Effect of Lactoferrin in Pneumonia Treatment

June 18, 2022 updated by: Omima mahran hussein, Assiut University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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 .

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with pneumonia who receive only treatment for pneumonia
They receive only treatment for pneumonia
Drug: Pneumonia treatment
Antibiotics for pneumonia
Experimental: pneumonia patients receive treatment for pneumonia and lactoferrin
They receive treatment for pneumonia and lactoferrin
Drug: Pneumonia treatment
Antibiotics for pneumonia
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate.
Time Frame: Up to 8 weeks
Comparing the influence of the intervention on the Survival rate.
Up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in the disease severity (clinical assessment)
Time Frame: Up to 4 weeks
Recording the changes from severe to moderate or mild and the time taken
Up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2022

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

March 12, 2022

First Submitted That Met QC Criteria

June 18, 2022

First Posted (Actual)

June 24, 2022

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 18, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pneumonia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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