Efficacy of partially hydrolyzed guar gum (PHGG) supplemented modified oral rehydration solution in the treatment of severely malnourished children with watery diarrhoea: a randomised double-blind controlled trial.

OBJECTIVES: To examine whether PHGG added ORS reduce duration of diarrhoea, stool output and enhance weight gain. METHODS: In a double-blind controlled clinical trial, 126 malnourished children (weight for length/weight for age < -3 Z-score with or without pedal edema), aged 6 - 36 months with acute diarrhoea <7 days were studied in two treatment groups; 63 received modified WHO ORS (Na 75, K 40, Cl 87, citrate 7, glucose 90 mmol/L) with PHGG 15 g/L (study group); 63 received modified WHO ORS without PHGG (control). Other treatments were similar in both groups. The study protocol was approved by Ethics Committee of icddr,b; the study was carried out at the Dhaka Hospital. RESULTS: The mean duration of diarrhoea (h) was significantly shorter in children of the study group (Study vs. control, mean ± SD, 57 ± 31 vs. 75 ± 39, p = 0.01). Although there was a trend in stool weight reduction in children receiving ORS with PHGG (study vs. control, stool weight (g), mean ± SD; 1(st) 24 hour, 854.03 ± 532.15 vs. 949.11 ± 544.33, p = 0.32; 2(nd) 24 hour, 579.84 ± 466.01 vs. 761.26 ± 631.64, p = 0.069; 3(rd) 24 hour, 385.87 ± 454.09 vs. 495.73 ± 487.61, p = 0.196), especially in 2(nd) 24 h period, the difference was not statistically significant. The mean time (day) to attain weight for length 80% of NCHS median without edema was significantly shorter in the study group (study vs. control, mean ± SD, 4.5 ± 2.6 vs. 5.7 ± 2.8, p = 0.027). CONCLUSION: PHGG added to ORS substantially reduced duration of diarrhoea. It also enhanced weight gain. Further studies might substantiate to establish its beneficial effect. CLINICAL TRIAL REGISTRATION NUMBER: NCT01821586.

Salovum egg yolk containing antisecretory factor as an adjunct therapy in severe cholera in adult males: a pilot study.

Cholera involves stimulation of intestinal secretory process in response to cholera toxin leading to profuse watery diarrhoea that might cause death due to dehydration unless timely rehydration therapy is initiated. Efforts to identify and test potential antisecretory agents are ongoing. Antisecretory factor (AF) is a naturally-occurring protein produced in the human secretory organs, including the intestine, with antisectory properties demonstrated in animal and human models of secretory diarrhoea. Salovum egg yolk powder contains antisecretory proteins in a much higher (500 times) concentration than that of normal hen eggs. This is achieved by feeding hens with specially-processed cereals, capable of inducing antisecretory proteins in the yolk. The aim of the study was to examine the effect of Salovum egg yolk powder containing AF in the treatment of adult cholera patients. In an open, randomized controlled trial (pilot study), 40 adult male patients with severe cholera were studied: 20 received standard treatment (oral rehydration solution, antibiotic, and usual hospital diet) plus Salovum egg yolk powder (study group) and 20 received standard treatment alone (control group). All the patients received tablet doxycycline (300 mg) once immediately after randomization. Written informed consent was obtained from each subject before enrollment. The main outcome measures were stool weight and duration of diarrhoea. The demographic and baseline clinical characteristics of the study patients were comparable between the groups. No significant differences were found in the mean stool weight, g/kg of body-weight during the first 24 hours [study vs control group, mean +/- standard deviation (SD), 218 +/- 119 vs 195 +/- 136], second 24 hours (mean +/- SD, 23 +/- 39 vs 22 +/- 34), and cumulative up to 72 hours (mean +/- SD, 245 +/- 152 vs 218 +/- 169). The duration (hours) of diarrhoea after admission in the hospital was also similar in both the groups (mean +/- SD, 33 +/- 14 vs 32 +/- 10). No adverse effect was observed. Salovum egg powder containing AF as an adjunct therapy in the treatment of severe cholera could not demonstrate any beneficial effect. Further studies with higher doses of Salovum egg yolk powder might be considered in future to establish its antisecretory effect.