- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02639416
Hypoallergenic and Anti-inflammatory Feeds in Malawian Children With Severe Acute Malnutrition (SAM) (SAM)
Hypoallergenic and Anti-inflammatory Feeds to Treat Intestinal Inflammation in Malawian Children With Severe Acute Malnutrition: A Pilot Randomized Controlled Clinical Trial (SAM)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Southern Region
-
Blantyre, Southern Region, Malawi, Box 360
- Moyo ward, Department of Paediatrics, Queen Elizabeth Central Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
|
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
|
Elemental formulae are recommended in cow's milk and other food intolerances in children.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in faecal calprotectin
Time Frame: 14 days
|
Validated marker of intestinal inflammation
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days with diarrhoea
Time Frame: 1-14 days
|
number of days with 3 or more loose/watery stools
|
1-14 days
|
Weight gain
Time Frame: 1-14 days
|
change in weight in g/kg/day
|
1-14 days
|
Episodes of sepsis
Time Frame: 1-14 days
|
Clinical diagnosis
|
1-14 days
|
Death
Time Frame: 1-14 days
|
number of children who die
|
1-14 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Stephen J Allen, MD, Liverpool School of Tropical Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15.048
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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