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NCT04432935

Effect of Lactoferrin on Polio Seroconversion

Completed NA Last updated 16 August 2023
What this trial tests

NA trial testing Bovine Lactoferrin in Poliomyelitis in 468 participants. Completed in 30 June 2022.

Timeline
1 October 2020
Primary endpoint
30 June 2022
30 June 2022

Quick facts

Lead sponsorAga Khan University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment468
Start date1 October 2020
Primary completion30 June 2022
Estimated completion30 June 2022
Sites1 location across Pakistan

Drugs / interventions tested

Conditions studied

Sponsor

Aga Khan University

Who can join

Adults 1 Hour to 23 Hours, any sex, with Poliomyelitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A massive decline in cases of poliomyelitis was observed worldwide since 1988; however its transmission continues in Pakistan and Afghanistan. In 2017, a total of 17 cases were reported from these countries, which represent approximately half of the cases reported in 2016. This achievement was made possible by large scale use of oral polio vaccine (OPV) and inactivated polio vaccine (IPV). Despite vigorous efforts to end poliovirus transmission in endemic areas, several challenges including illiteracy, poverty, malnutrition, difficulty to access health and immunization services adversely affect the effectiveness of the polio eradication efforts. Innovations are thus needed to accomplish the goal of eradication as due to limited funding, the sustainability of a program becomes questionable. The aim of this study is to assess the effectiveness of lactoferrin in increasing mucosal and serum immunity in children following administration of poliovirus vaccines.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The effects of orally administered lactoferrin in the prevention and management of viral infections: A systematic review.
    Sinopoli A, Isonne C, Santoro MM, Baccolini V. · · 2022 · cited 26× · PMID 34133812 · DOI 10.1002/rmv.2261
  2. Effect of bovine lactoferrin on seroconversion following polio vaccine administration in children: protocol for a double-blinded randomised controlled trial.
    Habib A, Nausheen S, Nooruddin S, Javed T, et al · · 2022 · PMID 35613782 · DOI 10.1136/bmjopen-2021-050849

Verify or expand the search:

Other trials of Bovine Lactoferrin

Trials testing the same drug.

Other recruiting trials for Poliomyelitis

Currently open trials in the same condition.

Other Aga Khan University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04432935.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing