Lactose-free milk for infants with acute gastroenteritis in a developing country: study protocol for a randomized controlled trial

Abstract

Background: Acute 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/Design: An 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. Intervention: Lactose-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.

Undernourished Children and Milk Lactose

“…The studies mentioned above are too few and small to conclude if a subgroup of undernourished children could benefit from a lactose-reduced or lactose-free diet, but ongoing studies are investigating whether reducing the carbohydrate and/or lactose content of F-75 may be beneficial in the treatment of hospitalized children with SAM. 85,86…”

“…The studies mentioned above are too few and small to conclude if a subgroup of undernourished children could benefit from a lactose-reduced or lactose-free diet, but ongoing studies are investigating whether reducing the carbohydrate and/or lactose content of F-75 may be beneficial in the treatment of hospitalized children with SAM. 85,86 Considerations Regarding Appropriate Amounts of Lactose for Undernourished Children An exclusively breast-fed child obtains up to 40% of the daily energy from lactose. The amount of lactose is considerably lower in products used for in-patient treatment of SAM and especially for F-75 used during the stabilization phase.…”

Protective effects of recombinant lactoferrin with different iron saturations on enteritis injury in young mice

“…The North American Society for Pediatric Gastroenterology and Hepatology and Nutrition estimates that the overall annual incidence of enteritis in children under 3 yr of age is 1.3 per person in developed countries and 3 per person in developing countries (Fitzsimons, 2013). Studies have found that acute enteritis can damage intestinal villous epithelial cells, leading to the malabsorption of nutrients, which seriously affects the growth and development of infants (Villaseca et al, 2005;Nabulsi et al, 2015). Furthermore, the disease not only causes serious emotional distress and fatigue for parents and children, but also increases the risk of complications due to malnutrition or impaired immune function in children (Nabulsi et al, 2015).…”

“…Studies have found that acute enteritis can damage intestinal villous epithelial cells, leading to the malabsorption of nutrients, which seriously affects the growth and development of infants (Villaseca et al, 2005;Nabulsi et al, 2015). Furthermore, the disease not only causes serious emotional distress and fatigue for parents and children, but also increases the risk of complications due to malnutrition or impaired immune function in children (Nabulsi et al, 2015). Therefore, intestinal development is crucial to the health of infants and young children and the improvement of intestinal immunity in infants has long been of scientific concern in the fields of nutrition, food, and medicine (Zhou et al, 2015;Yu et al, 2016).…”

Avaliação da conformidade de rótulos de produtos declarados como “isento de lactose”

“…Evitar completamente a lactose permite que o intestino cure e resolva as deficiências nutricionais e outros sintomas associados (Silva & Coelho, 2019). A adesão estrita à dieta sem lactose também reduz o risco de desenvolver muitas das complicações graves a longo prazo relacionadas à intolerância não tratada (Nabulsi et al, 2015).…”