An interventional study of Bovine Lactoferrin and Placebo Glucon D in Poliomyelitis, sponsored by Aga Khan University. Completed at 1 site in Pakistan. Open to participants aged 1 Hour to 23 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-16.
Sponsored by Aga Khan University · Not applicable, Interventional, and Prevention
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 13 studies in Poliomyelitis by Aga Khan University — none open to participants now, none under way, none of them phase 3. Poliomyelitis · Aga Khan University.
Among the 13 studies in Poliomyelitis by Aga Khan University, this one is the 10th largest by enrollment, is one of 2 that started in 2020, is one of 9 with no phase, and was the 11th registered.
274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.
Browse Poliomyelitis studies →None of the 13 studies in Poliomyelitis by Aga Khan University is open now. The open studies under Poliomyelitis, anywhere →
Of the 11 Poliomyelitis studies recruiting now, none (0%) set no upper age limit and 11 (100%) stop at 75 or younger; 10 take children under 18; 11 take healthy volunteers.
This study: 1 Hour to 23 Hours · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 2 started in 2020.
This study's enrollment of 468 is close to the median of 476 across 249 interventional studies indexed under Poliomyelitis.
Median enrollment 840 across the 13 interventional studies. Of the 8 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Aga Khan University is the lead sponsor of 294 studies on the registry; 43 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Poliomyelitis by Aga Khan University, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intervention group will receive bovine lactoferrin supplementation daily once a day from day 0 of birth to 6 weeks of life.
Dietary Supplement: Bovine Lactoferrin
Control group will receive Glucon-D supplementation daily once a day from day 0 of birth to 6 weeks of life.
Other: Placebo Glucon D
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.
Assessment of humoral immunity by seroconversion
Presence of detectable antibodies to poliovirus types 1 and 3 in serum) after receipt of two doses of OPV
Time frame: 10 weeks
Comparison of humoral immunity represented by seroconversion
Presence of detectable antibodies to poliovirus types 1, 2 and 3 in serum) after completion of the routine immunization doses/schedule
Time frame: 18 weeks
Comparison of intestinal immunity represented by shedding of poliovirus types 1 and 3
If lactoferrin is effective in improving intestinal immunity, shedding is expected to be lower in the lactoferrin receiving group.
Time frame: 19 weeks
Comparison of duration of shedding among the two study arms
Represented by shedding at 20 weeks of age and at 22 weeks of age after the challenge dose of bOPV administered
Time frame: 20 and 22 weeks
Plan to share: Yes — Study findings will be disseminated through presentations at scientific conferences and educational practice workshops and will be published in an international peer-reviewed scientific journal.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: After the manuscript has been prepared and published.
Access criteria: A formal application to the PI will be required requesting him about the accessibility of the data. This should include the rationale and expected use of the study data.
Ran from Oct 2020 to primary completion in Jun 2022, 20 months.
Of 16 interventional studies with no phase under Poliomyelitis, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 22. This study's 20 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Lactoferrin, bovine