Effect of Lactoferrin on Polio Seroconversion
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| ClinicalTrials.gov Identifier: NCT04432935 |
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Recruitment Status :
Recruiting
First Posted : June 16, 2020
Last Update Posted : April 19, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Poliomyelitis | Dietary Supplement: Bovine Lactoferrin Other: Placebo Glucon D | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 754 participants |
| 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) |
| Masking Description: | Randomization will be carried out by Data management unit and all investigators /dispensers and participants will be masked to the randomization. |
| Primary Purpose: | Prevention |
| Official Title: | Effect of Bovine Lactoferrin on Seroconversion Following Polio Vaccine Administration in Children: A Randomized Control Trial |
| Actual Study Start Date : | October 1, 2020 |
| Estimated Primary Completion Date : | June 30, 2022 |
| Estimated Study Completion Date : | June 30, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Bovine Lactoferrin
Intervention group will receive bovine lactoferrin supplementation daily once a day from day 0 of birth to 6 weeks of life.
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Dietary Supplement: 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. |
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Placebo Comparator: Glucon D
Control group will receive Glucon-D supplementation daily once a day from day 0 of birth to 6 weeks of life.
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Other: Placebo Glucon D
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 [ Time Frame: 10 weeks ]Presence of detectable antibodies to poliovirus types 1 and 3 in serum) after receipt of two doses of OPV
- Comparison of humoral immunity represented by seroconversion [ Time Frame: 18 weeks ]Presence of detectable antibodies to poliovirus types 1, 2 and 3 in serum) after completion of the routine immunization doses/schedule
- Comparison of intestinal immunity represented by shedding of poliovirus types 1 and 3 [ Time Frame: 19 weeks ]If lactoferrin is effective in improving intestinal immunity, shedding is expected to be lower in the lactoferrin receiving group.
- Comparison of duration of shedding among the two study arms [ Time Frame: 20 and 22 weeks ]Represented by shedding at 20 weeks of age and at 22 weeks of age after the challenge dose of bOPV administered
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| Ages Eligible for Study: | 1 Hour to 23 Hours (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04432935
| Contact: Muhammad Atif Habib, MBBS, PhD | +922134829538 ext 8049 | atif.habib@aku.edu | |
| Contact: Shanila Nooruddin, MBBS, MS | +922134829538 ext 8045 | shanila.nooruddin@aku.edu |
| Pakistan | |
| Kharadar Campus, Aga Khan University Hospital | Recruiting |
| Karachi, Pakistan, 74800 | |
| Contact: Sajid B Soofi, FCPS +923002769398 sajid.soofi@aku.edu | |
| Contact: sidrah nausheen, FCPS 923012338464 sidrah.nausheen@aku.edu | |
| Principal Investigator: | Sajid Soofi, MBBS, FCPS | Aga Khan University |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr Sajid Bashir Soofi, Associate Professor, Aga Khan University |
| ClinicalTrials.gov Identifier: | NCT04432935 |
| Other Study ID Numbers: |
2019-1955-5013 |
| First Posted: | June 16, 2020 Key Record Dates |
| Last Update Posted: | April 19, 2022 |
| Last Verified: | April 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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 Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Bovine Lactoferrin Poliovirus Routine immunization |
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Poliomyelitis Myelitis Central Nervous System Infections Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Virus Diseases Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases Lactoferrin Anti-Infective Agents |