Trial reportTrials2015
Lactose-free milk for infants with acute gastroenteritis in a developing country: study protocol for a randomized controlled trial.
Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02246010 (Does Intake of Lactose-free Milk in Infants With Acute Gastroenteritis in a Developing Country Shorten the Duration of Diarrhea? A Randomized Clinical Trial.), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Does Intake of Lactose-free Milk in Infants With Acute Gastroenteritis in a Developing Country Shorten the Duration of Diarrhea? A Randomized Clinical Trial.
Who cites it
0 citing papers in PubMed, 8 citations in OpenAlex.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAcute gastroenteritis is a major cause of pediatric morbidity and mortality, accounting for 15% of all childhood deaths worldwide. In developing countries, diarrheal diseases continue to be a major public health burden. Evidence from developed countries suggests that intake of lactose-free milk during diarrheal episodes may reduce the duration of the illness in pediatric inpatients. It is unknown whether lactose-free milk reduces the severity or duration of acute gastroenteritis in infants treated in outpatient settings in developing countries where diarrhea is more severe, and results in higher morbidities and mortalities. We hypothesize that lactose-free milk intake during acute gastroenteritis would significantly decrease the duration and severity of diarrhea in infants presenting to the Emergency Department (ED), as compared with lactose-containing milk. METHODS/
designAn open-label randomized clinical trial. STUDY POPULATION: 40 infants with acute gastroenteritis, age between 2 and 12 months, presenting to the ED, will be randomized to control or intervention group.
interventionLactose-free milk, whereas the control group will continue on regular infant formula for a total of 7 days. Infants will be followed up for 7 days. OUTCOME MEASURES: Diarrhea duration, weight loss, illness clinic visits, hospitalization rate, parental satisfaction, and time to symptom resolution. STATISTICAL ANALYSIS: Descriptive and regression analysis will be conducted under the intention-to-treat basis by using SPSS version 21. DISCUSSION: Acute gastroenteritis is a public health burden for developing countries, with a significant impact on infant morbidity and mortality. Provision of infant formula that may reduce the duration and severity of diarrhea can decrease this burden in countries with limited healthcare resources, like Lebanon. The findings from this study are anticipated to provide evidence-based dietary recommendations for ambulatory infants with acute diarrhea in developing countries.
trial registrationClinicalTrials.gov NCT02246010; September 2014.
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