Selective antimicrobial modulation of the intestinal flora of patients with acute nonlymphocytic leukemia: a double-blind, placebo-controlled study.

Thirty-three patients with acute nonlymphocytic leukemia were studied during remission-induction treatment in a double-blind, placebo-controlled, randomized study to ascertain the effect on the incidence of infection of an oral regimen of selective antimicrobial modulation (SAM). A decrease in the number of major acquired infections was observed: three infections occurred in 16 patients receiving the SAM regimen compared with eight infections in 17 patients given the placebo. The reduction of infection was correlated with a reduction of fever, with a reduction of the frequency of administration of antimicrobial agents for the treatment of infection, and with the selective elimination of aerobic and facultative anaerobic gram-negative rods from the digestive tract. Substantial unfavorable side effects were not observed.

RCT Entities:   Population Interventions Outcomes