Efficacy of a combination of nucleotides and lactoferrin in maintaining stable or improving the clinical picture and laboratory findings of leishmaniotic dogs: A randomized controlled study

: This prospective, randomized, controlled, therapeutic study aimed to evaluate the efficacy of a product containing nucleotides and lactoferrin in maintaining or improving the clinical picture and laboratory findings of canine leishmaniosis (CanL). The safety and tolerance of this combination were also assessed. Forty Leishmania infantum-seropositive dogs, not requiring leishmanicidal and/or leishmaniostatic treatment, were enrolled in the study and randomized into treatment (TG) and placebo (CG) groups. Products A (containing nucleotides and lactoferrin) and B (placebo) were blindly administered to TG and CG, respectively, as palatable tablets at a rate of 1 tablet per 10 kg of weight once every 24 h for 6 months. Following inclusion (T0), dogs were followed up after 3 (T90) and 6 (T180) months. At each time point, for all animals enrolled physical examination and laboratory tests (complete blood count, biochemical panel including C-reactive protein [CRP] and ferritin, and serum protein electrophoresis) were performed. The immunofluorescence antibody test to detect antibodies for L. infantum (T0, T180), Ehrlichia canis (T0, T90, and T180), and Anaplasma phagocytophilum (T0, T90, and T180) was executed. A CanL-dedicated clinical score, using a validated scale from 0 (i.e., absence of clinical signs) to 19, was assigned. Four dogs (n=2 in TG, n=2 in CG) did not complete the study. No statistically significant differences in CanL clinical score were observed between CG and TG at T0, T90 and T180. Both TG and CG showed significant variations in anti-L. infantum antibody titres (p=0.0001 and p=0.004, respectively). In TG, antibody titres decreased in 77.8 %, increased in 5.5 %, and remained stable in 16.7 % of dogs, while in CG, decreased in 27.8 %, increased in 50 %, and remained stable in 22.2 % of dogs. During the study, CRP and ferritin remained stable in TG and significantly increased in CG. At T180, 9 out of 18 dogs (50 %) enrolled in the CG, and 1 out of 18 (5.6 %) enrolled in the TG, developed an active form of leishmaniosis. No side effects were reported in any patient included. In conclusion, a 6-month oral administration of a supplement containing nucleotides and lactoferrin was effective in maintaining a stable clinical score, improving antibody titres and potentially reducing the progression from non-active to active forms in L. infatum seropositive dogs. Furthermore, the product was well-tolerated, easy to administer, and free of side effects.