Transcript Report - Coloplus AB

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)