Newswise — Treating hospitalized, severely malnourished children with a lactose-free, reduced-carbohydrate milk formula does not improve clinical outcomes, according to a study published February 26 in the open-access journal PLOS Medicine by Robert Bandsma of the Hospital for Sick Children in Toronto, Canada, James Berkley of the KEMRI/Wellcome Trust Research Programme in Kilifi, Kenya, and colleagues.

Children who are sick and have severe acute malnutrition have a high risk of death during their stay in hospital. Diarrhea from malabsorption of sugars, and refeeding syndrome - a metabolic disturbance that occurs as a result of rapid reinstitution of nutrition - may both contribute to delayed recovery and early mortality.

Doctors and nutritionists have wondered if giving alternative types of formula, such as lactose-free feeds (lactose is one of the sugars that may not be absorbed and can cause diarrhea) may be beneficial; these feeds are intermittently used and are expensive in resource-poor settings.

The study team re-designed the initial formula given to sick, severely malnourished children by eliminating lactose and reducing other sugars (carbohydrates) by about 30%, in order to reduce these risks whilst still providing sufficient vital energy and nutrients to children.

In a multi-center, double-blind trial in Kenya and Malawi, hospitalized, sick severely malnourished children with a median age of 16 months were randomized to receive the existing standard formula (418 participants) or the modified formula (425 participants).

The two groups did not differ significantly in terms of how long it took to stabilize their condition, as judged by recovery from their acute illness as well as metabolic stabilization evidenced by recovery of appetite. There were no differences in the numbers who died or suffered diarrhea between the two groups.

Importantly, biochemical analysis amongst the children in the study who had diarrhea suggested that, despite removing lactose and reducing the other carbohydrates, the lactose-free formula still presented a load of carbohydrates above that which could be absorbed by the intestines.

According to the authors, the results support the ongoing use of the current milk formulation rather than using a lactose-free formula for children who are admitted to hospital sick and severely malnourished, including those with diarrhea. Further research is needed to investigate whether a more radical reformulation of these feeds could be made whilst still providing the energy and nutrients needed by sick and severely malnourished children.

Research Article


The study was funded by the Thrasher Research Fund to RHJB and JAB. Number 9403 ( Nonfinancial support (investigational products) was provided by Nutriset ( The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing Interests:

The authors have declared that no competing interests exist.


Bandsma RHJ, Voskuijl W, Chimwezi E, Fegan G, Briend A, Thitiri J, et al. (2019) A reduced-carbohydrate and lactose-free formulation for stabilization among hospitalized children with severe acute malnutrition: A double-blind, randomized controlled trial. PLoS Med 16(2): e1002747. 


Author Affiliations:

Division of Gastroenterology, Hepatology and Nutrition, Hospital for Sick Children, Toronto, Canada

Translational Medicine Program, Hospital for Sick Children, Toronto, Canada

Center for Global Child Health, Hospital for Sick Children, Toronto, Canada

Department of Nutrition Sciences, University of Toronto, Toronto, Canada

Department of Pediatrics, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands

Department of Biomedical Sciences, College of Medicine, University of Malawi, Blantyre, Malawi

The Childhood Acute Illness and Nutrition Network (CHAIN), Nairobi, Kenya

Department of Paediatrics and Child Health College of Medicine, University of Malawi, Blantyre, Malawi

Global Child Health Group, Emma Children’s Hospital, Academic Medical Centre, Amsterdam, the Netherlands

Swansea Trials Unit, Swansea University Medical School, Swansea, United Kingdom

Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark

Center for Child Health Research, University of Tampere School of Medicine, Tampere, Finland

KEMRI/Wellcome Trust Research Programme, Kilifi, Kenya

Department of Paediatrics, Coast General Hospital, Mombasa, Kenya

Department of Laboratory Medicine, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands

London School of Hygiene & Tropical Medicine, London, United Kingdom

Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, United Kingdom


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Robert Bandsma

Division of Gastroenterology, Hepatology and Nutrition

Hospital for Sick Children
555 University Avenue
Toronto, M5G 1X8
[email protected]