LOW-DOSE OF POLYETHYLENE-GLYCOL-4000 - DI GESTIVE EFFECTS - RANDOMIZED DOUBLE-BLIND-STUDY IN HEALTHY-SUBJECTS

Objectives. - It was recently demonstrated that low-dose polyethylene glycol 4000 (PEG) electrolyte lavage solution, a colonic lavage soluti on used for cleaning the gut before colonic procedures, is effective i n the treatment of chronic constipation. The aim of our study was to d etermine the digestive effects of low-dose PEG 4000 without electrolyt e addition in healthy subjects. Methods. - Sixteen healthy male subjec ts with normal transit were included in a randomized controlled cross- over study. Study design included 4 successive periods: pre-inclusion (12 days), treatment (7 days), wash out (7 days), treatment (7 days). Colorectal transit time measurement and stool collection for physical and chemical investigations were performed during each period. During treatment period, either 20 g/d of PEG without electrolyte addition or placebo was given to each subject. Results. - With PEG, stool frequen cy increased significantly (1.26 +/- 0.09 with PEG versus 1.07 +/- 0.0 9 with placebo; P < 0.05) but no significant change in consistency was observed (P = 0.07). Total and segmental colonic transit time were co mparable with PEG and placebo. Mean stool weight increased from 74 g/d , by increase of stool water output (54 g/d) and dry stool weight (20 g/d). Increase of stool water output was not associated with improveme nt in stool hydration: stool water content was comparable with PEG (75 .4%) and with placebo (75.6%). No change was observed for the followin g parameters: stool electrolytes output, pH, organic acids, fecal outp ut of fat, alpha-1-antitrypsin clearance, presence of red and white bl ood cells. Fecal output of protein increased significantly from 3.2 +/ - 0.4 g/d to 6.0 +/- 0.7 g/d (P < 0.05). Conclusion. - No effect on co lonic transit and on stool hydration was observed with low dose of PEG 4000. With 20 g/d of PEG 4000, electrolytes addition is not necessary .