On the basis of this review , available scientific data suggest that the administration of currently evaluated probiotic- and /or prebiotic-supplemented formula to healthy infants does not raise safety concerns with regard to growth and adverse effects .
Infant formulae are increasingly supplemented with probiotics , prebiotics , or synbiotics despite uncertainties regarding their efficacy .
The present article , developed by the Committee on Nutrition of the European Society for Paediatric Gastroenterology , Hepatology , and Nutrition , systematic ally review s published evidence related to the safety and health effects of the administration of formulae supplemented with probiotics and /or prebiotics compared with unsupplemented formulae .
Probiotics and prebiotics for severe acute malnutrition (PRONUT study): a double-blind efficacy randomised controlled trial in Malawi
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 , r and omised , placebo-controlled efficacy trial . For generalisability , all admissions for severe acute malnutrition treatment were eligible for recruitment . After stabilisation with milk feeds , children were r and omly 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 St and ard R and omised Controlled Trial , number IS RCT N19364765 . 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 )
On the basis of this review , available scientific data suggest that the administration of currently evaluated probiotic- and /or prebiotic-supplemented formula to healthy infants does not raise safety concerns with regard to growth and adverse effects .
Infant formulae are increasingly supplemented with probiotics , prebiotics , or synbiotics despite uncertainties regarding their efficacy .
The present article , developed by the Committee on Nutrition of the European Society for Paediatric Gastroenterology , Hepatology , and Nutrition , systematic ally review s published evidence related to the safety and health effects of the administration of formulae supplemented with probiotics and /or prebiotics compared with unsupplemented formulae .