This prospective randomized clinical trial at a tertiary referral hospital in southern India was undertaken to determine whether
amylase resistant starch, substituting for
glucose in hypo-osmolar
oral rehydration solution, would reduce
diarrhea duration and weight in adults with acute severe dehydrating
diarrhea. 50 adult males with severe watery
diarrhea of less than three days' duration and moderate to severe
dehydration were randomized to receive hypo-osmolar
ORS (HO-
ORS) or HO-
ORS in which
amylase resistant high
amylose maize
starch 50g/L substituted for
glucose (HAMS-
ORS). All remaining
therapy followed standard protocol. Duration of
diarrhea (
ORS commencement to first formed stool) in hours was significantly shorter with HAMS-
ORS (median 19, IQR 10-28) compared to HO-
ORS (median 42, IQR 24-50) (Bonferroni adjusted P, P(adj)<0.001). Survival analysis (Kaplan-Meier) showed faster recovery from
diarrhea in the HAMS-
ORS group (P<0.001, log rank test). Total
diarrhea fecal weight in grams (median, IQR) was not significantly lower in the HAMS-
ORS group (2190, 1160-5635) compared to HO-
ORS (5210, 2095-12190) (P(adj) = 0.08). However, stool weight at 13-24 hours (280, 0-965 vs. 1360, 405-2985) and 25-48 hours (0, 0-360 vs. 1080, 55-3485) were significantly lower in HAMS-
ORS compared to HO-
ORS group (P(adj) = 0.048 and P = 0.012, respectively).
ORS intake after first 24 hours was lower in the HAMS-
ORS group. Subgroup analysis of patients with culture isolates of Vibrio cholerae indicated similar significant differences between the treatment groups.
CONCLUSIONS: Current Controlled Trials ISRCTN72841333.