Hypoallergenic and Anti-inflammatory Feeds in Malawian Children With Severe Acute Malnutrition (SAM)

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.

Conditions

• Severe Malnutrition
• Enteritis

Interventions

DIETARY_SUPPLEMENT

Polymeric formula

Polymeric formulae are recommended in the management of inflammatory bowel disease in children

DIETARY_SUPPLEMENT

Elemental formula

Elemental formulae are recommended in cow's milk and other food intolerances in children.

OTHER

Standard management

Standard management with F-100 and/or RUTF

Sponsors & Collaborators

• University of Toronto

  collaborator OTHER

• Kamuzu University of Health Sciences

  collaborator OTHER

• Queen Elizabeth Central Hospital, Blantyre, Malawi

  collaborator UNKNOWN

• Liverpool School of Tropical Medicine

  lead OTHER

Principal Investigators

• Stephen J Allen, MD · Liverpool School of Tropical Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

23 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-01

Primary Completion

2017-01-11

Completion

2017-01-11

Countries

• Malawi

Study Locations