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Summary Background Severe acute malnutrition affects 13 million children worldwide and causes 1–2 million deaths every year. Our aim was to assess the clinical and nutritional efficacy of a probiotic and prebiotic functional food for the treatment of severe acute malnutrition in a HIV-prevalent setting. Methods We recruited 795 Malawian children (age range 5 to 168 months [median 22, IQR 15 to 32]) from July 12, 2006, to March 7, 2007, into a double-blind, randomised, placebo-controlled efficacy trial. For generalisability, all admissions for severe acute malnutrition treatment were eligible for recruitment. After stabilisation with milk feeds, children were randomly assigned to ready-to-use therapeutic food either with (n=399) or without (n=396) Synbiotic2000 Forte. Average prescribed Synbiotic dose was 10 10 colony-forming units or more of lactic acid bacteria per day for the duration of treatment (median 33 days). Primary outcome was nutritional cure (weight-for-height >80% of National Center for Health Statistics median on two consecutive outpatient visits). Secondary outcomes included death, weight gain, time to cure, and prevalence of clinical symptoms (diarrhoea, fever, and respiratory problems). Analysis was on an intention-to-treat basis. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN19364765. Findings Nutritional cure was similar in both Synbiotic and control groups (53·9% [215 of 399] and 51·3% [203 of 396]; p=0·40). Secondary outcomes were also similar between groups. HIV seropositivity was associated with worse outcomes overall, but did not modify or confound the negative results. Subgroup analyses showed possible trends towards reduced outpatient mortality in the Synbiotic group (p=0·06). Interpretation In Malawi, Synbiotic2000 Forte did not improve severe acute malnutrition outcomes. The observation of reduced outpatient mortality might be caused by bias, confounding, or chance, but is biologically plausible, has potential for public health impact, and should be explored in future studies. Funding Department for International Development (DfID).

Severe acute malnutrition (SAM) is defined as a weight-for-height measurement of 70% or less below the median, or three SD or more below the mean National Centre for Health Statistics reference values, the presence of bilateral pitting oedema of nutritional origin, or a mid-upper-arm circumference of less than 110 mm in children age 1-5 years. 13 million children under age 5 years have SAM, and the disorder is associated with 1 million to 2 million preventable child deaths each year. Despite this global importance, child-survival programmes have ignored SAM, and WHO does not recognise the term "acute malnutrition". Inpatient treatment is resource intensive and requires many skilled and motivated staff. Where SAM is common, the number of cases exceeds available inpatient capacity, which limits the effect of treatment; case-fatality rates are 20-30% and coverage is commonly under 10%. Programmes of community-based therapeutic care substantially reduce case-fatality rates and increase coverage rates. These programmes use new, ready-to-use, therapeutic foods and are designed to increase access to services, reduce opportunity costs, encourage early presentation and compliance, and thereby increase coverage and recovery rates. In community-based therapeutic care, all patients with SAM without complications are treated as outpatients. This approach promises to be a successful and cost-effective treatment strategy.