice infected with T. cruzi-Y strain, in five treatment groups: CI - treated with a 7% ethanol-water solution, diluted in water (10 μL/mL) ad libitum; BIOTPI - treated with BIOTTc17dH in water (10 μL/mL) ad libitum during a period that started on the day of infection; BIOT4DI - treated with BIOTTc17dH in water (10 μL/mL) ad libitum beginning on the 4th day of infection; BIOT4-5–6 - treated with BIOTTc17dH by gavage (0.2 mL/ animal/day) on the 4th, 5th and 6th days after infection; BIOT7-8–9 - treated with BIOTTc17dH by gavage (0.2 mL/ animal/day) on the 7th, 8th and 9th days after infection. We evaluated: parasitemia; total parasitemia (Ptotal); maximum peak of parasites; prepatent period (PPP) - time from infection to detection of the parasite in blood; patent period (PP) - period when the parasitemia can be detected in blood; clinical aspects; and mortality.ResultsParasitological parameters in the BIOTPI and mainly in the BIOT4PI group showed better evolution of the infection compared to the control group (CI), with lower Ptotal, lower maximum peak of parasites, higher PPP, lower PP and longer survival times. These animals showed stable body temperature and higher weight gain and water consumption, with more animals having normal-appearing fur for longer periods. In contrast, groups BIOT4-5–6 and BIOT7-8–9 showed worse evolution of the infection compared to the control group, considering both parasitological and clinical parameters. The correlation analysis combined with the other data from this study indicated that the prepatent period is the best parameter to evaluate the effect of a medication in this model.ConclusionsThe BIOT4DI group showed the best clinical and parasitological evolution, with lower parasitemia and a trend toward lower mortality and a longer survival period. The prepatent period was the best parameter to evaluate the effect of a medication in this model.