Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639416
Recruitment Status : Completed
First Posted : December 24, 2015
Last Update Posted : February 25, 2021
Sponsor:
Collaborators:
University of Toronto
University of Malawi College of Medicine
Queen Elizabeth Central Hospital, Blantyre, Malawi
Information provided by (Responsible Party):
Liverpool School of Tropical Medicine

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.


Condition or disease Intervention/treatment Phase
Severe Malnutrition Enteritis Dietary Supplement: Polymeric formula Dietary Supplement: Elemental formula Other: Standard management Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypoallergenic and Anti-inflammatory Feeds to Treat Intestinal Inflammation in Malawian Children With Severe Acute Malnutrition: A Pilot Randomized Controlled Clinical Trial (SAM)
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : January 11, 2017
Actual Study Completion Date : January 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Active Comparator: Standard management
Standard management consists of F-100 and/or ready-to-use therapeutic food (RUTF) according to usual practice for 14 days
Other: Standard management
Standard management with F-100 and/or RUTF

Experimental: Polymeric formula
Exclusive polymeric formula supplemented with micronutrients in equivalent volume to F-100 for 14 days
Dietary Supplement: Polymeric formula
Polymeric formulae are recommended in the management of inflammatory bowel disease in children

Experimental: Elemental formula
Exclusive elemental formula supplemented with micronutrients in equivalent volume to F-100 for 14 days
Dietary Supplement: Elemental formula
Elemental formulae are recommended in cow's milk and other food intolerances in children.




Primary Outcome Measures :
  1. Change in faecal calprotectin [ Time Frame: 14 days ]
    Validated marker of intestinal inflammation


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639416


Locations
Layout table for location information
Malawi
Moyo ward, Department of Paediatrics, Queen Elizabeth Central Hospital
Blantyre, Southern Region, Malawi, Box 360
Sponsors and Collaborators
Liverpool School of Tropical Medicine
University of Toronto
University of Malawi College of Medicine
Queen Elizabeth Central Hospital, Blantyre, Malawi
Investigators
Layout table for investigator information
Principal Investigator: Stephen J Allen, MD Liverpool School of Tropical Medicine
Layout table for additonal information
Responsible Party: Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier: NCT02639416    
Other Study ID Numbers: 15.048
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Liverpool School of Tropical Medicine:
severe acute malnutrition
polymeric therapeutic formula
elemental therapeutic formula
Additional relevant MeSH terms:
Layout table for MeSH terms
Enteritis
Malnutrition
Severe Acute Malnutrition
Nutrition Disorders
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases