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NCT Number: NCT02639416

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

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.

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Key information

Conditions

Severe Malnutrition Digestive System Diseases Enteritis Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Severe Acute Malnutrition

Age range

6 month–23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moyo ward, Department of Paediatrics, Queen Elizabeth Central Hospital

Blantyre, Southern Region, Box 360, Malawi

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 6-23 months
  • SAM diagnosed according to WHO criteria: (Weight-for-height z score <-3 and/or mid-upper arm circumference <11.5 cms and/or nutritional oedema)
  • Admitted to hospital because of SAM with medical complications or fails an appetite test
  • Completed stabilization phase and entering the second phase in refeeding; the transition Phase
  • Willing to stay on the ward for 2 weeks after the stabilization phase (travel expenses will be provided)

Exclusion criteria

  • Specific cause of malnutrition (e.g. cerebral palsy, other organ disease)
  • Sibling admitted with SAM at the same time
  • Unwilling to stay on ward for at least 2 weeks
  • Declined to give consent
  • Participating in another study

Treatment and study plan

Polymeric formula

Dietary Supplement

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

Elemental formula

Dietary Supplement

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

Standard management

Other

Standard management with F-100 and/or RUTF

Primary outcomes

  1. Change in faecal calprotectin

    Time frame: 14 days

    Validated marker of intestinal inflammation

Secondary outcomes

  1. Days with diarrhoea

    Time frame: 1-14 days

    number of days with 3 or more loose/watery stools

  2. Weight gain

    Time frame: 1-14 days

    change in weight in g/kg/day

  3. Episodes of sepsis

    Time frame: 1-14 days

    Clinical diagnosis

  4. Death

    Time frame: 1-14 days

    number of children who die

Sponsors and collaborators

Lead sponsor

Liverpool School of Tropical Medicine

Other

Collaborators

  • Kamuzu University of Health Sciences
  • Queen Elizabeth Central Hospital, Blantyre, Malawi
  • University of Toronto

Registry information

Official study title

Hypoallergenic and Anti-inflammatory Feeds to Treat Intestinal Inflammation in Malawian Children With Severe Acute Malnutrition: A Pilot Randomized Controlled Clinical Trial (SAM)

Acronym: SAM

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 24, 2015
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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