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Probiotics and prebiotics for severe acute malnutrition (PRONUT study): a double-blind efficacy randomised controlled trial in Malawi

Kerac, M., Bunn, J., Seal, A., Thindwa, M., Tomkins, A., Sadler, K., Bahwere, P. and Collins, S. (2009) 'Probiotics and prebiotics for severe acute malnutrition (PRONUT study): a double-blind efficacy randomised controlled trial in Malawi'. Lancet, Vol 374, Issue 9684, pp. 136-144.

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Abstract

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 1010 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). © 2009 Elsevier Ltd. All rights reserved.

Item Type: Article
Additional Information: Cited By (since 1996): 4 Export Date: 24 November 2009 Source: Scopus CODEN: LANCA doi: 10.1016/S0140-6736(09)60884-9 PubMed ID: 19595348 Language of Original Document: English Correspondence Address: Kerac, M.; Valid International, Oxford, United Kingdom; email: marko.kerac@gmail.com Chemicals/CAS: ceftriaxone, 73384-59-5, 74578-69-1; chloramphenicol, 134-90-7, 2787-09-9, 56-75-7; ciprofloxacin, 85721-33-1; cotrimoxazole, 8064-90-2; gentamicin, 1392-48-9, 1403-66-3, 1405-41-0 Tradenames: synbiotic2000 forte, Medipharm, Sweden Manufacturers: Medipharm, Sweden
Uncontrolled Keywords: antibiotic agent ceftriaxone chloramphenicol ciprofloxacin cotrimoxazole gentamicin prebiotic agent probiotic agent synbiotic2000 forte unclassified drug adolescent anthropometry article child clinical effectiveness clinical trial controlled clinical trial controlled study death diarrhea double blind procedure female fever functional food health care organization hospital admission human Human immunodeficiency virus infection Human immunodeficiency virus prevalence infant kwashiorkor lactic acid bacterium major clinical study Malawi male milk mortality nutritional assessment nutritional deficiency outcome assessment outpatient preschool child prevalence priority journal randomized controlled trial respiratory tract disease school child sepsis severe acute malnutrition time treatment outcome wasting syndrome weight gain Acute Disease Child Nutrition Disorders Child, Preschool Dietary Supplements Double-Blind Method HIV Seropositivity Humans Kaplan-Meiers Estimate Nutrition Assessment Nutritional Status Probiotics Severity of Illness Index Statistics, Nonparametric
Subjects: WS Pediatrics > Diseases of Children and Adolescents > By System > WS 312 Diarrheal disorders
WD Disorders of Systemic, Metabolic or Environmental Origin, etc > Nutrition Disorders > WD 100 General works
WS Pediatrics > Diseases of Children and Adolescents > General Diseases > WS 200 General works
WC Communicable Diseases > Virus Diseases > Acquired Immunodeficiency Syndrome. HIV Infections > WC 503 Acquired immunodeficiency syndrome. HIV infections
WS Pediatrics > Child Care. Nutrition. Physical Examination > WS 115 Nutritional requirements. Nutrition disorders
WD Disorders of Systemic, Metabolic or Environmental Origin, etc > Nutrition Disorders > WD 105 Deficiency diseases
WA Public Health > Health Problems of Special Population Groups > WA 395 Health in developing countries
WS Pediatrics > By Age Groups > WS 430 Infancy
WS Pediatrics > WS 100 General works
WS Pediatrics > Diseases of Children and Adolescents > By System > WS 310 Digestive system
WS Pediatrics > By Age Groups > WS 440 Preschool child
WS Pediatrics > By Age Groups > WS 460 Adolescence (General)
Digital Object Identifer (DOI): https://doi.org/10.1016/S0140-6736(09)60884-9
Depositing User: Pauline Anderson
Date Deposited: 12 Mar 2010 15:03
Last Modified: 18 May 2018 14:20
URI: http://archive.lstmed.ac.uk/id/eprint/298

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