This is an interesting patent.  The inventor Carroll et al. believes that
botulism is the cause of SIDS.  Whether or not that hypothesis is true or not is
not as important as what is stated in this patent.  This patent is for
treatment of botulism and filed in 1997 with the assignee being Promega Corporation
(Wisconsin)  It seems to me after reading this patent that exclusive
breastfeeding might provide the sIgA that would provide the defense against infant
botulism creating less need for treatments and hospitalizations and infant deaths.
Valerie W. McClain, IBCLC

http://www.uspto.gov/patft/index.html
Patent # 6656468

Infectious infant botulism results from C. botulinum colonization of the
infant intestine with production of toxin and its absorption into the bloodstream.
It is likely that the bacterium gains entry when spores are ingested and
subsequently germinate. [S. Arnon, J. Infectious Diseases, 154:201-206 (1986).]
There have been 500 cases reported since it was first recognized in 1976. [M. N.
Swartz, supra.] Infant botulism strikes infants who are three weeks to eleven
months old (greater than 90% of the cases are infants less than six months).
[S. Arnon, J. Infectious Diseases, 154:201-206 (1986).] It is believed that
infants are susceptible, due, in large part, to the absence of the full adult
complement of intestinal microflora. The benign microflora present in the adult
intestine provide an acidic environment that is not favorable to colonization
by C. botulinum. Infants begin life with a sterile intestine which is
gradually colonized by microflora. Because of the limited microflora present in early
infancy, the intestine is not as acidic, allowing for C. botulinum spore
germination, growth, and toxin production. In this regard, some adults who have
undergone antibiotic therapy which alters intestinal microflora become more
susceptible to botulism.

An additional factor accounting for infant susceptibility to infectious
botulism is the immaturity of the infant immune system. The mature immune system is
sensitized to bacterial antigens and produces protective antibodies.
Secretory IgA produced in the adult intestine has the ability to agglutinate
vegetative cells of C. botulinum. [S. Arnon, J. Infectious Diseases, 154:201-206
(1986).] Secretory IgA may also act by preventing intestinal bacteria and their
products from crossing the cells of the intestine. [S. Arnon, Epidemiologic
Reviews, 3:45-66 (1981).] The infant immune system is not primed to do this.

Clinical symptoms of infant botulism range from mild paralysis, to moderate
and severe paralysis requiring hospitalization, to fulminant paralysis, leading
to sudden death. [S. Arnon et al., Epidemiologic Reviews, 3:45-66 (1981).]

The chief therapy for severe infant botulism is ventilatory assistance using
a mechanical respirator and concurrent elimination of toxin and bacteria using
cathartics, enemas, and gastric lavage. There were 68 hospitalizations in
California for infant botulism in a single year with a total cost of over $4
million for treatment. [T. L. Frankovich & S. Arnon, West. J. Med., 154:103
(1991).]




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