A phase I study of chemically synthesized verotoxin (Shiga-like toxin) Pk-trisaccharide receptors attached to chromosorb for preventing hemolytic-uremic syndrome.
A double-blind, placebo-controlled study was conducted to document possible side effects associated with oral consumption of synthetic verotoxin (VT, shiga-like toxin) Pk-trisaccharide receptor sequences attached to Chromosorb (Synsorb-Pk) by healthy adult volunteers. Synsorb-Pk reclaimed from volunteer stool samples was also analyzed to determine if its VT-binding activity was affected by exposure to the pH extremes and digestive processes of the human gastrointestinal tract. No participant reported any Synsorb-Pk-related adverse reactions, and no clinically important trends in laboratory data were evident. Synsorb-Pk recovered from stools retained its ability to absorb VT in polymyxin extracts of VT-producing Escherichia coli and also neutralized VT when mixed in vitro with VT-positive stools from children with hemorrhagic colitis or hemolytic-uremic syndrome (HUS). These results suggest a potential use for Synsorb-Pk in preventing HUS in patients infected with VT-producing E. coli.
Armstrong
G D
GD
Canadian Pediatric Kidney Disease Research Centre Synsorb-Pk Study Group, Ottawa.
Rowe
P C
PC
Goodyer
P
P
Orrbine
E
E
Klassen
T P
TP
Wells
G
G
MacKenzie
A
A
Lior
H
H
Blanchard
C
C
Auclair
F
F
D000042:Absorption; D000328:Adult; D001427:Bacterial Toxins / Q000378:metabolism; D002240:Carbohydrate Sequence; D002648:Child; D003092:Colitis / Q000378:metabolism; D007692:Diatomaceous Earth / Q000009:adverse effects* / Q000378:metabolism; D004311:Double-Blind Method; D005243:Feces / Q000737:chemistry; D006017:Glycolipids; D006463:Hemolytic-Uremic Syndrome / Q000378:metabolism / Q000517:prevention & control*; D006801:Humans; D008875:Middle Aged; D008969:Molecular Sequence Data; D011956:Receptors, Cell Surface; D022622:Shiga Toxin 1; D014312:Trisaccharides / Q000009:adverse effects* / Q000138:chemical synthesis / Q000378:metabolism
D001427:Bacterial Toxins; D006017:Glycolipids; D011956:Receptors, Cell Surface; D022622:Shiga Toxin 1; C068556:Shiga-like toxin receptor; D014312:Trisaccharides; D007692:Diatomaceous Earth