Effect of bovine colostrum-based food supplement in the treatment of HIV-associated diarrhea in Northern Uganda: a randomized controlled trial.

AIM HIV-associated diarrhea is common in HIV/AIDS patients in developing countries. An earlier uncontrolled study showed that a nutritional product made from bovine colostrum (ColoPlus®) alleviates HIV-associated diarrhea. We performed a randomized single-blind controlled trial of addition of colostrum-based supplement (ColoPlus®) to standard anti-diarrhea treatment in HIV/AIDS patients with diarrhea. METHODS Eighty-seven adult patients with HIV-associated diarrhea were recruited at Gulu Hospital and four community clinics in Northern Uganda. Forty-five patients were randomized to receive 50 g of colostrum-based supplement twice a day for 4 weeks in addition to standard anti-diarrhea treatment, and 42 patients received standard anti-diarrhea treatment alone. Patients were followed up for 9 weeks. Daily stool frequency was recorded, and body weight and body mass index were evaluated at weeks 1, 4 and 9. Baseline CD4+ count was measured at baseline and at week 9. RESULTS Mean daily stool frequency decreased by 79% from 7.5 to 1.3 motions over the study period in patients on colostrum-based supplement, compared to a 58% reduction in controls (p < 0.001). Self-reported fatigue was reduced by 85% in patients on colostrum-based supplement by week 9 compared to 43% reduction amongst controls (p < 0.001). Patients on colostrum-based supplement had 11% increase (p < 0,001) in mean body weight and body mass index by week 9, but no changes were observed in control subjects. Mean CD4+ count increased by 14% for patients on colostrum-based supplement, in contrast to 12% decrease in controls (p < 0.001). CONCLUSIONS This study shows that addition of colostrum-based supplement to standard therapy is effective in treatment of HIV-associated diarrhea.