Probiotics for children with uncomplicated severe acute malnutrition (PruSAM study): A randomized controlled trial in the Democratic Republic of Congo.

Laure B Bindels, Richard Mbusa Kambale, Joseph Ntagerwa Ntagazibwa, Joe Bwija Kasengi, Adrien Burume Zigashane, Isia Nancy Francisca, Benjamin Ntaligeza Mashukano, Gaylord Amani Ngaboyeka, Esto Bahizire, Francis Zech, Dimitri Van der Linden

Journal: The American journal of clinical nutrition 2023;117(5):976-984

PMID: 37137616

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Abstract

BACKGROUND

Severe acute malnutrition (SAM) contributes to nearly 1 million deaths annually worldwide, with diarrhea and pneumonia being the common morbidity associated with mortality.

OBJECTIVES

To assess the effect of probiotics on diarrhea, pneumonia, and nutritional recovery in children with uncomplicated SAM.

METHODS

A randomized, double-blind, placebo-controlled study was conducted involving 400 children with uncomplicated SAM randomly assigned to ready-to-use therapeutic food (RUTF) either with (n = 200) or without (n = 200) probiotics. Patients received 1 mL daily dose of a blend of Lacticasebacillus rhamnosus GG and Limosilactobacillus reuteri DSM 17938 (dosage, 2 billion colony-forming units; 50:50) or placebo during 1 mo. They were simultaneously fed with the RUTF for 6 to 12 wk, depending on patients' recovery rates. The primary outcome was the duration of diarrhea. Secondary outcomes included diarrheal and pneumonic incidence, nutritional recovery, and transfer to inpatient care rate.

RESULTS

For children with diarrhea, the number of days of disease was lower in the probiotic group (4.11; 95% CI: 3.37, 4.51) than that in the placebo group (6.68; 95% CI: 6.26, 7.13; P < 0.001). For children aged 16 mo or older, the risk of diarrhea was lower in the probiotic group (75.6%; 95% CI: 66.2, 82.9) than that in the placebo group (95.0%; 95% CI: 88.2, 97.9; P < 0.001), but no significant difference of the risk for the youngest. In the probiotic group, nutritional recovery happened earlier: at the 6th wk, 40.6% of the infants were waiting for nutritional recovery, contrasting with 68.7% of infants in the placebo group; but the nutritional recovery rate at the 12th wk was similar between the groups. Probiotics had no effect on pneumonic incidence and transfer to inpatient care.

CONCLUSIONS

This trial supports using probiotics for the treatment of children with uncomplicated SAM. Its effect on diarrhea could positively affect nutritional programs in resource-limited settings. This trial was registered https://pactr.samrc.ac.za as PACTR202108842939734.

Address: Institute of Experimental and Clinical Research, Université catholique de Louvain, Brussels, Belgium; Faculty of Medicine, Université catholique de Bukavu, Bukavu, Democratic Republic of Congo; General Pediatrics, Pediatric Department, Hôpital Provincial Général de Référence de Bukavu, Bukavu, Democratic Republic of Congo; Institut Supérieur des Techniques Médicales, Bukavu, Democratic Republic of Congo; Center for Tropical Diseases and Global Health, Université catholique de Bukavu, Bukavu, Democratic Republic of the Congo. Electronic address: [email protected].; Faculty of Medicine, Université catholique de Bukavu, Bukavu, Democratic Republic of Congo; General Pediatrics, Pediatric Department, Hôpital Provincial Général de Référence de Bukavu, Bukavu, Democratic Republic of Congo.; Ecole Régionale de Santé Publique, Université catholique de Bukavu, Bukavu, Democratic Republic of Congo.; Faculty of Medicine, Université catholique de Bukavu, Bukavu, Democratic Republic of Congo; Center for Tropical Diseases and Global Health, Université catholique de Bukavu, Bukavu, Democratic Republic of the Congo; Center for Research in Natural Sciences of Lwiro, Bukavu, Democratic Republic of the Congo; Department of Medical Microbiology, University of Nairobi, Nairobi, Kenya.; Institute of Experimental and Clinical Research, Université catholique de Louvain, Brussels, Belgium.; Metabolism and Nutrition Research Group, Louvain Drug Research Institute, Université catholique de Louvain, Brussels, Belgium.; Institute of Experimental and Clinical Research, Université catholique de Louvain, Brussels, Belgium; Pediatric Infectious Diseases, Specialized Pediatrics Service, Pediatric Department, Cliniques universitaires Saint Luc, Brussels, Belgium.

DOI: 10.1016/j.ajcnut.2023.01.019

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MeSH Terms: Infant, Humans, Child, Democratic Republic of the Congo, Probiotics, Diarrhea, Severe Acute Malnutrition, Double-Blind Method