A double blind, randomized, placebo-controlled study of SP-303 (Provir) in the symptomatic treatment of acute diarrhea among travelers to Jamaica and Mexico.

Abstract

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.

• Authors: Daniel DiCesare, Herbert L DuPont, John J Mathewson, David Ashley, Francisco Martinez-Sandoval, James E Pennington, Steven B Porter
• Journal: The American journal of gastroenterology (Am J Gastroenterol) Vol. 97 Issue 10 Pg. 2585-8 (Oct 2002) ISSN: 0002-9270 [Print] United States
• PMID: 12385443 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Biopolymers
• Catechin
• crofelemer

Topics

• Acute Disease
• Adult
• Biopolymers (therapeutic use)
• Catechin (analogs & derivatives, therapeutic use)
• Diarrhea (drug therapy)
• Double-Blind Method
• Female
• Humans
• Jamaica
• Male
• Mexico
• Travel