An interventional study of Polymeric formula and Elemental formula in Severe Malnutrition and Enteritis, sponsored by Liverpool School of Tropical Medicine. Completed at 1 site in Malawi. Open to participants aged 6 Months to 23 Months. Per ClinicalTrials.gov, last updated 2021-02-25.
Sponsored by Liverpool School of Tropical Medicine · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Standard management consists of F-100 and/or ready-to-use therapeutic food (RUTF) according to usual practice for 14 days
Other: Standard management
Exclusive polymeric formula supplemented with micronutrients in equivalent volume to F-100 for 14 days
Dietary Supplement: Polymeric formula
Exclusive elemental formula supplemented with micronutrients in equivalent volume to F-100 for 14 days
Dietary Supplement: Elemental formula
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
Change in faecal calprotectin
Validated marker of intestinal inflammation
Time frame: 14 days
Days with diarrhoea
number of days with 3 or more loose/watery stools
Time frame: 1-14 days
Weight gain
change in weight in g/kg/day
Time frame: 1-14 days
Episodes of sepsis
Clinical diagnosis
Time frame: 1-14 days
Death
number of children who die
Time frame: 1-14 days
Plan to share: Yes
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Liverpool School of Tropical Medicine