RESUMEN
BACKGROUND AND AIMS: In a previous uncontrolled experiment, oral vancomycin improved the symptoms (S) of chronic constipation (CC). The aim of this 21 day controlled pilot study was to determine if a low lincomycin dose improved the S of CC patients unresponsive to a high fiber diet. METHODS: On days 0-to-10, patients were randomized to 500 mg oral lincomycin + high fiber (L + F) or to placebo + high fiber (P + F). Participants and patients were blinded. From days 10-to-21, patients were continued solely on the high fiber diet. The primary efficacy endpoint was the difference in S between L + F and P + F from days 0-to-21 using a visual analog scale (VAS) calibrated from 0 = severe S to 10 = asymptomatic. RESULTS: The means of all S were significantly improved by L + F but not by P + F. A significant higher proportion of L + F patients increased the VAS > or = 3 points. CONCLUSIONS: The initial course of L facilitated the effect of F probably by its effect on the colon flora. This sequence of flora-altering biologics + F may serve as model to replace chronic use of drugs.