The aim of this study 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. The study recruited 795 Malawian children who after stabilisation with milk feeds, 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).
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 (death, weight gain, time to cure, and prevalence of clinical symptoms) were also similar between groups. HIV seropositivity was associated with worse outcomes overall, but did not modify or confound the negative results.
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