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| ID | Type | Description | Link |
|---|---|---|---|
| SSC 2223 | Other Identifier | KEMRI Scientific Steering Committee |
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| Name | Class |
|---|---|
| Imperial College London | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesalamine | Experimental | Mesalamine. Mesalamine granules. 30 mg/kg/day oral for 7 days followed by 50 mg/kg/day oral for 21 days if tolerated. |
|
| Placebo granules | Placebo Comparator | Placebo granules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesalamine | Drug | Mesalamine granules |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Day 0 to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in height | mm/day | Day 0 to 28 and day 0 to day 56 |
| Changes in levels of anti-Endotoxin Core IgG (EndoCAb) | Day 0 - Day 28 and Day 0 - Day 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelsey DJ Jones, MBBS BA MRCPCH | KEMRI-Wellcome Trust Research Programme and Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baraka Clinic | Nairobi | Mathare | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25189855 | Derived | Jones KD, Hunten-Kirsch B, Laving AM, Munyi CW, Ngari M, Mikusa J, Mulongo MM, Odera D, Nassir HS, Timbwa M, Owino M, Fegan G, Murch SH, Sullivan PB, Warner JO, Berkley JA. Mesalazine in the initial management of severely acutely malnourished children with environmental enteric dysfunction: a pilot randomized controlled trial. BMC Med. 2014 Aug 14;12:133. doi: 10.1186/s12916-014-0133-2. |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| Placebo granules | Drug | Provided by Ferring Pharma |
|
| Changes in fecal calprotectin levels | Day 0 - Day 28 and Day 0 - Day 56 |
| Changes in plasma soluble-CD14 | Day 0 - Day 28 and Day 0 - Day 56 |
| Changes in plasma beta-2 microglobulin | Day 0 - Day 28 and Day 0 - Day 56 |
| Changes in plasma neopterin | Day 0 - Day 28 and Day 0 - Day 56 |
| Changes in weight | g/kg/day | Day 0 - Day 28 and Day 0 - Day 56 |
| Changes in mid-upper arm circumference | mm/day | Day 0 - Day 28 and Day 0 - Day 56 |
| Changes in C-Reactive Protein | Day 0 - Day 28, and Day 0 - Day56 |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |