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| Name | Class |
|---|---|
| Can Tho University of Medicine and Pharmacy | OTHER |
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The purpose of this study is to determine whether lactose-free milk will change diarrhea duration and severity in formula-fed infants with acute gastroenteritis presenting to pediatric wards.
More than 525 000 children die each year due to diarrheal disease, the second leading cause of death among children under five. Children from Asian countries, including Vietnamese children, frequently have lactose intolerance. In addition, gastroenteritis, specifically rotavirus-induced gastroenteritis, temporarily impairs lactase enzymes in the intestines. In a recent Cochrane review of 33 randomized and quasi-randomized trials, lactose-free diets reduced diarrhea among children younger than 5 years old. These trials, however, involved inpatients in middle-or high-income countries. Neither patient was from a developing country, where diarrheal diseases often cause significant morbidity and mortality. The purpose of this study is to determine whether lactose-free milk will change the duration and severity of diarrhea in Vietnamese infants with acute gastroenteritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Lactose-free milk formula (Frisolac LF ®) |
|
| Placebo | Placebo Comparator | Regular infant milk formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactose-free milk formula (Frisolac LF ®) | Dietary Supplement | Following the initial rehydration phase, children were alternately assigned to receive 100 ml/kg/day of either lactose-free or lactose-containing formula |
| Measure | Description | Time Frame |
|---|---|---|
| Change in diarrhea duration | llness onset and last diarrhoeal stool (the number of days with 3 or more loose or watery stools) | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Weight gain | 7 days | |
| Severity of diarrhea according to the modified Vesikari score | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Can Tho Children Hospital | Recruiting | Can Tho | 0292 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24173771 | Result | MacGillivray S, Fahey T, McGuire W. Lactose avoidance for young children with acute diarrhoea. Cochrane Database Syst Rev. 2013 Oct 31;2013(10):CD005433. doi: 10.1002/14651858.CD005433.pub2. | |
| 15279342 | Result | Simakachorn N, Tongpenyai Y, Tongtan O, Varavithya W. Randomized, double-blind clinical trial of a lactose-free and a lactose-containing formula in dietary management of acute childhood diarrhea. J Med Assoc Thai. 2004 Jun;87(6):641-9. |
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Randomised Controlled Trial
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