Effect of Lactoferrin on Polio Seroconversion
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Bovine Lactoferrin; Placebo Glucon D
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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.; This group will be given 100mg Glucon-D (99.4% glucose) which will be similar in shape, color to the bLF.
Intervention MeSH terms: Lactoferrin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Bovine Lactoferrin; Poliovirus; Routine immunization