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did not change significantly during the
study. Promune maintains or increases weight in HIV-infected
patients with a history of wasting.
Two other, concurrent clinical trials were conducted using Promune
(Lucas D. Personal Communication, on file, Optim Nutrition, 1997).
The studies included 62 patients with AIDS and at least a 5-pound
weight loss during the past 6 months. Patients consumed 20 g
of whey protein (about 15 g of protein) in addition to their
normal diet for 8 weeks. Most patients gained weight: 59% in
one group (5.3 pounds) and 50% (9.7 pounds) in the other. The
addition of small amounts of whey (about 20% of protein needs)
facilitates weight gain in about one half of AIDS patients with
pre-existing weight loss.
Gastrointestinal Dysfunction
Gastrointestinal disease is common in HIV
infection, with from 60% to 100% of the patients getting it during
the course of illness.44 The chronic diarrhea from gastrointestinal
disease is associated with increased mortality and morbidity,
dehydration, poor quality of life, malnutrition, and increased
use of health care resources. About 50% of all gastrointestinal
disease can be related to a specific pathogen (i.e., parasites,
viruses, protozoa, fungi, mycobacteria, and enteric bacteria).
The remaining, undiagnosed cases remain problematic and frustrating
for patients and their clinicians. The cause of the undiagnosed
diarrhea may be occult pathogens or the HIV infection itself.
Adherent Bacteria
The clinical syndrome of diarrhea, wasting,
and a low CD4 cell count may be the result of adherent bacteria
whether the cause of the problem can be identified or not.45
Adherent bacteria have been identified in 17% of patients with
HIV infection, (11/66) but not seen in 12 normal controls or
in 10 patients with inflammatory bowel disease.46 Three distinct
patterns of adherence were observed: attaching and effacing lesions,
bacteria intercalated between microvilli, and aggregates of bacteria
more loosely attached to the damaged epithelium.
Adherence of bacteria to the epithelial
cells is a common trait of enteric bacteria, but it is not always
associated with clinical diarrhea.44 Chronic enteropathy and
perhaps HIV infection is associated with both structural and
functional changes in the enterocyte. These include increased
intestinal permeability and malabsorption; the barrier creat-
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ed by these cells to the outside environment
is damaged and the host is more vulnerable to outside pathogens.
The normal intestinal barrier is governed by both immunological
and non-immunological factors. The immunological factors are
primarily secretory immunoglobulins, specifically IgA. These
bind antigens in the intestinal lumen and prevent their adherence
to or penetration through the epithelial layer.5
Immunoglobulin A
The immunoglobulin IgA is lacking in saliva
and plasma cells of patients with AIDS, perhaps due to an IgA
secretory deficiency (Kotler DP, Personal Communication, on file,
Optim Nutrition, 1996). In order to avoid infections through
the intestine, the epithelium needs to be constantly bathed with
secretory immunoglobulins that are produced locally, found in
endogenous secretions, or supplied exogenously through colostrum
or specially processed whey.
Colostrum and specially processed whey
are rich sources of immunoglobulins, including IgA. Since a
newborn mammal can receive passive immunity from its mother,
the same is possible for an IgA-deficient patient from an enriched
source. In addition, the concentrated source of high-quality
protein serves to foster repair of the immune system and gastrointestinal
tract. Moreover, it is possible that the associated undesired
side effects of wasting, diarrheal disease, and a low CD4 cell
count may improve with use of whey enriched with immunoglobulins.
Cryptosporidia
The effect of specially processed whey
and colostrum have been studied extensively in patients with
HIV infection and AIDS who have cryptosporidium. This coccidia
is widespread in all phyla of vertebrates and common in patients
with HIV infections; 10% to 15% of such patients in the U.S.
have this organism, while in developing countries the estimate
is around 50%.47 Most organisms require both T and B lymphocytes
to be cleared, while cryptosporidia requires only B lymphocytes,
i.e., secretory IgA, IgM, IgG.48,49
Cow's colostrum and specially processed whey are postulated to
be efficacious against cryptosporidia. They are a rich source
of the immunoglobulins and antibodies to cryptosporidium that
have been identified in milk from cows infected with the organism.50
These antibodies can prevent the parasite from becoming attached
to the epithelium, thereby blocking its entry into the intestinal
mucosal. Products containing at least 1:120,000 hyperim-
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