Evidence map›Paper›PMID 25189855›Full record

Trial reportBMC medicine2014

Mesalazine in the initial management of severely acutely malnourished children with environmental enteric dysfunction: a pilot randomized controlled trial.

Kelsey D J Jones, Barbara Hünten-Kirsch, Ahmed M R Laving, Caroline W Munyi, Moses Ngari, Jenifer Mikusa, Musa M Mulongo, Dennis Odera, H Samira Nassir, Molline Timbwa and 6 more

3 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 53 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 4 pooled it
5.1field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01841099 phase1 / phase2completednot on this map

Randomised Placebo-controlled Trial of a Gut Immunomodulatory Agent (Mesalamine) to Tackle Environmental Enteropathy in Acutely Malnourished Children: A Pilot Study.

TypeinterventionalSponsorKelsey JonesRan2013 to 2014Enrolled44ConditionsMalnutritionArmsMesalamine, Placebo granules
NCT02746276 phase2unknown statusnot on this mapstarted 2016, after this paper: background citation

Pharmacokinetics of Antimicrobials and Carriage of Antimicrobial Resistance Amongst Hospitalised Children With Severe Acute Malnutrition

TypeinterventionalSponsorUniversity of OxfordRan2016 to 2017Enrolled81ConditionsMalnutritionArmsCeftriaxone, Metronidazole
NCT03174236 phase3unknown statusnot on this mapstarted 2017, after this paper: background citation

First Line Antimicrobials in Children With Complicated Severe Acute Malnutrition

TypeinterventionalSponsorUniversity of OxfordRan2017 to 2020Enrolled2,000ConditionsMalnutrition Severe, Antibiotic Resistance, Antibiotic ToxicityArmsCeftriaxone, Benzyl penicillin, Metronidazole, Placebo, Gentamicin
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 4 syntheses or guidelines pooled it, 71 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 2 countries.

Kelsey D J Jones
Barbara Hünten-Kirsch
Ahmed M R Laving
Caroline W Munyi
Moses Ngari
Jenifer Mikusa
Musa M Mulongo
Dennis Odera
H Samira Nassir
Molline Timbwa
Moses Owino
Greg Fegan
Simon H Murch
Peter B Sullivan
John O Warner
James A Berkley
Kenya Medical Research Institute · KEGovernment of KenyaImperial College London · GBUniversity of Nairobi · KEUniversity of Oxford · GBUniversity of Warwick · GB

Funding

Wellcome Trust 083579Wellcome Trust 092088Wellcome Trust 092654
6 · The paper itself

Abstract

backgroundEnvironmental enteric dysfunction (EED) is an acquired syndrome of impaired gastrointestinal mucosal barrier function that is thought to play a key role in the pathogenesis of stunting in early life. It has been conceptualized as an adaptive response to excess environmental pathogen exposure. However, it is clinically similar to other inflammatory enteropathies, which result from both host and environmental triggers, and for which immunomodulation is a cornerstone of therapy.

methodsIn this pilot double-blind randomized placebo-controlled trial, 44 children with severe acute malnutrition and evidence of EED were assigned to treatment with mesalazine or placebo for 28 days during nutritional rehabilitation. Primary outcomes were safety and acceptability of the intervention.

resultsTreatment with mesalazine was safe: there was no excess of adverse events, evidence of deterioration in intestinal barrier integrity or impact on nutritional recovery. There were modest reductions in several inflammatory markers with mesalazine compared to placebo. Depression of the growth hormone--insulin-like growth factor-1 axis was evident at enrollment and associated with inflammatory activation. Increases in the former and decreases in the latter correlated with linear growth.

conclusionsIntestinal inflammation in EED is non-essential for mucosal homeostasis and is at least partly maladaptive. Further trials of gut-specific immunomodulatory therapies targeting host inflammatory activation in order to optimize the growth benefits of nutritional rehabilitation and to address stunting are warranted. Funded by The Wellcome Trust.

trial registrationRegistered at Clinicaltrials.gov NCT01841099.

Indexed as

Inflammatory Bowel DiseasesAnti-Inflammatory Agents, Non-SteroidalChild Health ServicesChild, PreschoolDouble-Blind MethodFemaleHousingHumansInfantMaleMalnutritionMesalaminePilot ProjectsPovertySeverity of Illness IndexTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalMesalamine

Identifiers

PMID25189855
PMCPMC4243388
OpenAlexW2002794118

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.