Effect of Lactoferrin on Polio Seroconversion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

468 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Randomized, Controlled Trial - Lactoferrin Prevention of Diarrhea in Children

NCT00560222

Diarrhea Malnutrition

COMPLETED PHASE3

Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction

NCT02925026

Environmental Enteric Dysfunction

COMPLETED NA

Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants.

NCT06109688

Urinary Tract Infections in Children

COMPLETED PHASE3

Bovine Lactoferrin and Antibiotic-associated Diarrhoea.

NCT02626104

Antibiotic Associated Diarrhoea

COMPLETED PHASE2

Effectiveness of Multiple Micro-nutrient Fortified Fudge on Nutritional Status of 3-5 Years of Age Children

NCT03450174

Micronutrient Deficiencies Anemia Fortification +2 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Lactoferrin was first discovered in bovine milk which was later isolated in human milk as the second most abundant protein; with high levels found in colostrum. Evidence suggests that Lactoferrin enhances a child's immunity against gastrointestinal infections by inhibiting the growth of bacteria through iron deprivation and by preventing attachment of the virus to the intestinal cells thus children become less susceptible to virus replication in the gut. Investigations of enhanced efficacy of the BCG (Bacillus Calmette-Guérin) vaccine after administration of Lactoferrin showed promising results. The use of bovine Lactoferrin in children is generally recognized as safe by the US Food and Drug Administration. Its anti-infective properties creates a new window of opportunity to assess its effects on the level of seroconversion following poliovirus vaccination in children.

This is a double-blinded two arm randomized placebo-controlled trial. A total of 377 neonates will be enrolled in each group (754 neonates in both groups). Females ages 18-45 years in their last trimester of pregnancy in Karachi, Pakistan will be recruited for the study by the study team and consent will be obtained. Participants will be newborns (on day 1 of birth) who will be followed through 6 months of age. Newborns who fulfill the inclusion criteria will be randomly assigned to the control or intervention group in 1:1 ratio on the first day of birth. Intervention group will receive a daily bovine lactoferrin supplementation whereas Control group will receive a daily placebo supplementation along with breast milk from day 0 of birth to 6 weeks of life. Newborns will be followed up daily during the course of the hospital stay.

After discharge from the hospital, mothers will be provided with a week's supply of lactoferrin or placebo along with instructions on how and when to administer it to the baby. Newborns will be followed up weekly. Compliance will be assessed by counting the used sachets of lactoferrin or placebo because mothers will be instructed to keep the empty sachets in a dedicated container issued by study staff. Mothers will be strictly advised to administer all vaccinations according to the routine immunization schedule. For both groups, a blood sample will be collected in the hospital and containers will be given to the mother for collections of stool for the newborn.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Poliomyelitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group 1:

Bovine lactoferrin (bLF) will be administered (300mg) from day 0 of birth to 6 weeks of life with a single daily dose mixed with milk (preferentially breast milk otherwise premature formula milk).

Group 2:

Placebo will be administered from day 0 of birth to 6 weeks of life. (Placebo will be physically identical to the bLF mixed with breast milk or premature formula milk).

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Randomization will be carried out by Data management unit and all investigators /dispensers and participants will be masked to the randomization.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bovine Lactoferrin

Intervention group will receive bovine lactoferrin supplementation daily once a day from day 0 of birth to 6 weeks of life.

Group Type EXPERIMENTAL

Bovine Lactoferrin

Intervention Type DIETARY_SUPPLEMENT

Lactoferrin is a nutritional supplement which was first discovered in bovine milk which was later isolated in human milk as the second most abundant protein; with high levels found in colostrum. The use of bovine Lactoferrin in children is generally recognized as safe by the US Food and Drug Administration.

Glucon D

Control group will receive Glucon-D supplementation daily once a day from day 0 of birth to 6 weeks of life.

Group Type PLACEBO_COMPARATOR

Placebo Glucon D

Intervention Type OTHER

This group will be given 100mg Glucon-D (99.4% glucose) which will be similar in shape, color to the bLF.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bovine Lactoferrin

Lactoferrin is a nutritional supplement which was first discovered in bovine milk which was later isolated in human milk as the second most abundant protein; with high levels found in colostrum. The use of bovine Lactoferrin in children is generally recognized as safe by the US Food and Drug Administration.

Intervention Type DIETARY_SUPPLEMENT

Placebo Glucon D

This group will be given 100mg Glucon-D (99.4% glucose) which will be similar in shape, color to the bLF.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pregnant females aged 18 to 45 years with no underlying complications or co-morbidities
* Residence less than 30 kms away from the study clinic and have resided there for at least 1 year. Family MUST indicate that they will not move from their current residence for the 5 months after birth of the child (study period)
* Healthy singleton full-term births born to these mothers, regardless of birth weight and an APGAR score of 7 or higher 5 minutes after delivery with no underlying complication (randomization will take place at this stage)

Exclusion Criteria

* Females with health issues and high risk pregnancies
* Neonates presenting with any morbidities and congenital anomalies will be excluded from the study
* Preterm birth (\<37 weeks of gestation)
* Immunodeficiency disorder in immediate family member
* Parents refusing to consent

Minimum Eligible Age

1 Hour

Maximum Eligible Age

23 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes