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A double-blind clinical trial comparing World Health Organization oral rehydration solution with a reduced osmolarity solution containing equal amounts of sodium and glucose.

OBJECTIVE: To compare the safety and efficacy of an oral rehydration solution (ORS) containing 75 mmol/L of sodium and glucose each with the standard World Health Organization (WHO) ORS among Egyptian children with acute diarrhea. METHODS: One hundred ninety boys, aged 1 to 24 months, who were admitted to the hospital with acute diarrhea and signs of dehydration were randomly assigned to receive either standard ORS (311 mmol/L) or a reduced osmolarity ORS (245 mmol/L). Intake and output were measured every 3 hours. RESULTS: In the group treated with reduced osmolarity ORS, the mean stool output during the rehydration phase was 36% lower (95% confidence interval, 1%, 100%) than in those treated with WHO ORS. The relative risk of vomiting during the rehydration phase was significantly lower in children treated with reduced osmolarity ORS (relative risk, 2.4; 95% confidence interval, 1.2, 4.8). During the maintenance phase, stool output, mean intake of food and ORS, duration of diarrhea, and weight gain were similar in the treatment groups. The relative risk of treatment failure (need for unscheduled administration of intravenous fluids) was significantly increased in children receiving standard WHO ORS (relative risk, 7.9; 95% confidence interval, 1.1, 60.9). The mean serum sodium concentration at 24 hours was significantly lower in children receiving the reduced osmolarity ORS solution (134 +/- 6 mEq/L) than in children receiving the standard WHO ORS (138 +/- 7 mEq/L) (p < 0.001). The relative risk of the development or worsening of hyponatremia was not increased in children given the reduced osmolarity ORS, and urine output was similar in the treatment groups. CONCLUSION: The reduced osmolarity ORS has beneficial effects on the clinical course of acute diarrhea in children by reducing stool output, and the proportion of children with vomiting during the rehydration phase, and by reducing the need for supplemental intravenous therapy. These results provide support for the use of a reduced osmolarity ORS in children with acute noncholera diarrhea.

Acute Disease↗

A controlled trial comparing the efficacy of rice-based and hypotonic glucose oral rehydration solutions in infants and young children with gastroenteritis.

A prospective randomized trial was conducted to compare the efficacy of a rice-based oral rehydration solution (ORS) with glucose ORS in infants and children under 5 years of age with acute diarrhoea and mild to moderate dehydration (< 10%). One hundred children presenting to a large metropolitan teaching hospital were eligible for entry to the study and were randomized to receive rice ORS or glucose ORS. Outcome measures were stool output (SO), duration of illness (DD) and recovery time to introduction of other fluids (RTF) and diet (RTD). Significant differences were found for all outcome measures in favour of the rice ORS group. Mean SO was lower (160 vs 213 mL; P < 0.02), mean DD was reduced (17.3 vs 24.3 h; P = 0.03) and median RTF was decreased (12.7 vs 18.1 h; P < 0.001) in the rice ORS group compared with the glucose ORS group. The median time to introduction of diet and mean length of hospital stay showed similar significant reductions. Our study has shown rice ORS to be an acceptable alternative to glucose ORS in young children and have shown that it is significantly more effective in reducing the course of diarrhoeal illness and the time taken to return to normal drinking and eating habits.

Child, Preschool↗

Reduced osmolarity oral rehydration solution for persistent diarrhea in infants: a randomized controlled clinical trial.

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.

Bicarbonates↗

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

UNLABELLED: 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.

Adolescent↗

Oral rehydration solution for acute diarrhea prevents subsequent unscheduled follow-up visits.

BACKGROUND: Oral rehydration solutions (ORS) for the treatment of acute diarrhea remain an underutilized therapy in the United States, despite multiple clinical trials confirming their efficacy and safety. Economic barriers to their use have been identified. OBJECTIVE: To determine whether providing ORS to patients at the time of their office visit for acute diarrhea can increase ORS utilization and reduce unscheduled follow-up visits. DESIGN: Randomized, controlled clinical trial. SETTING: Seven health centers of a large health maintenance organization. PARTICIPANTS: Children (N = 479) 0 to 60 months of age with acute diarrhea (at least three watery or loose stools in the previous 24 hours for </=7 days). INTERVENTION: Prescription for 2 quarts of ORS filled for free at on-site pharmacy plus written instructions versus written instructions alone. PRIMARY OUTCOME MEASURES: Self-reported use of ORS; unscheduled follow-up visits in office, urgent care, and/or emergency department setting. RESULTS: Subjects in the intervention group were significantly more likely to use ORS after the initial office visit (85% vs 71%; RR: 1.19; 95% CI: 1.08-1.32). Of the standard treatment group subjects, 40 (17.3%) sought unscheduled follow-up care for diarrhea versus 27 (10.9%) of the intervention group subjects (RR: 0.63; 95% CI: 0.40-0.99). Subjects seeking unscheduled follow-up care tended to younger (15.7 vs 19.4 months old), have more stools (7.1 vs 6.2 stools), and more vomiting episodes (4.1 vs 3.0) in the 24 hours before initial evaluation than those not seeking unscheduled follow-up care. Multivariate analysis showed that randomization to the intervention group was associated with a 25% reduction in unscheduled follow-up visits for acute diarrhea. CONCLUSIONS: Providing ORS to families at the time of their office visit for acute diarrhea is associated with a significant increase in ORS use and substantially reduces the need for unscheduled follow-up visits. Health maintenance organizations should consider routine provision of ORS to children presenting with acute diarrhea.

Acute Disease↗

Randomized, controlled, clinical trial of rice versus glucose oral rehydration solutions in infants and young children with acute watery diarrhoea.

A randomized clinical trial was carried out to compare a packaged ready-to-mix rice oral rehydration solution (ORS) to the standard glucose ORS for the treatment of childhood diarrhoea. Children were of either gender, aged 3-35 months, presenting with a history of watery diarrhoea for 72 h or less. The main outcomes examined were stool output, ORS intake, duration of diarrhoea and nutritional recovery during follow-up at 16 d of illness. Stool output in the first 24 h (106 vs 107 g kg(-1)), ORS intake in clinic (93 vs 102 ml per motion) and duration of diarrhoea (88 h vs 81 h) were similar in the two treatment groups. The few episodes that became persistent were similar (2%) in the two groups. The weight gain during follow-up was similar in the two ORS groups.

Acute Disease↗

An optimal rice-based oral rehydration solution: the effect of different concentrations of amylase on production of short chain polymers of glucose.

As part of a plan to develop a rice-based oral rehydration solution containing short polymers of glucose instead of glucose, we determined the concentration of amylase that would yield the largest amount of short chain polymers. Thai rice (25 g) was boiled with 500 ml of distilled water for 30 min. Of 200 ml supernatant rice water obtained, 100 ml were digested with different amounts of amylase after cooling to 50 degrees C for 60 min, boiled for 5 min, and centrifuged (10,000 g, 25 degrees C) for 60 min. The resulting supernatant (80 ml) was freeze-dried; 1.75 g of the powder obtained were dissolved in 3.5 ml of water, passed through a Bio-Gel P2 column to separate short chain polymers (2-9 molecules of glucose) and long chain polymers (> 9 molecules of glucose), which were identified by spectrophotometry (lambda = 190 nm) or by high performance liquid chromatography. Ten mg of amylase (equivalent to 12,000 modified Wohlgemath units) per 100 ml of rice water was optimal for the production of short polymers of glucose from rice.

Amylases↗

A 3-hour quantitative comparison of glucose-based versus rice-based oral rehydration solution intake by children with diarrhoea in Port Moresby General Hospital.

Measurements were made of the intake of a WHO/UNICEF glucose-based and a rice cereal-based oral rehydration solution (ORS) by children with diarrhoea. Twenty children who presented to the Children's Outpatient Department at Port Moresby General Hospital with acute diarrhoea and mild dehydration were randomly assigned to an ORS and measurements were taken over the following 3 hours. For data analysis, the patients were paired by weight. Testing the means of the paired samples by t test showed that there was no significant difference between the amount of rice ORS and the amount of glucose ORS taken over 3 hours.

Body Weight↗

Evaluation of a nutritive oral rehydration solution for the treatment of calf diarrhoea.

The essential constituents of a conventional oral rehydration solution (ORS) are sodium, glucose and a bicarbonate precursor. The glucose promotes sodium uptake but because these solutions are isotonic, it is insufficient to sustain calorie requirements. This paper examines the performance of a novel ORS with over three times the conventional glucose concentration, by comparing it with two leading commercial ORSs in calves with induced Escherichia coli diarrhoea. This solution showed greater ability than the current market-leading ORS to repair extracellular fluid and plasma volume and to correct both hyponatraemia and metabolic acidosis, especially in more severely affected calves. In acidotic calves it was more effective in correcting hyperkalaemia, probably by supplying glucose to promote cellular potassium uptake as well as by correcting the acidosis. It therefore appears possible to depart from the traditional isotonic formulations for calf ORSs and gain significant nutritional support while retaining effective rehydration and correction of acid-base and electrolyte disturbances. This seems especially important in young animals where energy deprivation imposes a particular penalty; the use of hypertonic ORSs should not, however, be extended to other species without further research.

Acid-Base Equilibrium↗

Evaluation of an oral rehydration solution with Na+ 60 mmol/l in infants hospitalized for acute diarrhoea or treated as outpatients.

An oral rehydration solution (ORS) containing 60 mmol/l of Na+ (ORS60) was compared in a randomized trial with the ORS of WHO formula (Na+ 90 mmol/l = ORS90) for the treatment of diarrhoeal dehydration in 66 hospitalized infants aged 3 to 34 months. The infants had a 5 +/- 3% dehydration, and received within 6-10 hours 76 +/- 32 ml/kg of ORS60 or 74 +/- 41 ml/kg of ORS90 corresponding to a sodium input of 4.6 +/- 1.9 mmol/kg and 6.6 +/- 3.7 mmol/kg, respectively. Both treatments were found adequate and equally effective for the correction of dehydration and sodium deficit. The same ORS60 was also compared to a commercial low sodium glucose-electrolyte solution (sodium 35 mmol/l, glucose 3.5 milligrams) for ambulatory treatment of acute diarrhoea in infants. Satisfactory rehydration was achieved within 6 hours in 19 of 23 infants receiving ORS60 as opposed to 6 of 18 infants receiving the commercial solution (p less than 0.001); the poor result with the latter was in most cases attributed to a refusal by the infant to consume the sweetish solution. It is concluded that ORS60 is suitable for the treatment of isotonic diarrhoeal dehydration in hospitalized children as well as outpatients.

Acute Disease↗

Fallibility of plasma urea and creatinine as indices of renal function in diarrhoeic calves treated with conventional or nutritional oral rehydration solutions.

Changes in plasma urea, creatinine and glomerular filtration rate (GFR) were measured in calves before and after development of diarrhoea and during treatment with a conventional (WHO-type) or a nutritional oral rehydration solution (ORS). Changes in urea and creatinine failed to represent the extent of pre-renal failure. The two ORSs differed in their impact on GFR with the nutritional ORS improving GFR whereas with the WHO-type solution it deteriorated further.

Animals↗

Optimising oral rehydration solution composition in model systems: studies in normal mammalian small intestine.

Small intestinal perfusion studies have been carried out in animals to evaluate the role of the individual constituents of oral rehydration solution (ORS), in order to draw some conclusions relating to the optimal composition of ORS. Two commercially available ORS, Dioralyte and Rehidrat have also been compared to the World Health Organisation (WHO) standard solution. Maximum rate of water absorption occurred with the WHO solution and least with Rehidrat. The findings of the perfusion studies suggest that in the normal small intestine, optimal water absorption occurs from a solution containing 60 mmol/l of sodium and 80-120 mmol/l of glucose. The addition of bicarbonate and citrate at concentrations present in ORS does not appear to have a significant effect on water absorption. The addition of glycine and diglycine to the standard ORS reduced the net rate of absorption of sodium and water, probably because of the effect of increased osmoality.

Animals↗

Rice-based oral rehydration solution shown to be better than glucose-ORS as treatment of non-dysenteric diarrhoea in children in rural Bangladesh.

Mothers living in rural Bangladesh were provided with either rice-based oral rehydration solution (rice-ORS) (Group A) or glucose-ORS (Group B) for treating non-dysenteric diarrhoea in their children aged under 5. Mothers living in a third area (Group C) were advised to use locally available treatment facilities, mainly unregistered medical practitioners. The incidence and duration of diarrhoea was recorded in all children over a two-year period. The outcome of each episode was recorded either as a success if the mother reported her child had recovered or as a failure if the child died or was admitted to hospital. Mothers in Group A used rice-ORS as the only treatment for 71% of episodes of non-dysenteric diarrhoea, mothers in Group B used glucose-ORS as the sole treatment in 60% of episodes, while mothers in Group C used drugs alone in 55% of episodes. Almost all children recovered successfully but the duration of diarrhoea differed significantly between groups: in the group treated with rice-ORS, 60% of children recovered within 3 days and less than 1% had diarrhoea which lasted for more than 14 days. By the criteria of early recovery and low rate of prolongation of diarrhoea, rice-ORS was found to be better than glucose-ORS.

Bangladesh↗

Composition and preliminary evaluation of a hydrolyzed rice-based oral rehydration solution for the treatment of acute diarrhea in children.

OBJECTIVE: The purpose of this study was to experimentally develop and clinically evaluate the safety and potential usefulness of a rice-based, short glucose polymer oral rehydration solution (ORS), Amylyte, in the treatment of acute diarrhea. Amylyte has a similar osmolality but a higher caloric density than the WHO ORS. METHODS: Different amounts of rice were cooked in 500 ml of water containing salts (1.5 g NaCl, 600 mg KCl, and 150 mg CaCl2) with varying amounts of thermophilic amylase (252,500 modified Wohlgemuth units). Amylase (25 mg) thinned the gluey rice water when 100 g of rice was cooked in 500 ml of water for 10 minutes. The volume of the resultant supernatant (Amylyte) was approximately 250 ml. A two-part, clinical case study was performed. In study 1, 12 children with diarrhea and mild dehydration were studied to determine the safety of Amylyte. In study 2, Amylyte and the WHO ORS were given to 24 and 31 male children with acute diarrhea and moderate to severe dehydration, respectively. RESULTS: 92-96% of the rice amylose and amylopectin were converted to short polymers of glucose (3-9 molecules of glucose). The osmolality of 7,994 packages used to make the Amylyte solution ranged between 277-340 mOsm/kg. The mean electrolyte composition was Na+ = 68 mEq/L, K+ = 20 mEq/L, Cl = 73 mEq/L, the caloric density 425 kcal/L and rice proteins 0.7 g/L. In study 1, 12 children with diarrhea and mild dehydration were rehydrated successfully with Amylyte ORS and the diarrhea ceased within 48 hours. None developed clinical features of carbohydrate intolerance. In study 2, an open-label clinical case study, children with acute diarrhea given Amylyte ORS had significantly less stool output than children given the WHO ORS. CONCLUSIONS: Amylyte ORS has the advantages of a higher caloric density than the WHO ORS and shares a simple preparation of appropriate osmolality and electrolyte composition. It can safely and effectively rehydrate children with acute diarrhea and dehydration.

Acute Disease↗

Effect of perfusion of oral rehydration solutions containing glucose polymers from corn on disaccharidases and mucosal morphology in rat small intestines.

This study aims to determine the effect of glucose and glucose polymers (GP) from corn in oral rehydration solutions (ORS) on disaccharidases and morphometric measurements in small intestinal mucosa of rats. ORS containing standard composition of salts as in WHO ORS and 2, 5, or 10 per cent glucose or GP [initial glucose polymers, long chain (> 9 molecules) and short chain (2-9 molecules) glucose polymers] from corn were infused into the duodenum of 72 Sprague-Dawley rats (250-350 g). Six rats were sham operated as controls. The levels of lactase, sucrase, maltase, palatinase, and glucoamylase enzymes were higher in rats infused with ORS-containing glucose or GP than control rats. Villus height, villus width, and crypt height in corresponding segments of duodenum, jejunum, and ileum were not significantly different between rats perfused with ORS containing glucose polymers from corn and those with ORS containing glucose. ORS containing GP from corn have no adverse effects on small intestinal enzymes and morphometric measurements.

Animals↗

Evaluation of three oral rehydration solutions designed for use in developed communities.

One hundred and sixteen children (less than 2 years old) admitted to a London hospital with acute gastroenteritis were randomized to receive either an oral rehydration solution (ORS) with low sodium and high glucose concentration (Na+ 35, glucose 200 mmol/L), an ORS with a high sodium but low glucose concentration (Na+ 60, glucose 111 mmol/L), or an ORS containing glycine and a glucose polymer (Na+ 50, glucose 50, glycine 50 mmol/L). Clinical, biochemical and haematological features of the three groups were similar on admission. Rotavirus was common (31%); the majority of children had minimal dehydration or acid-base disturbance. The clinical outcome, including ORS intake, prevention of dehydration, rehydration, and duration of hospital stay was similar in the three treatment groups. All initial electrolyte abnormalities were corrected; no child developed hypernatraemia or hyponatraemia. At 24 h, the mean serum urea was higher in those who received the ORS containing glycine than in other groups, and it had not fallen significantly since admission. Eighteen per cent of children had carbohydrate intolerance: four children with greater than or equal to 2% reducing substances in their stool had all received ORS with a high glucose content and had numerous watery green stools containing rotavirus. All ORS solutions were safe and effective for rehydration and correction of biochemical abnormalities, however carbohydrate intolerance was more prevalent in children who received the ORS with a high glucose content.

Acid-Base Equilibrium↗

Clinical experience with a hypotonic oral rehydration solution in acute diarrhoea.

A hypotonic oral rehydration salts (ORS) solution with total osmolality of 224 mosmol/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.

Acute Disease↗

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)

Acute Disease↗