Hypotonic oral rehydration solution in acute diarrhoea: a controlled clinical trial

In a controlled trial, a hypotonic oral rehydration solution (ORS) (Na⁺67, K⁺20, CP66, citrate 7, glucose 89mmol/1 osmolality 249 mosmol/kg) was compared with a standard WHO-ORS (Na⁺90, K⁺20, Cl^-80, citrate 10, glucose lllmmol/1, osmolality 311 mosmol/kg) in 60 children aged 5-24 months with acute watery diarrhoea. In the hypotonic ORS group, stool frequency, proportion of children who vomited, ORS requirements and purging rate over 24-48 h were reduced by 33% ( p = 0.01), 30% ( p = 0.02), 21% ( p = 0.067) and 21% ( p = 0.03), respectively. The proportion of children who vomited and the purging rate over 48 h were reduced by 23% ( p = 0.03) and 10% ( p = 0.097), respectively. Serum electrolytes after 48 h were comparable. The beneficial effect of hypotonic ORS was most marked in, and largely contributed by, the subgroup negative for rotavirus.     

Evaluation of oral hypo-osmolar glucose-based and rice-based oral rehydration solutions in the treatment of cholera in children

In a randomized controlled clinical trial, the efficacy of a low-sodium low-glucose oral rehydration solution (ORS) and a low-sodium rice-based ORS was compared with standard WHO glucose ORS in the treatment of severe cholera in children aged 2-10y. In total, 120 children were evaluated for the study, of whom 58 patients were positive for Vibrio cholerae and were included in the study. Of these 58 cases, 19 received rice-based hypo-osmolar ORS, 20 received WHO-ORS and 19 received glucose-based hypo-osmolar ORS. The clinical characteristics (age, preadmission duration of diarrhoea, frequency of stool before admission, incidence of vomiting, body weight and volume of initial fluid requirement) were comparable in the three treatment groups. All patients received tetracycline in a dose of 50 mg/kg/d of body weight in 4 divided doses for 3 d. CONCLUSIONS: Patients who received rice-based hypo-osmolar ORS had subsequently reduced (p < 0.05) stool output, ORS consumption and diarrhoea duration than the patients who received either WHO-ORS or glucose-based hypo-osmolar ORS.     

A trial in the Karelian Republic of oral rehydration and Lactobacillus GG for treatment of acute diarrhoea

In a controlled trial in Petrozavodsk, Karelia, the effects of oral rehydration and Lactobacillus strain GG (LGG) on recovery from acute diarrhoea (27% rotavirus, 21% bacterial aetiology) were studied in 123 children aged between 1 and 36 months of age. On admission to hospital, the patients were first randomized to receive either isotonic oral rehydration solution (ORS) with osmolality 311mosmol/l and sodium 90mmol/l (WHO-ORS), or a hypotonic ORS with osmolality 224mosmol/l and sodium 60mmol/l (Light-ORS), and thereafter randomized to receive either 5 × 10⁹ colony forming units of LGG or a matching placebo. The two ORS performed equally for acute rehydration, and oral rehydration with either ORS was associated with a shorter duration of diarrhoea than intravenous rehydration ( p = 0.036). Patients receiving LGG had a significantly shorter duration of watery diarrhoea [mean (SD) 2.7 (2.2) days] than those receiving the placebo [3.7 (2.8) days, p = 0.03]. LGG significantly shortened the duration of rotavirus diarrhoea but not diarrhoea with confirmed bacterial aetiology.     

Hypo-osmolar oral rehydration salts solution in dehydrating persistent diarrhoea in children: double-blind, randomized, controlled clinical trial

A double-blind, randomized, controlled trial was conducted to compare the clinical efficacy of hypo-osmolar oral rehydration salts (ORS) solution (224 mmol/L) and standard ORS solution (311 mmol/L) in children with persistent diarrhoea who were prone to develop dehydration. Initially, 95 children aged between 3 and 24 mo were included in the study for overnight observation. Of these, 70 children who passed stool more than 2 g/kg/h were finally enrolled in the study and were randomly assigned either standard ORS or hypo-osmolar ORS. After decoding the identity of ORS, it was observed that 37 children were in the standard ORS group and 33 in the hypo-osmolar ORS group. Clinical parameters and microbiological findings of stool samples were comparable in the two groups at the time of enrolment. Total stool output (2.5 ± 1.1 vs 3.2 ± 1.6 kg; p = 0.04), duration of diarrhoea (114.8 ± 38.3 vs 145.4 ± 40.0 h; p = 0.002), total intake of ORS (5.4 ± 1.6 vs 7.8 ± 1.8 l; p = 0.002) and total fluid intake (7.9 ± 2.6 vs 10.0 ± 4.1 l, p = 0.01) were significantly less in the hypo-osmolar ORS group compared to the standard ORS group. However, the percentage of weight gain on recovery in the hypo-osmolar group was less compared to that of the standard ORS group, though the difference was statistically insignificant. Thirty-five (95%) children in the standard ORS and 33 (100%) children in the hypo-osmolar group recovered within 10 d of initiation of therapy and modified dietary management. Conclusion: Our findings suggest that hypo-osmolar ORS has beneficial effects on the clinical course of dehydrating persistent diarrhoea.     

Clinical experience with a hypotonic oral rehydration solution in acute diarrhoea

A hypotonic oral rehydration salts (ORS) solution with total osmolality of 224 rnosmol/l was compared in an open clinical trial with an isotonic (osmolality 304 mosmol/l) ORS solution for the treatment of dehydration due to acute diarrhoea. Both ORS solutions had the same electrolyte composition with a Na⁺ concentration of 60 mmol/l. Children given the hypotonic ORS solution ( n = 103) passed significantly fewer diarrhoeal stools, and their diarrhoea and hospital stay were shorter than those of children given the isotonic ORS solution ( n= 135). We conclude that hypotonic ORS ("light" ORS) has clinical advantages over the standard ORS currently used in Finland.     

Hypo-osmolar sucrose oral rehydration solutions in acute diarrhoea: a pilot study

Based on studies showing improved absorption of hypo-osmolar oral rehydration solutions (ORS) with reduced glucose and sodium concentration, a hypo-osmolar ORS with sucrose replacing glucose (sodium 60, potassium 15, chloride 60, citrate 5, sucrose 58mmoll^?1, calculated osmolality 198mOsmkg^?1) was compared with mildly hyperosmolar glucose ORS (WHO) in 46 children aged 6–30 months with acute diarrhoea and dehydration. In the hypo-osmolar sucrose ORS group (n = 18) faecal output was less by 30% during the initial 24 and 48 h compared with controls, suggesting better absorption. Sucrose may be a suitable alternative to glucose in an absorption-efficient hypo-osmolar ORS.     

Randomised double blind study of hypotonic oral rehydration solution in diarrhoea

A hypotonic (osmolality 224 mmol/l, sodium 60 mmol/l) oral rehydration solution (ORS) was compared with an isotonic high glucose ORS (osmolality 304 mmol/l, sodium 60 mmol/l) in children with acute diarrhoea in a randomised double blind study. The stool output and hence the mean consumption of ORS for maintenance hydration was less (p = 0.036) in patients receiving hypotonic (69 ml/kg) than isotonic (97 ml/kg) ORS. Hypotonic ORS was more effective in patients with rotavirus positive than with rotavirus negative diarrhoea.     

Alanine-based oral rehydration solution: assessment of efficacy in acute noncholera diarrhea among children

This randomized, double-blind trial determined whether adding 90 mmol/L of alanine with a reduction in glucose to 90 mmol/L (alanine ORS) improves the efficacy of the standard oral rehydration solution (WHO-ORS). One hundred twenty-nine males aged 3-48 months with weight for length greater than or equal to 70% of NCHS, diarrheal duration less than or equal to 96 h, and clinical signs of mild to moderate dehydration were randomly allocated to either treatment group. During 0-6 h of treatment, ORS was offered at 120 ml/kg for rehydration without food or water. Beyond 6 h, ORS was offered as a volume-to-volume replacement for stool losses and a mixed diet of uniform composition was offered in amounts standardized for body weight. The most frequently isolated pathogens in alanine ORS and WHO-ORS groups were rotavirus (42 and 48%, respectively) and enterotoxigenic Escherichia coli (15 and 12%, respectively). In the 0-6 h period when food was withheld, median urine output in ml/kg (8;5, p less than 0.05) and percentage decrease in total serum solids (9:7%, p = 0.06) was significantly greater in alanine ORS than in WHO-ORS; median ORS intake and stool output were marginally lower in the alanine group but the differences were statistically not significant. Between 0 h and recovery, although the median values for duration of diarrhea (56.5 and 65.0 h), ORS consumption (260 and 323 ml/kg), and stool output (188.4 and 216.3 g/kg) were lower in the alanine ORS group, these differences with the WHO-ORS group were not statistically significant.(ABSTRACT TRUNCATED AT 250 WORDS)     

Randomised double blind study of hypotonic oral rehydration solution in diarrhoea

Accepted 19 November 1996
A hypotonic (osmolality 224 mmol/l, sodium 60 mmol/l) oral rehydration solution (ORS) was compared with an isotonic high glucose ORS (osmolality 304 mmol/l, sodium 60 mmol/l) in children with acute diarrhoea in a randomised double blind study. The stool output and hence the mean consumption of ORS for maintenance hydration was less (p = 0.036) in patients receiving hypotonic (69 ml/kg) than isotonic (97 ml/kg) ORS. Hypotonic ORS was more effective in patients with rotavirus positive than with rotavirus negative diarrhoea.

     

Are human milk long-chain polyunsaturated fatty acids related to visual and neural development in breast-fed term infants?

OBJECTIVE: We evaluated and compared the efficacy of the World Health Organization (WHO) oral rehydration solution (ORS) and 2 different formulations of reduced osmolarity ORSs in infants with persistent diarrhea. STUDY DESIGN: Infants with persistent diarrhea (n = 95) were randomized to 1 of the 3 ORSs: WHO-ORS (control, n = 32), a glucose-based reduced osmolarity ORS (RORS-G, n = 30), or a rice-based reduced osmolarity ORS (RORS-R, n = 31) for replacement of ongoing stool losses for up to 7 days. Major outcome measures were stool volume and frequency, ORS intake, and resolution of diarrhea. RESULTS: Although there were variations from one study day to another, the stool volume was approximately 40% less in the reduced osmolarity ORS groups; consequently, these children required less ORS (22% for RORS-G and 27% for RORS-R groups). A higher proportion of children in the RORS-R groups also had resolution of diarrhea during the study period. No children in any of the treatment groups had hyponatremia. CONCLUSION: Reduced osmolarity ORS is clinically more effective than WHO-ORS and may thus be advantageous for use in the treatment of children with persistent diarrhea.     

Double blind, randomised controlled clinical trial of hypo-osmolar oral rehydration salt solution in dehydrating acute diarrhoea in severely malnourished (marasmic) children.

AIMS: To compare the clinical efficacy of hypo-osmolar oral rehydration salt (ORS) solution (224 mmol/l) and standard ORS solution (311 mmol/l) in severely malnourished (marasmic) children having less than 60% Harvard standard weight for age with dehydrating acute watery diarrhoea. METHODS: In a double blind, randomised, controlled trial, 64 children aged 6-48 months were randomly assigned standard (n = 32) or hypo-osmolar ORS (n = 32). RESULTS: Stool output (52.3 v 96.6 g/kg/day), duration of diarrhoea (41.5 v 66.4 hours), intake of ORS (111.5 v 168.9 ml/kg/day), and fluid intake (214.6 v 278.3 ml/kg/day) were significantly less in the hypo-osmolar group than in the standard ORS group. Percentage of weight gain on recovery in the hypo-osmolar group was also significantly less (4.3 v 5.4% of admission weight) than in the standard ORS group. A total of 29 (91%) children in the standard ORS group and 32 (100%) children in the hypo-osmolar group recovered within five days of initiation of therapy. Mean serum sodium and potassium concentrations on recovery were within the normal range in both groups. CONCLUSION: Our findings suggest that hypo-osmolar ORS has beneficial effects on the clinical course of dehydrating acute watery diarrhoea in severely malnourished (marasmic) children. Furthermore, children did not become hyponatraemic after receiving hypo-osmolar ORS.     

Impact of zinc supplementation in malnourished children with acute watery diarrhoea

A double-blind, randomized, controlled clinical trial was conducted on 80 malnourished children with acute dehydrating diarrhoea to evaluate the efficacy of oral supplementation of zinc as an adjunct therapy to oral rehydration solution (ORS). After decoding it was observed that 44 children received zinc sulphate (177 mg/kg/day in three divided doses equivalent to 40 mg elemental zinc) in a syrup form and 36 children received only syrup placebo. Clinical parameters and microbiological findings of stool samples were comparable in the two groups at the time of enrollment. All the children (100 per cent) in the zinc supplemented group and 32 (89 per cent) children in the placebo group recovered within 5 days of hospitalization (p = 0.04). The zinc supplemented group had a significantly shorter duration of diarrhoea (70.4 +/- 10.0 vs. 103.4 +/- 17.1 h; p = 0.0001), passed less liquid stool (1.5 +/- 0.7 vs. 2.4 +/- 0.7kg; p=0.0001), consumed less oral rehydration solution (2.5 +/- 1.0 vs. 3.6 +/- 0.8 litre; p = 0.0001) and other liquids (867.0 +/- 466.1 vs. 1354.7 +/- 675.6 ml; p = 0.0001) as compared to the placebo group. Our findings suggest that zinc supplementation as an adjunct therapy to ORS has beneficial effects on the clinical course of dehydrating acute diarrhoea.     

Comparison of efficacy of a glucose/glycine/glycylglycine electrolyte solution versus the standard WHO/ORS in diarrheic dehydrated children

It was hypothesized that a mixture of glucose and amino acids enhances sodium and water absorption and therefore diminishes the volume of oral rehydration solution, stool output, and duration of diarrhea. To investigate this hypothesis, the efficacies of two oral rehydration solutions (ORS) were compared, one containing (mmol/L): Na+ 90, K+ 20, Cl- 80, citrate 10, glucose 67, glycine 53, and glycylglycine 30, yielding an osmolality of 350 mosmol/kg H2O, and the other, the standard ORS recommended by the World Health Organization, containing the same electrolyte concentrations and only glucose 110 mmol/L, yielding 310 mosmol/kg H2O. The study group comprised 31 infants and small children for group A (receiving solution A, the glucose/glycine/glycylglycine-based ORS) and 31 patients for group B (receiving solution B, the standard WHO/ORS). There were no significant differences between the groups in age, fluid loss, or dehydration, or between the groups with respect to clinical outcome, mean time to achieve rehydration, mean percent body weight gain, and serum electrolyte composition. The only statistically significant difference was the mean time between admission and the last diarrheic stool. The glycylglycine/glycine/glucose electrolyte solution was found to be suitable for rehydration, but not to have an advantage over the standard WHO/ORS.     

Double blind, randomised controlled clinical trial of hypo-osmolar oral rehydration salt solution in dehydrating acute diarrhoea in severely malnourished (marasmic) children

AIMS—To compare the clinical efficacy of hypo-osmolar oral rehydration salt (ORS) solution (224 mmol/l) and standard ORS solution (311 mmol/l) in severely malnourished (marasmic) children having less than 60% Harvard standard weight for age with dehydrating acute watery diarrhoea.
METHODS—In a double blind, randomised, controlled trial, 64 children aged 6-48 months were randomly assigned standard (n = 32) or hypo-osmolar ORS (n = 32).
RESULTS—Stool output (52.3 v 96.6 g/kg/day), duration of diarrhoea (41.5 v 66.4 hours), intake of ORS (111.5 v 168.9 ml/kg/day), and fluid intake (214.6 v 278.3 ml/kg/day) were significantly less in the hypo-osmolar group than in the standard ORS group. Percentage of weight gain on recovery in the hypo-osmolar group was also significantly less (4.3 v 5.4% of admission weight) than in the standard ORS group. A total of 29 (91%) children in the standard ORS group and 32 (100%) children in the hypo-osmolar group recovered within five days of initiation of therapy. Mean serum sodium and potassium concentrations on recovery were within the normal range in both groups.
CONCLUSION—Our findings suggest that hypo-osmolar ORS has beneficial effects on the clinical course of dehydrating acute watery diarrhoea in severely malnourished (marasmic) children. Furthermore, children did not become hyponatraemic after receiving hypo-osmolar ORS.

     

Efficacy of a packaged rice oral rehydration solution among children with cholera and cholera-like illness

In past studies, patients with cholera and cholera-like diarrhoea treated with rice oral rehydration solution (ORS) had lower purging rates and a shorter illness duration. We evaluated a new packet form of rice ORS (CeraLyte-90) in 167 boys aged 5 to 15 y, with acute, dehydrating cholera and cholera-like diarrhoea in Bangladesh. The patients were randomized to receive either CeraLyte-90 (n = 85) or glucose ORS (n = 82) and were given early feeding and early antibiotics. The efficacy of the two solutions was compared for stool output during the first 8 h, the first 24 h, and total output, duration of diarrhoea, hematocrit, serum electrolytes and requirement for unscheduled intravenous fluids. The clinical and laboratory characteristics of the two groups were comparable on admission, and most of the patients had cholera (88% and 84% in the CeraLyte and glucose groups, respectively). The mean (+/- SE) stool output was 20% less in the rice ORS group during the first 8 h of treatment (86.2+/-6.6 ml/Kg vs 108.8+/-7.9 ml/Kg, p < 0.05), but the outputs during the other time periods were similar in the two groups, although children in the rice ORS group had slightly more vomiting on day one (p < 0.05). The mean serum electrolyte concentrations in both groups of children remained within normal range. CONCLUSION: The study documents the safety and efficacy of the new, packaged rice ORS.     

Optimising Oral Rehydration Solution Composition for the Children of Europe: Clinical Trials

da Cunha Ferreira R. M. C. (Department of Paediatrics. Hospital de Santa Maria, University of Lisbon, Lisbon, Portugal). Optimising oral rehydration solution composition for the children of Europe: Clinical trials. Acta Paediatr Scand Suppl 364: 40, 1989.
Clinical trials testing different oral rehydration solutions (ORS) are reviewed. The effects of individual components and their concentrations are analysed in order to establish margins of safety for the composition of the ideal ORS for children in Europe. Glucose is the solute of choice for ORS and concentrations of 70–140 mmol/l are adequate. Glucose may he replaced by sucrose or glucose polymers. "Low" sodium concentrations (35–60 mmol/l) are advised for rehydration and maintenance in acute non-cholera diarrhoea, for children of all ages, including neonates, and for any degree of dehydration except shock. Although intended for children who are not malnourished, the European ORS should have an adequate potassium concentration (20–30 mmol/l), namely the same concentration as found in WHO-ORS. Chloride concentration depends upon other constituents of ORS, namely sodium and potassium, hut the range of 30–90 mmol/l is considered to be adequate. Base or base percursors are not required for correction of acidosis except in the severe cases that always need intravenous replacement. A relatively low osmolality seems advisable.     

Oral rehydration with a plantain flour-based solution in children dehydrated by acute diarrhea: a clinical trial

A clinical trial was conducted in order to prove the efficacy of a solution containing 50 g/1 of plantain flour and 3. 5 g/1 of sodium chloride (NaCl) for the rehydration of children with acute diarrheal diseases. 121 children were given WHO-ORS (Group A) and 117 a plantain flour-based solution (Group B). Rehydration was successful in 85. 9% in Group A and 88. 0% in Group B ( p = 0. 634). Rehydration was completed in 5. 28 h (SD 1. 99) in Group A and in 4. 88 h (SD 2. 11) in Group B ( p = 0. 132). The average solution intake for rehydration was 24. 56ml/kg/h (SD 10. 12) in Group A and 21. 17ml/kg/h (SD 9. 35) in Group B ( p = 0. 00782). The mean stool output during rehydration was 8. 45g/kg/h (SD 9. 72) in Group A and 4. 69 g/kg/h (SD 4. 98) in Group B ( p = 0. 00053). Decrease in blood levels of sodium and potassium occurred in some children in group B. The plantain flour-based solution proved effective for the treatment of dehydration due to acute diarrheal diseases and should be considered as an alternative when standard WHO-ORS is not available.     

Controlled trial of hypo-osmalar versus World Health Organization oral rehydration solution

OBJECTIVE: To compare the safety and efficacy of a hyposmolar oral rehydration solution (H-ORS) (245 mmol/liter) with the World Health Organization oral rehydration solution (WHO ORS) in cholera and acute non-cholera diarrhea. DESIGN: Controlled clinical trial. SETTING: Diarrhea training and treatment unit. METHODS: Thirty-five culture proven cholera and 135 acute non-cholera diarrheal patients randomly received H-ORS or WHO-ORS. Intake and output were measured every 4 hours. RESULTS: Analysis of the total cases revealed rehydration phase (p=0.048, 95% CI 0.64-0.99) and overall (p=0.046, 95% CI 0.70-0.99) frequency of stools to be significantly less in the H-ORS group. In the severely malnourished, the rehydration phase (p=0.032, 95% CI 0.55-97), maintenance phase (p=0.035, 95% CI 0.51-0.97) and overall (p=0.011; 0.95% CI 0.55-0.93) stool frequency were significantly decreased in the H-ORS group. The amount of ORS consumed in the maintenance phase of the cholera cases was significantly (p=0.04, 95% CI 0.44-0.98) less in the H-ORS group. All other parameters, despite showing a decreasing trend, were statistically comparable in the cholera, non-cholera and total cases. The amount of intravenous fluid needed was significantly more in the noncholera and total cases on H-ORS. In the non-breastfed cases, under two years of age, the total duration of diarrhea was significantly decreased (p=0.03; 95% CI 11.07-11.45) but the need for intravenous fluids significantly increased (p=0.02; 95% CI 109.8-112.1) in the H-ORS group. The proportion of children vomiting, the weight gain, urine passed in 24 hours, serum sodium, caloric intake and failure rate were comparable. CONCLUSIONS: H-ORS is as safe and effective as the WHO-ORS and may have some additional benefits in malnourished children.     

Acute diarrheal diseases. Treatment with carrot-rice viscous solution is more effective than ORS solution]

In infants and children, the treatment of acute diarrhoea with glucose-based electrolyte solutions results in rehydration but does not reduce the severity and duration of diarrhoea. In german-speaking countries, rice- and carrot-based solutions have a long tradition in the treatment of diarrhoea and may also reduce stool output and the duration of diarrhoea. Therefore, we evaluated the efficacy and safety of a carrot-rice-based rehydration solution (Na 57 mmol/L, n = 70) and two conventional glucose-based solutions with high or low sodium concentrations (Na 90 mmol/L, n = 48 or Na 55 mmol/L, n = 60) in a prospective study. The study subjects were Pakistani boys and girls between 3 and 48 months of age with mild or moderate dehydration. We measured duration of diarrhoea, fecal and urine output, fluid intake and serum electrolytes. The duration of diarrhoea was significantly lower (p less than 0.05) in the group receiving the carrot-rice based rehydration solution (59.5 +/- 30.9 h) than in the groups receiving the high-Na (75.5 +/- 30.5) and low-Na (74.8 +/- 32.5) glucose-electrolyte solutions. The mean fecal output (p less than 0.01) and fluid intake (p less than 0.001) were also significantly lower in the infants and children receiving the carrot-rice-based rehydration solution. No major electrolyte imbalances were observed in the three groups. We conclude that the carrot-rice-based rehydration solution was safe and more effective than two conventional glucose-electrolyte solutions in the rehydration of infants and children with acute diarrhoea.     

Hydrolyzed lactalbumin-based oral rehydration solution for acute diarrhoea in infants

The addition of different organic substrates to standard glucose oral rehydration solution (G-ORS) has been shown to improve the intestinal absorption of sodium and water, and thereby decrease stool losses. Therefore, we evaluated, in infants with acute diarrhoea, the safety and efficacy of three oral rehydration solutions (ORS) which had the same concentrations of electrolytes (with sodium 60 mmol/l) but different substrates of proteins and carbohydrates. One solution (LAD-ORS) contained hydrolyzed lactalbumin (LAD) with maltodextrin and sucrose, a second (MS-ORS) was identical but without LAD and a third (G-ORS) was standard glucose ORS. The three solutions were compared in a double-blind, randomized trial in 74 hospitalized well-nourished children in Panama and the United States. All three oral rehydration solutions were equally efficacious and safe in these children, 54% of whom were infected with rotavirus. There was no suggestion that hydrolyzed lactalbumin or maltodextrin provided any advantage over glucose-ORS in terms of stool output or in duration of diarrhoea. We conclude that all three solutions are efficacious in the therapy of acute diarrhoea in infants.