MANAGEMENT OF HIV IN CHILDREN USING A BOVINE COLOSTRUM-BASED FOOD SUPPLEMENT Odong, Patrick Olwedo, Amuru District Local Government, Uganda; Angwech, P J, Gulu Women Economic Development and Globalisation, Uganda; Kuule, J and Obol, J, Faculty of Medicine, Gulu University, Uganda Introduction Malnutrition increases severity and mortality of HIV infection. HIV and malnutrition tend to occur in the same population, the underprivileged and resourcepoor. Uganda has striven to fight the Human Immunodeficiency Virus (HIV) epidemic with a multi-sectoral approach which led to a drop in the prevalence rates from 18% in the early 1990’s to national seroprevalence of 6.4 %, although the prevalence has again risen to 7.3%. COLOSTRUM Colostrum is the first milk the lactating cow gives to the calf during its first days of life. It is a very rich source of fat, protein, sugar and micronutrients. Bovine colostrum has also very high levels of several bioactive components such as antimicrobial peptides (e.g. lactoferrin) and immunoglobulins (IgG, IgM, IgA) active against a wide range of bacterial, viral and protozoa pathogens as well as against various bacterial toxins. A biological function of colostrum is to, through its composition, provide the calf with passive immunity until its own immune system is fully functional, and thereby prevent infections such as diarrhea. Another function is to counteract malnutrition and support growth of the calf through its high levels of nutrients and growth factors. ColoPlus ColoPlus is a bovine colostrum-based food product consisting of two components, one bioactive part(bovine colostrum) and one food product vehicle. The vehicle is composed of food product particulate matter, which is used to slow down and control time required to empty the stomach, thus prolonging intestinal exposure to the colostrum. ColoPlus comes as a dry powder and has to be mixed with lukewarm water to obtain a porridge suitable for consumption. ColoPlus Nutrional facts per 100 g Major bioactive components per 100 g Energy (kJ/kcal) Proteins (g) Fat (g) Carbohydrates (g) Lactose (g) Dietary fibers (g) 1650/350 23 2 69 6 1,8 IgG (g) 7,4 IgA (g) 1,1 Lactoferrin (g) 0,5 Lactoperoxidase (g) 0,2 Proline-rich polypeptides (g) 1,5 IGF 1 (µg) 100 IGF 2 (µg) 7,2 TGF alfa (µg) 0,8 TGF beta (mg) 8,3 Studies in Nigeria and Uganda In previous clinical studies in Nigeria (Florén et al. Scand J Gastroenterol 2006; 41: 682-686) and Uganda (Kaducu et al. Indian J. of Gastroenterol 2011; 30: 270-276) ColoPlus was given to adult HIV-patients for four weeks. In both studies there was a significant increase of body weight, improvement of nutritional and immunological status, improved quality of life, reduced fatigue and normalized stool frequency. In none of the studies were any side effects of ColoPlus observed. Aim of the Study The aim of this field program/study was to provide a major cohort of HIV-infected children with the colostrum-based food product ColoPlus and at the same time investigate the effect of ColoPlus on their nutritional status and immunological capacity. Another aim was to study the tolerability and safety of the product when given to children. Methods In a major field program 850 malnourished HIV-positive children 8 months to 18 years old were given 50 g of ColoPlus daily for 4 weeks as the first meal in the morning. The program was carried through in selected health facilities in the districts of Gulu. Amuru and Nwoya in Northern Uganda. Fortynine of the children (21 female and 28 male, 8 months to 14 years of age, mean 6,4 years) were recruited into a descriptive prospective study and followed-up for 12 weeks. At the start (week 0) and at weeks 4, 8 and 12 body weight, fatigue (VA scale), CD4+, serum albumin and hemoglobin were analyzed and statistical calculations were applied using Student's t-test. The remaining 801 patients were enrolled under observation. They were monitored through interviews and focus group discussions to observe and register effects, tolerability and safety of ColoPlus. The interviews were structured in two ways: on one hand as one-toone interviews with children 8 years and older and on the other hand as interviews with parents to children under 8 years. In this group of 801 children ColoPlus effects were expressed as estimates and no quantifiable data on a structured basis were obtained. Child before and after eating ColoPlus for 4 weeks Results (1) The 49 children prospectively followed increased their immunological capacity measured as CD4+ counts at 4 weeks by 15,4% (± 2,8%) p = 0.0001 at 8 weeks by 39,1% (± 3,9%) p = < 0.0001 at 12 weeks by 2,1% (± 2,8%) NS Results (2) The corresponding figures for hemoglobin and serumalbumin were: at 4 weeks: 6.7% ↑ (p=0.0001) and 7,4% ↑ (p<0.0001), respectively at 8 weeks: 12,0% ↑ (p<0.0001) and 12.0% ↑ (p<0.0001), respectively at 12 weeks: 5,2% ↑ (p=0.02) and 5,2% ↑ (p=0.02), respectively Results (3) In all 49 children there was a significant increase in average body weight and a decreased fatigue. Results (4) ColoPlus was well tolerated by all the 850 children and no side effects were seen. No adverse events were observed. Conclusion The results show that addition of a colostrum-based therapeutic food product to the daily diet is beneficial in HIV-positive malnourished children. An improvement in nutritional status as well as in immune capacity was obvious. These effects remained 4 to 8 weeks after cessation of ColoPlus administration. Discussion Our results indicate that the colostrum-based supplement ColoPlus is effective in reducing selfestimated fatigue levels, thereby improving a sense of patient well-being and functionality in HIV+ children. The study participants who received ColoPlus, achieved weight gain and had increased haemoglobin, serum albumin and increased CD4+ cell counts. These findings are consistent with those seen in the previous studies using ColoPlus on adult patients. Acknowledgement • • • • • ColoPlus AB, Malmö Sweden, Sweden IKEA Foundation Swedish Embassy, Kampala, Uganda Ministry of Health, Uganda Gulu Women Economic Development and Globalisation, Uganda • The Districts of Amuru, Gulu and Nwoya-Northern Uganda • Research Team • The participants (Community)