Infectious Diarrhoea

Rotavirus infection The clinical evidence available suggests hyperimmune BC is a promising agent in the prophylaxis and treatment of infectious diarrhoea caused by rotavirus. One Australian study using BC containing high titres of antibody to all four human rotavirus serotypes found that administration successfully prevented symptomatic infection in 100% of children treated with the preparation (Davidson et al 1989). It also reduced the duration of rotavirus excretion, which may have implications for preventing cross-infection. A double-blind study of 75 boys aged 6-24 months with rotavirus diarrhoea compared ordinary BC to hyperimmune BC (100 ml_ three times daily for 3 days) from cows immunised with four serotypes of human rotavirus (Mitra et al 1995). Diarrhoea ceased within 48 hours in 50% of children receiving hyperimmune BC whereas 100% of children receiving ordinary BC continued to have diarrhoea. Total stool output (g/kg) between admission and cessation of diarrhoea was also reduced in the group receiving hyperimmune BC compared with ordinary BC. Another double-blind study also found that treatment with anti-rotavirus immunoglobulin of BC origin is effective in the management of children with acute rotavirus diarrhoea (Sarker et al 1998). A double-blind study of children aged 6-30 months found treatment with hyperimmune BC (100 ml_ solution four times daily for 4 days) lead to improved weight gain, decreased duration of diarrhoea and resulted in fewer stools, although the differences were not statistically significant compared to ordinary colostrum or placebo (Ylitalo et al 1998).

Studies using hyperimmune BC in young children have identified rotavirus antibodies as early as 8 hours after ingestion and up to 72 hours after consumption Colostrum 318

has ceased, with a strong relation between the titre of rotavirus antibody adminis-

tered and the level of antibody activity detected in the faeces (Pacyna et al 2001). This suggests that passive immunity is imparted to the entire length of the gastrointestinal tract.

Shigella infection According to one small study, hyperimmune BC with a high titre of ant\-Shigella flexneri 2a lipopolysaccharide prevented the incidence of shigella infection in 10 of 10 volunteers whereas 5 of 11 volunteers administered a control substance went on to develop the infection (Tacket et al 1992). HIV-induced diarrhoea BC has also been investigated as a potential treatment in HIV-induced diarrhoea, a symptom that occurs in most patients infected with AIDS. A BC product (Lactobin, Biotest, Dreieich, Germany) containing high titres of antibodies against a wide range of bacterial, viral and protozoal pathogens, as well as against various bacterial toxins, was tested in a multicentre pilot study involving 29 HIV-infected patients (Rump et al 1992). An oral dose of 10 g/day produced a transient (10 days) or long-lasting (>4 weeks) normalisation of the stool frequency in 21 patients. Mean daily stool frequency decreased from 7.4 to 2.2 at the end of the treatment. Some success was also obtained 1 year later in a prospective, open, uncontrolled study of 25 HIV patients with chronic refractory diarrhoea and either confirmed cryptosporidiosis (n = 7) or absence of demonstrable pathogenic organisms (n = 18) (Plettenberg et al 1993). An oral dose of 10 g/day of an immunoglobulin preparation from BC over a period of 10 days led to complete remission of cryptosporidiosis infection in 3 of 7 subjects and 2 had partial remission. Complete remission was also seen in 7 of 18 patients with diarrhoea and negative stool culture and a further 4 had partial remission. Of those subjects not responding to treatment, doubling of the dose to 20 g/day led to partial remission in four more patients and complete remission in one.

A BC product designed for slow passage through the gastrointestinal tract (ColoPlus) was tested over 4 weeks in an open-label study of 30 people with HIV-associated diarrhoea (Floren et al 2006). Treatment resulted in a dramatic decrease in daily stool evacuations (from 7.0 ± 2.7 to 1.3 ± 0.5), a mean increase of 7.3 kg of body weight, a 125% increase in CD4+ count and a substantial decrease in self-estimated fatigue.

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