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

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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

Tracking Information
First Submitted Date  ICMJE December 21, 2015
First Posted Date  ICMJE December 24, 2015
Last Update Posted Date February 25, 2021
Actual Study Start Date  ICMJE January 1, 2016
Actual Primary Completion Date January 11, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2015)
Change in faecal calprotectin [ Time Frame: 14 days ]
Validated marker of intestinal inflammation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2015)
  • Days with diarrhoea [ Time Frame: 1-14 days ]
    number of days with 3 or more loose/watery stools
  • Weight gain [ Time Frame: 1-14 days ]
    change in weight in g/kg/day
  • Episodes of sepsis [ Time Frame: 1-14 days ]
    Clinical diagnosis
  • Death [ Time Frame: 1-14 days ]
    number of children who die
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypoallergenic and Anti-inflammatory Feeds in Malawian Children With Severe Acute Malnutrition (SAM)
Official Title  ICMJE Hypoallergenic and Anti-inflammatory Feeds to Treat Intestinal Inflammation in Malawian Children With Severe Acute Malnutrition: A Pilot Randomized Controlled Clinical Trial (SAM)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Severe Malnutrition
  • Enteritis
Intervention  ICMJE
  • Dietary Supplement: Polymeric formula
    Polymeric formulae are recommended in the management of inflammatory bowel disease in children
  • Dietary Supplement: Elemental formula
    Elemental formulae are recommended in cow's milk and other food intolerances in children.
  • Other: Standard management
    Standard management with F-100 and/or RUTF
Study Arms  ICMJE
  • 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
    Intervention: Other: Standard management
  • Experimental: Polymeric formula
    Exclusive polymeric formula supplemented with micronutrients in equivalent volume to F-100 for 14 days
    Intervention: Dietary Supplement: Polymeric formula
  • Experimental: Elemental formula
    Exclusive elemental formula supplemented with micronutrients in equivalent volume to F-100 for 14 days
    Intervention: Dietary Supplement: Elemental formula
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2021)
95
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2015)
120
Actual Study Completion Date  ICMJE January 11, 2017
Actual Primary Completion Date January 11, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 23 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02639416
Other Study ID Numbers  ICMJE 15.048
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Liverpool School of Tropical Medicine
Study Sponsor  ICMJE Liverpool School of Tropical Medicine
Collaborators  ICMJE
  • University of Toronto
  • University of Malawi College of Medicine
  • Queen Elizabeth Central Hospital, Blantyre, Malawi
Investigators  ICMJE
Principal Investigator: Stephen J Allen, MD Liverpool School of Tropical Medicine
PRS Account Liverpool School of Tropical Medicine
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP