Evidence map›Paper›PMID 30721997›Full record

Trial reportThe Journal of infectious diseases2019

The Effects of Recombinant Human Lactoferrin on Immune Activation and the Intestinal Microbiome Among Persons Living with Human Immunodeficiency Virus and Receiving Antiretroviral Therapy.

Ornella Sortino, Kathy Huppler Hullsiek, Elizabeth Richards, Adam Rupert, Andrea Schminke, Namo Tetekpor, Mariam Quinones, Rachel Prosser, Tim Schacker, Irini Sereti and 1 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01830595 (Recombinant Lactoferrin to Reduce Immune Activation and Coagulation Among HIV Positive Patients), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 20% 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.

NCT01830595 phase2completednot on this map

Recombinant Lactoferrin to Reduce Immune Activation and Coagulation Among HIV Positive Patients

TypeinterventionalSponsorJason BakerRan2014 to 2018Enrolled55ConditionsHIV InfectionArmsRecombinant Lactoferrin, Placebo
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Article
  6. Effects of Lactoferrin andAnimals : an open access journal from MDPI · 2024
    Article
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. The gut microbiome and frailty.Translational research : the journal of laboratory and clinical medicine · 2020
    Review
  15. Observational
  16. Article
  17. HIV, Sexual Orientation, and Gut Microbiome Interactions.Digestive diseases and sciences · 2020
    Review
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

11 authors at 5 institutions in 1 country.

Ornella SortinoNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.
Kathy Huppler HullsiekLeidos Biomedical Research, Frederick, Maryland.
Elizabeth RichardsNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.
Adam RupertDivision of Infectious Diseases, Department of Medicine, University of Minnesota.
Andrea SchminkeHennepin Healthcare Research Institute, Minneapolis.
Namo TetekporHennepin Healthcare Research Institute, Minneapolis.
Mariam QuinonesNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.
Rachel ProsserHennepin Healthcare Research Institute, Minneapolis.
Tim SchackerLeidos Biomedical Research, Frederick, Maryland.
Irini SeretiNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.
Jason V BakerLeidos Biomedical Research, Frederick, Maryland.
Hennepin Healthcare Research Institute · USLeidos (United States) · USNational Institute of Allergy and Infectious Diseases · USNational Institutes of Health · USUniversity of Minnesota · US

Funding

Immunopathogenic Mechanisms of Human Immunodeficiency Virus (HIV) DiseaseZIAAI001121 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI SERETI, IRINI · 2010 to 2025
$27.2M
NIAID Microbiome ProgramZICAI001233 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI MOUTSOPOULOS, NIKI · 2018 to 2025
$18.9M
CCR NIH HHS HHSN261200800001CNCI NIH HHS HHSN261200800001E
6 · The paper itself

Abstract

Lactoferrin modulates mucosal immunity and targets mechanisms contributing to inflammation during human immunodeficiency virus disease. A randomized placebo-controlled crossover clinical trial of recombinant human (rh) lactoferrin was conducted among 54 human immunodeficiency virus-infected participants with viral suppression. Outcomes were tolerability, inflammatory, and immunologic measures, and the intestinal microbiome. The median age was 51 years, and the median CD4+ cell count was 651/µL. Adherence and adverse events did not differ between rh-lactoferrin and placebo. There was no significant effect on plasma interleukin-6 or D-dimer levels, nor on monocyte/T-cell activation, mucosal integrity, or intestinal microbiota diversity. Oral administration of rh-lactoferrin was safe but did not reduce inflammation and immune activation. Clinical Trials Registration: NCT01830595.

Indexed as

Antiretroviral Therapy, Highly ActiveCD4-Positive T-LymphocytesCross-Over StudiesDouble-Blind MethodFemaleGastrointestinal MicrobiomeHIVHIV InfectionsHumansImmunity, MucosalInflammationInterleukin-6LactoferrinLymphocyte ActivationMaleMiddle AgedInterleukin-6LactoferrinRecombinant Fusion ProteinsHIVimmune activationinflammationlactoferrinmicrobiome

Identifiers

PMID30721997
PMCPMC6784498
OpenAlexW2911566117

What OpenQuestion holds

Textmetadata
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.