Lactoferrin and lysozyme to reduce environmental enteric dysfunction and stunting in Malawian children: study protocol for a randomized controlled trial.

BACKGROUND: Chronic childhood malnutrition, as manifested by stunted linear growth, remains a persistent barrier to optimal child growth and societal development. Environmental enteric dysfunction (EED) is a significant underlying factor in the causal pathway to stunting, delayed cognitive development, and ultimately morbidity and mortality. Effective therapies against EED and stunting are lacking and further clinical trials are warranted to effectively identify and operationalize interventions. METHODS/DESIGN: A prospective randomized placebo-controlled parallel-group randomized controlled trial will be conducted to determine if a daily supplement of lactoferrin and lysozyme, two important proteins found in breast milk, can decrease the burden of EED and stunting in rural Malawian children aged 12-23 months old. The intervention and control groups will have a sample size of 86 subjects each. All field and laboratory researchers will be blinded to the assigned intervention group, as will the subjects and their caregivers. The percentage of ingested lactulose excreted in the urine (Δ%L) after 4 h will be used as the biomarker for EED and linear growth as the measure of chronic malnutrition (stunting). The primary outcomes of interest will be change in Δ%L from baseline to 8 weeks and to 16 weeks. Intention-to-treat analyses will be used. DISCUSSION: A rigorous clinical trial design will be used to assess the biologically plausible use of lactoferrin and lysozyme as dietary supplements for children at high risk for EED. If proven effective, these safe proteins may serve to markedly reduce the burden of childhood malnutrition and improve survival. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02925026 . Registered on 4 October 2016.

A presentation of latent tropical sprue in a Canadian hospital.

Tropical sprue (TS) is a chronic diarrheal disease of unknown etiology characterized by malabsorption and small bowel mucosal abnormalities. TS affects residents of, and visitors to, endemic tropical regions. Rarely the disease may remain latent for several years, and to date, few cases of latent TS have been reported in Europe or North America. However, in our increasingly multicultural communities and in a 'global village' where travel is common, clinicians must maintain a high index of suspicion for TS in patients presenting with diarrhea and malabsorption who have traveled to endemic regions. TS may mimic common diarrheal diseases that are seen in developed nations, including celiac disease, Crohn's disease, bacterial overgrowth, and other infectious etiologies. Accordingly, once these more common etiologies have been ruled out, TS must be considered in patients presenting with diarrhea after travel to endemic regions. We present a unique Canadian case of latent TS, with a brief review of the diagnostic approach and treatment.