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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 March 2021
• Main ID: NCT02639416
• Date of registration: 21/12/2015
• Prospective Registration: Yes
• Primary sponsor: Liverpool School of Tropical Medicine
• Public title: Hypoallergenic and Anti-inflammatory Feeds in Malawian Children With Severe Acute Malnutrition (SAM) SAM
• Scientific title: Hypoallergenic and Anti-inflammatory Feeds to Treat Intestinal Inflammation in Malawian Children With Severe Acute Malnutrition: A Pilot Randomized Controlled Clinical Trial (SAM)
• Date of first enrolment: January 1, 2016
• Target sample size: 95
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02639416
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Malawi

Contacts

• Name: Stephen J Allen, MD
• Affiliation: Liverpool School of Tropical Medicine

Key inclusion & exclusion criteria

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



Age minimum: 6 Months
Age maximum: 23 Months
Gender: All

Health Condition(s) or Problem(s) studied

Severe Malnutrition

Enteritis

Intervention(s)

Dietary Supplement: Elemental formula

Dietary Supplement: Polymeric formula

Other: Standard management

Primary Outcome(s)

Change in faecal calprotectin [Time Frame: 14 days]

Secondary Outcome(s)

Death [Time Frame: 1-14 days]

Days with diarrhoea [Time Frame: 1-14 days]

Episodes of sepsis [Time Frame: 1-14 days]

Weight gain [Time Frame: 1-14 days]

Secondary ID(s)

15.048

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Queen Elizabeth Central Hospital, Blantyre, Malawi

University of Malawi College of Medicine

University of Toronto