Evidence map›Paper›PMID 29110675›Full record

Trial reportTrials2017

Lactoferrin and lysozyme to reduce environmental enteric dysfunction and stunting in Malawian children: study protocol for a randomized controlled trial.

William D Cheng, Karl J Wold, Nicole S Benzoni, Chrissie Thakwalakwa, Kenneth M Maleta, Mark J Manary, Indi Trehan

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02925026 (Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.5field-weighted citation impact, top 32% 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.

NCT02925026 nacompletednot on this map

Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction

TypeinterventionalSponsorWashington University School of MedicineRan2016 to 2017Enrolled235ConditionsEnvironmental Enteric DysfunctionArmsLactoferrin, Lysozyme, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Article
  3. Dietary supplements for intestinal inflammation.Journal of preventive medicine and hygiene · 2022
    Review
  4. Observational
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 3 countries.

William D ChengDepartment of Pediatrics, Washington University in St. Louis, One Children's Place, Campus Box 8116, Saint Louis, MO, 63110, USA.
Karl J WoldDepartment of Pediatrics, Washington University in St. Louis, One Children's Place, Campus Box 8116, Saint Louis, MO, 63110, USA.
Nicole S BenzoniDepartment of Pediatrics, Washington University in St. Louis, One Children's Place, Campus Box 8116, Saint Louis, MO, 63110, USA.
Chrissie ThakwalakwaSchool of Public Health and Family Medicine, University of Malawi, Blantyre, Malawi.
Kenneth M MaletaSchool of Public Health and Family Medicine, University of Malawi, Blantyre, Malawi.
Mark J ManaryDepartment of Pediatrics, Washington University in St. Louis, One Children's Place, Campus Box 8116, Saint Louis, MO, 63110, USA.
Indi TrehanDepartment of Pediatrics, Washington University in St. Louis, One Children's Place, Campus Box 8116, Saint Louis, MO, 63110, USA. indi@alum.berkeley.edu.ORCID http://orcid.org/0000-0002-3364-6858
University of Malawi · MWWashington University in St. Louis · USSt. Louis Children's Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic childhood malnutrition, as manifested by stunted linear growth, remains a persistent barrier to optimal child growth and societal development. Environmental enteric dysfunction (EED) is a significant underlying factor in the causal pathway to stunting, delayed cognitive development, and ultimately morbidity and mortality. Effective therapies against EED and stunting are lacking and further clinical trials are warranted to effectively identify and operationalize interventions. METHODS/

designA prospective randomized placebo-controlled parallel-group randomized controlled trial will be conducted to determine if a daily supplement of lactoferrin and lysozyme, two important proteins found in breast milk, can decrease the burden of EED and stunting in rural Malawian children aged 12-23 months old. The intervention and control groups will have a sample size of 86 subjects each. All field and laboratory researchers will be blinded to the assigned intervention group, as will the subjects and their caregivers. The percentage of ingested lactulose excreted in the urine (Δ%L) after 4 h will be used as the biomarker for EED and linear growth as the measure of chronic malnutrition (stunting). The primary outcomes of interest will be change in Δ%L from baseline to 8 weeks and to 16 weeks. Intention-to-treat analyses will be used. DISCUSSION: A rigorous clinical trial design will be used to assess the biologically plausible use of lactoferrin and lysozyme as dietary supplements for children at high risk for EED. If proven effective, these safe proteins may serve to markedly reduce the burden of childhood malnutrition and improve survival.

trial registrationClinicaltrials.gov, NCT02925026 . Registered on 4 October 2016.

Indexed as

Dietary SupplementsAge FactorsBody HeightChild DevelopmentClinical ProtocolsFemaleGrowth DisordersHumansInfantInfant Nutritional Physiological PhenomenaInfant Nutrition DisordersIntention to Treat AnalysisLactoferrinMalawiMaleMalnutritionLactoferrinMuramidaseEnvironmental enteric dysfunctionEnvironmental enteropathyInflammationLactoferrinLactuloseLysozymeMalnutritionStunting

Identifiers

PMID29110675
PMCPMC5674751
OpenAlexW2767799765

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.