Hypoallergenic and Anti-inflammatory Feeds in Malawian Children With Severe Acute Malnutrition (SAM)
Condition: Severe Malnutrition; Enteritis
MeSH terms: Enteritis; Malnutrition; Severe Acute Malnutrition
Study type: Interventional

Summary: 
      Children with complicated severe acute malnutrition (SAM), such as inability to take adequate
      feeds, infection and diarrhoea, require in-patient management. Despite following a
      well-established World Health Organisation (WHO) protocol, outcomes are poor. Case fatality
      often exceeds 20%. Amongst survivors discharged home, many subsequently die, have long-term
      poor growth or recurrence of SAM.

      It has long been recognized that children with SAM have intestinal inflammation and that this
      persists despite management according to WHO guidelines. The inflammation is thought to
      result from increased exposure to microbial pathogens in the gut in areas with poor
      sanitation. The damaged lining of the intestine impairs food digestion and absorption, likely
      allows gut bacteria to enter the blood stream to cause sepsis and also exposes the gut immune
      cells to microbial and food antigens causing the inflammation to persist. Failure to treat
      the intestinal inflammation is likely to contribute to the poor response to treatment and
      poor long-term outcomes in many children with SAM.

      The intestinal inflammation seen in SAM is very similar to that which occurs in food
      intolerance (e.g. intolerance to cow's milk protein) and inflammatory bowel disease. In these
      conditions, the inflammation is treated very effectively with hypoallergenic ("elemental")
      and anti-inflammatory ("polymeric") formulas. These are nutritionally complete feeds that
      have a similar composition to the feeds used for nutritional rehabilitation in SAM.

      We aim to undertake a pilot study to see if an elemental and/or polymeric formula are
      tolerated by children with SAM and help to reduce intestinal inflammation. We also aim to
      learn more about the intestinal inflammation in general that occurs in SAM by observing
      carefully the effect of these specific formulae and to do in-depth metabolic analyses.
    

Detailed description: 
      We will study children admitted to the Moyo ward at the Queen Elizabeth Central Hospital,
      Blantyre, Malawi with complicated SAM. Following informed consent, children will be recruited
      once they have completed the initial stabilisation phase of management and enter the
      transition phase to nutritional rehabilitation. They will be randomly allocated to one of 3
      arms, either 1) standard feeds (F-100 and/or ready-to-use therapeutic feeds), 2) a polymeric
      therapeutic formula or 3) an elemental therapeutic formula. The alternative feeds will be
      supplemented with micronutrients to be equivalent in composition to F-100. All children will
      remain admitted to the ward for 2 weeks and receive exclusively the allocated formula. All
      other aspects of the management of SAM will follow current practice based on WHO guidelines.
    

Intervention name(s): Polymeric formula; Elemental formula; Standard management
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Polymeric formulae are recommended in the management of inflammatory bowel disease in children; Elemental formulae are recommended in cow's milk and other food intolerances in children.; Standard management with F-100 and/or RUTF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: severe acute malnutrition; polymeric therapeutic formula; elemental therapeutic formula