Undernutrition is one of the most important health issues in Kenya. Children who are chronically undernourished do not reach their full potential and are at increased risk of infectious disease. Stunting occurs in a third of Kenyan children and has severe and long-term consequences in terms of health, development, and poverty. Several studies have shown that stunting is frequently associated with subclinical inflammation of the bowel, a condition referred to as Environmental Enteropathy (EE), previously known as 'tropical sprue' or 'tropical enteropathy'. EE is clinically similar to childhood inflammatory bowel diseases (IBD), including Crohn's disease. The treatment of IBD routinely involves provision of gut immunomodulatory agents, but this approach has never been tried in EE. This proposal outlines a pilot double-blind randomised placebo-controlled trial of mesalamine (also called mesalazine - the safest immunomodulator used in IBD with least systemic activity) in treatment of severely malnourished children with EE.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
44
Mesalamine granules
Provided by Ferring Pharma
Baraka Clinic
Nairobi, Mathare, Kenya
Frequency of adverse events/serious adverse events
This trial represents the first time a member of a class of drugs are to be used in a particular vulnerable group patient group. It's primary purpose is to conduct an early evaluation of safety and acceptability in this and the study is not powered to address any specific outcomes. It represents a modified Phase IIa design
Time frame: Day 0 to day 28 and day 0 to day 56
Compliance with treatment
This trial represents the first time a member of a class of drugs are to be used in a particular vulnerable group patient group. It's primary purpose is to conduct an early evaluation of safety and acceptability in this and the study is not powered to address any specific outcomes. It represents a modified Phase IIa design
Time frame: Day 0 to day 28
Changes in height
mm/day
Time frame: Day 0 to 28 and day 0 to day 56
Changes in levels of anti-Endotoxin Core IgG (EndoCAb)
Time frame: Day 0 - Day 28 and Day 0 - Day 56
Changes in fecal calprotectin levels
Time frame: Day 0 - Day 28 and Day 0 - Day 56
Changes in plasma soluble-CD14
Time frame: Day 0 - Day 28 and Day 0 - Day 56
Changes in plasma beta-2 microglobulin
Time frame: Day 0 - Day 28 and Day 0 - Day 56
Changes in plasma neopterin
Time frame: Day 0 - Day 28 and Day 0 - Day 56
Changes in weight
g/kg/day
Time frame: Day 0 - Day 28 and Day 0 - Day 56
Changes in mid-upper arm circumference
mm/day
Time frame: Day 0 - Day 28 and Day 0 - Day 56
Changes in C-Reactive Protein
Time frame: Day 0 - Day 28, and Day 0 - Day56
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