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

NCT ID: NCT02639416

Last Updated: 2021-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2017-01-11

Brief 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.

Conditions

Severe Malnutrition; Enteritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard management

Standard management consists of F-100 and/or ready-to-use therapeutic food (RUTF) according to usual practice for 14 days

Group Type: ACTIVE_COMPARATOR

Standard management

Intervention Type: OTHER

Standard management with F-100 and/or RUTF

Polymeric formula

Exclusive polymeric formula supplemented with micronutrients in equivalent volume to F-100 for 14 days

Group Type: EXPERIMENTAL

Polymeric formula

Intervention Type: DIETARY_SUPPLEMENT

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

Elemental formula

Exclusive elemental formula supplemented with micronutrients in equivalent volume to F-100 for 14 days

Group Type: EXPERIMENTAL

Elemental formula

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Polymeric formula

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

Intervention Type: DIETARY_SUPPLEMENT

Elemental formula

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

Intervention Type: DIETARY_SUPPLEMENT

Standard management

Standard management with F-100 and/or RUTF

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 23 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Toronto

OTHER

Sponsor Role: collaborator

Kamuzu University of Health Sciences

OTHER

Sponsor Role: collaborator

Queen Elizabeth Central Hospital, Blantyre, Malawi

UNKNOWN

Sponsor Role: collaborator

Liverpool School of Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen J Allen, MD

Role: PRINCIPAL_INVESTIGATOR

Liverpool School of Tropical Medicine

Locations

Moyo ward, Department of Paediatrics, Queen Elizabeth Central Hospital

Blantyre, Southern Region, Malawi

Countries

Malawi

Other Identifiers

15.048

Identifier Type: -

Identifier Source: org_study_id