A double blind, randomized, placebo-controlled study of SP-303 (Provir) in the symptomatic treatment of acute diarrhea among travelers to Jamaica and Mexico.
OBJECTIVE
The study was designed to evaluate the effectiveness of SP-303 (Provir), a plant-derived product with novel antisecretory properties, in the treatment of travelers' diarrhea.


METHODS
A total of 184 persons from the United States who acquired diarrhea in Jamaica or Mexico were enrolled in a double-blind, placebo-controlled study examining the effectiveness of three doses of SP-303 in reducing illness. Subjects were treated with 125 mg, 250 mg, or 500 mg SP-303 or a matching placebo four times a day for 2 days. Subjects kept daily diaries of symptoms and were seen each day for 3 days. Of the subjects, 169 (92%) were included in the efficacy analysis.


RESULTS
The most common etiological agent identified was enterotoxigenic Escherichia coli, found in 19% of subjects. The mean time interval from taking the first dose of medication until passage of the last unformed stool during 48 h therapy (TLUS48) was 38.7 h for the placebo group. TLUS48 was shortened by SP-303: 30.6 h for the 125-mg dose group (p = 0.005); 30.3 h for the 250-mg group; and 32.6 h for the 500-mg group (p = 0.01). Treatment failures were seen in 29.3% in the placebo group compared with 7.3% (p = 0.01), 4.3 (p = 0.002), and 9.8 (p = 0.026) in the three treatment groups. SP-303 was well tolerated at all doses.


CONCLUSIONS
SP-303 was effective in shortening the duration of travelers' diarrhea by 21%. This antisecretory approach works directly against the pathophysiology of travelers' diarrhea and is not likely to potentiate invasive forms of diarrhea or to produce posttreatment constipation.
DiCesare
Daniel
D
The University of Texas-Houston School of Public Health, USA.
DuPont
Herbert L
HL
Mathewson
John J
JJ
Ashley
David
D
Martinez-Sandoval
Francisco
F
Pennington
James E
JE
Porter
Steven B
SB
D000208:Acute Disease; D000328:Adult; D001704:Biopolymers / Q000627:therapeutic use*; D002392:Catechin / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D003967:Diarrhea / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007563:Jamaica; D008297:Male; D008800:Mexico; D014195:Travel; D044945:Proanthocyanidins
D001704:Biopolymers; D002392:Catechin; C546704:crofelemer; D044945:Proanthocyanidins