Hypoallergenic and Anti-inflammatory Feeds in Malawian Children With Severe Acute Malnutrition (SAM) (SAM)
|ClinicalTrials.gov Identifier: NCT02639416|
Recruitment Status : Unknown
Verified November 2016 by Liverpool School of Tropical Medicine.
Recruitment status was: Recruiting
First Posted : December 24, 2015
Last Update Posted : November 3, 2016
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
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.
- Change in faecal calprotectin [ Time Frame: 14 days ]Validated marker of intestinal inflammation
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639416
|Contact: Stephen J Allen, MD||0044 (0)151 705 email@example.com|
|Contact: Cheryl Pace, MPharm||+44 (0)151 705 firstname.lastname@example.org|
|Moyo ward, Department of Paediatrics, Queen Elizabeth Central Hospital||Recruiting|
|Blantyre, Southern Region, Malawi, Box 360|
|Contact: Rosalie Bartels 265(0)997599665 email@example.com|
|Principal Investigator:||Stephen J Allen, MD||Liverpool School of Tropical Medicine|