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Source: isrctn - Le promoteur: University of Copenhagen (Denmark)
University of Copenhagen (Denmark) MAJ Il y a 4 ans

Role of Probiotics in recovery of children with Severe Acute Malnutrition Background and study aims About 35% of global child deaths below five years of age are estimated to be caused by Undernutrition, and pneumonia and diarrhea are the two most common causes of death in undernourished children. Adding probiotics to the food of severely malnourished children may be a way to reduce the occurrence and severity of both diarrhea and airway infections in undernourished children. Studies suggest that probiotics are able to reduce the occurrence and duration of diarrhea and may reduce the risk of airway infections. Some of the probiotic studies have included mildly to moderately malnourished children, but most studies have been conducted in well-nourished populations.The main aim of the study is to measure the effect of two probiotic strains on diarrhea in children with severe acute malnutrition (SAM) when given together with the usually recommended treatment. Who can participate? Children aged 6–59 months with severe acute malnutrition. What does the study involve? Children with severe acute malnutrition admitted to a nutritional rehabilitation unit at a national referral hospital in Uganda will be recruited. All children are treated according to the WHO protocol for treatment of children with SAM. Children were randomly allocated to either receive a daily dose of probiotics or a dummy sachet of similar appearance and taste during the entire study period. The follow-up visits as an outpatient will last between 8 to 12 weeks depending on the recovery rate of the child. Each child will have body measurements performed at admission, discharge and at the follow-up visits every two weeks. Weight will be measured daily and height will be measured weekly during hospitalization. A thymus gland ultrasound scan will be carried out and blood and stool samples will be collected at admission, discharge and after 8 weeks follow-up. Diarrhea will be monitored closely with daily registration of stool frequency, stool consistency, vomiting and fever. Pneumonia is diagnosed by medical doctors.30 healthy children of the same age and from the same area will be included to collect reference samples of blood and feces and thymus scans. What are the possible benefits and risks of participating? All children will benefit from the extra attention they may get in the study especially in relation to diarrhea and pneumonia. Children that receive the probiotics may benefit from a reduced occurrence and severity of diarrhea and pneumonia. The risk associated with treatment of children with SAM with the two probiotic strains is minimal. However, as the study population is vulnerable, an independent Data Safety Monitoring Board has been established to follow safety during the study. All the procedures carried out in the study involve no or minimal risk or discomfort to the children. Where is the study run from? The study takes place at Mwanamugimu Rehabilitation Nutrition Unit, National Referral, Mulago Hospital, Department of Paediatrics and Child Health, Kampala, Uganda. When is the study starting and how long is it expected to run for? The study will take place between March 2014 and July 2015. Who is funding the study? Chr. Hansen A/S and University of Copenhagen, Denmark. Who is the main contact? Prof. Henrik Friis [email protected]

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