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NCT05431023 Clinical Trial

Effect of Lactoferrin in Pneumonia Treatment

Pneumonia Clinical Trial

Official title:
Efficacy of Lactoferrin as Adjunct Therapy for Pneumonia in Children and Adolescents

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05431023
Other study ID # Pneumonia
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2022
Est. completion date August 1, 2024

Study information
Verified date June 2022
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pneumonia is defind as the inflammation of lung tissue caused by an infectious agent that results in acute respiratory signs and symptoms. Community acquired pneumonia (CAP) is a major cause of morbidity and increased health care costs. In developing nations, pneumonia remains a significant cause of mortality in children. Pneumonia occurs in 30 to 45 of every 1,000 children under 5 years of age; it is less common in 5- to 9-year olds (16 to 22/1,000) and in older children (7 to 16/1,000). Streptococcus pneumoniae is the primary bacterial cause of pneumonia in infants and children. Viral etiologies become less prevalent and mycoplasmal and chlamydial infections become more prevalent with increasing age

Description:

Lactoferrin (LF) is iron-binding glycoprotein of the transferrin family that is expressed and secreted by glandular cells and is found in most body fluids . It appears at especially high concentrations in mammalian milk and was first identified in bovine milk , and was subsequently isolated from human milk. LFs bacteriostatic function is due to its ability to take up the Fe3+ ion, limiting use of this nutrient by bacteria at the infection site and inhibiting the growth of these microorganisms as well as the expression of their virulence factors .

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 72
Est. completion date August 1, 2024
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Month to 18 Years
Eligibility Inclusion Criteria: - Pneumonia patients - from the age of one month to the age of 18 years . Exclusion Criteria: Neonates and any children with : - immune deficiency - congenital heart disease - neuromascular disorder - genetic syndromes

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lactoferrin
Lactoferrin binds to and blocks glycosaminoglycan viral receptors, especially heparan sulfate (HS). The binding of LF and HS prevents the first contact between virus and host cell and therefore prevents the infection
• Pneumonia treatment
Antibiotics for pneumonia

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Outcome
Type Measure Description Time frame Safety issue
Primary Survival rate. Comparing the influence of the intervention on the Survival rate. Up to 8 weeks
Secondary Mean change in the disease severity (clinical assessment) Recording the changes from severe to moderate or mild and the time taken Up to 4 weeks
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