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

NCT02639416 | Completed DMC

• 1 other identifier: 15.048
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Malnutrition; Enteritis

Keywords

severe acute malnutrition; polymeric therapeutic formula; elemental therapeutic formula

Outcome Measures

Primary Outcomes (1)

• Change in faecal calprotectin

  Validated marker of intestinal inflammation

  14 days

Secondary Outcomes (4)

• Days with diarrhoea

  1-14 days

• Weight gain

  1-14 days

• Episodes of sepsis

  1-14 days

• Death

  1-14 days

Study Arms (3)

Standard management

ACTIVE COMPARATOR

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

Other: Standard management

Polymeric formula

EXPERIMENTAL

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

Dietary Supplement: Polymeric formula

Elemental formula

EXPERIMENTAL

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

Dietary Supplement: Elemental formula

Interventions

Polymeric formula DIETARY_SUPPLEMENT

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

Polymeric formula

Elemental formula DIETARY_SUPPLEMENT

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

Elemental formula

Standard management OTHER

Standard management with F-100 and/or RUTF

Standard management

Eligibility Criteria

• Age: 6 Months - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Liverpool School of Tropical Medicine: lead
• University of Toronto: collaborator
• Kamuzu University of Health Sciences: collaborator
• Queen Elizabeth Central Hospital, Blantyre, Malawi: collaborator

Study Sites (1)

Moyo ward, Department of Paediatrics, Queen Elizabeth Central Hospital

Blantyre, Southern Region, Box 360, Malawi

Location

MeSH Terms

Conditions

Malnutrition; Enteritis; Severe Acute Malnutrition

Interventions

Food, Formulated

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Foods, Specialized; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Stephen J Allen, MD

  Liverpool School of Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: December 24, 2015
• Study Start: January 1, 2016
• Primary Completion: January 11, 2017
• Study Completion: January 11, 2017
• Last Updated: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

MA (1)