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Probiotics and prebiotics for severe acute malnutrition (PRONUT study): a double-blind efficacy randomised controlled
Marko Kerac1, James Bunn, Andrew Seal
1Valid International, Oxford, UK. marko.kerac@gmail.com
Insights
A probiotic and prebiotic functional food did not improve nutritional outcomes for severe acute malnutrition in Malawian children. Further research is needed to explore potential benefits for reducing outpatient mortality.
Area of Science:
- Pediatrics
- Nutritional Science
- Infectious Disease Epidemiology
Background:
- Severe acute malnutrition (SAM) is a critical global health issue, causing millions of deaths annually.
- The study addresses SAM treatment in a setting with a high prevalence of HIV.
- Investigating novel therapeutic interventions for SAM is crucial.
Purpose of the Study:
- To evaluate the clinical and nutritional efficacy of a synbiotic functional food (Synbiotic2000 Forte) for treating SAM.
- To assess the impact of Synbiotic2000 Forte in a HIV-prevalent population.
- To determine if Synbiotic2000 Forte improves cure rates and reduces mortality in SAM cases.
Main Methods:
- A double-blind, randomized, placebo-controlled trial involving 795 Malawian children aged 5-168 months.
- Children received standard ready-to-use therapeutic food with or without Synbiotic2000 Forte post-stabilization.
- Primary outcome was nutritional cure; secondary outcomes included mortality, weight gain, and symptom prevalence.
Main Results:
- No significant difference in nutritional cure rates between the Synbiotic2000 Forte group (53.9%) and the placebo group (51.3%).
- Secondary outcomes, including mortality and time to cure, were similar between the groups.
- HIV seropositivity was linked to poorer outcomes but did not alter the study's main findings.
Conclusions:
- Synbiotic2000 Forte did not demonstrate improved clinical or nutritional outcomes for severe acute malnutrition in this Malawian cohort.
- A potential trend towards reduced outpatient mortality in the synbiotic group warrants further investigation.
- Future studies should explore the biological plausibility and public health impact of synbiotics on SAM-related mortality.
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).
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