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Randomized, Controlled Trial - Lactoferrin Prevention of Diarrhea in Children

Primary Purpose

Diarrhea, Malnutrition

Status
Completed
Phase
Phase 3
Locations
Peru
Study Type
Interventional
Intervention
bovine lactoferrin
placebo [maltodextrin]
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhea focused on measuring randomized controlled trial, lactoferrin, children, diarrhea, malnutrition, growth

Eligibility Criteria

12 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Infants 12 to 18 months of age from the Outpatient clinics (Puestos de Salud) of Districto de Independencia in Lima, Peru will be eligible for enrollment in this study.
  2. Infants previously weaned for at least one week will be eligible for study.

Exclusion Criteria:

  1. Infants with either exclusive or partial breast-feeding will not be enrolled; mothers will be encouraged to continue breastfeeding.
  2. Infants ill with severe, persistent or chronic diarrhea will be excluded.
  3. Infants with severe malnutrition (defined as weight-for-height < -3 SDs, height-for-age < -3SDs)will be excluded.
  4. Infants with a serious infections that required hospitalization 1 month prior (e.g. meningitis,pneumonia, bacteremia) will be excluded.
  5. Infants with known HIV (data from parent or medical records) will be excluded.
  6. Infants with underlying chronic illness (e.g. malignancy, immunosuppression, chronic renal failure, congestive heart failure, liver failure) will be excluded.
  7. Infants with history of allergy to cow's milk or infant formula, eczema, allergic rhinitis or asthma will be excluded.
  8. Infants with a family history of eczema, allergic rhinitis, asthma, or milk intolerance will be excluded.

Sites / Locations

  • Universidad Peruana Cayetana Heredia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

This group will receive daily lactoferrin supplementation

placebo

Outcomes

Primary Outcome Measures

Determination of the effect of bovine lactoferrin supplementation on prevention of diarrhea,measured by the number of episodes of diarrhea during a 6 month trial in previously weaned Peruvian children enrolled at 12 to 18 months of age.

Secondary Outcome Measures

Determination of the effect of bovine lactoferrin supplementation on growth.

Full Information

First Posted
November 15, 2007
Last Updated
October 31, 2011
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00560222
Brief Title
Randomized, Controlled Trial - Lactoferrin Prevention of Diarrhea in Children
Official Title
Randomized, Controlled Trial - Lactoferrin Prevention of Diarrhea in Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Much has been learned in recent years about the mechanisms by which breastfeeding improves child health and survival. However, there has been little progress in using these insights to improve pediatric care. Factors that are important for protecting the breast fed infant might be expected to decrease the adverse effects of weaning on diarrhea, growth, and development. The proposed study is meant to begin addressing this important gap by a clinical trial of lactoferrin supplementation in previously weaned children. Lactoferrin,an iron-binding protein with multiple physiological functions (anti-microbial, anti-inflammatory, and immunomodulatory), is one of the most important proteins present in mammalian milk. Our hypothesis is that lactoferrin (given as a daily supplement in amounts similar to those consumed if the child were still breastfed) will improve health by mimicking its protective roles in milk. The significance of these studies is that they will prove feasibility of improving child health after the end of breastfeeding by continuing ingestion of a major protective milk protein. Diarrhea and malnutrition after weaning is a global problem that may be amenable to this approach.
Detailed Description
The proposed community-based study will be conducted in a previously weaned population at risk for repeated intestinal infections. Infants who are 12-18 months of age living in the District of Independencia, Lima, Peru will be eligible for enrollment. We will conduct a randomized double blind placebo controlled trial comparing twice daily supplementation with bovine lactoferrin versus a placebo (maltodextrin) Therapy will be continued for 6 months with close monitoring of all study participants for diarrhea and growth. Specific aim 1: Determine the effect of bovine lactoferrin supplementation on prevention of diarrhea,measured by the number of episodes of diarrhea during a 6 month trial in previously weaned Peruvian children enrolled at 12 to 18 months of age. Specific aim 2: Determine the effect of bovine lactoferrin supplementation on growth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Malnutrition
Keywords
randomized controlled trial, lactoferrin, children, diarrhea, malnutrition, growth

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
555 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
This group will receive daily lactoferrin supplementation
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
bovine lactoferrin
Intervention Description
1gm of lactoferrin will be given each day
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo [maltodextrin]
Intervention Description
placebo that appears identical to lactoferrin will be given daily
Primary Outcome Measure Information:
Title
Determination of the effect of bovine lactoferrin supplementation on prevention of diarrhea,measured by the number of episodes of diarrhea during a 6 month trial in previously weaned Peruvian children enrolled at 12 to 18 months of age.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Determination of the effect of bovine lactoferrin supplementation on growth.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Infants 12 to 18 months of age from the Outpatient clinics (Puestos de Salud) of Districto de Independencia in Lima, Peru will be eligible for enrollment in this study. Infants previously weaned for at least one week will be eligible for study. Exclusion Criteria: Infants with either exclusive or partial breast-feeding will not be enrolled; mothers will be encouraged to continue breastfeeding. Infants ill with severe, persistent or chronic diarrhea will be excluded. Infants with severe malnutrition (defined as weight-for-height < -3 SDs, height-for-age < -3SDs)will be excluded. Infants with a serious infections that required hospitalization 1 month prior (e.g. meningitis,pneumonia, bacteremia) will be excluded. Infants with known HIV (data from parent or medical records) will be excluded. Infants with underlying chronic illness (e.g. malignancy, immunosuppression, chronic renal failure, congestive heart failure, liver failure) will be excluded. Infants with history of allergy to cow's milk or infant formula, eczema, allergic rhinitis or asthma will be excluded. Infants with a family history of eczema, allergic rhinitis, asthma, or milk intolerance will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas G Cleary, MD
Organizational Affiliation
University of Texas School of Public Health - Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Peruana Cayetana Heredia
City
Lima
Country
Peru

12. IPD Sharing Statement

Citations:
PubMed Identifier
15384625
Citation
Ochoa TJ, Noguera-Obenza M, Cleary TG. Lactoferrin blocks the initial host cell attachment mechanism of Enteropathogenic E. coli (EPEC). Adv Exp Med Biol. 2004;554:463-6. doi: 10.1007/978-1-4757-4242-8_65. No abstract available.
Results Reference
background
PubMed Identifier
12933858
Citation
Ochoa TJ, Noguera-Obenza M, Ebel F, Guzman CA, Gomez HF, Cleary TG. Lactoferrin impairs type III secretory system function in enteropathogenic Escherichia coli. Infect Immun. 2003 Sep;71(9):5149-55. doi: 10.1128/IAI.71.9.5149-5155.2003.
Results Reference
background
PubMed Identifier
16936809
Citation
Ochoa TJ, Brown EL, Guion CE, Chen JZ, McMahon RJ, Cleary TG. Effect of lactoferrin on enteroaggregative E. coli (EAEC). Biochem Cell Biol. 2006 Jun;84(3):369-76. doi: 10.1139/o06-053.
Results Reference
background
PubMed Identifier
12508150
Citation
Gomez HF, Ochoa TJ, Carlin LG, Cleary TG. Human lactoferrin impairs virulence of Shigella flexneri. J Infect Dis. 2003 Jan 1;187(1):87-95. doi: 10.1086/345875. Epub 2002 Dec 13.
Results Reference
background
PubMed Identifier
12438385
Citation
Gomez HF, Ochoa TJ, Herrera-Insua I, Carlin LG, Cleary TG. Lactoferrin protects rabbits from Shigella flexneri-induced inflammatory enteritis. Infect Immun. 2002 Dec;70(12):7050-3. doi: 10.1128/IAI.70.12.7050-7053.2002.
Results Reference
background
PubMed Identifier
11787716
Citation
Gomez HF, Herrera-Insua I, Siddiqui MM, Diaz-Gonzalez VA, Caceres E, Newburg DS, Cleary TG. Protective role of human lactoferrin against invasion of Shigella flexneri M90T. Adv Exp Med Biol. 2001;501:457-67. doi: 10.1007/978-1-4615-1371-1_57.
Results Reference
background
PubMed Identifier
22939927
Citation
Ochoa TJ, Chea-Woo E, Baiocchi N, Pecho I, Campos M, Prada A, Valdiviezo G, Lluque A, Lai D, Cleary TG. Randomized double-blind controlled trial of bovine lactoferrin for prevention of diarrhea in children. J Pediatr. 2013 Feb;162(2):349-56. doi: 10.1016/j.jpeds.2012.07.043. Epub 2012 Aug 30.
Results Reference
derived

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Randomized, Controlled Trial - Lactoferrin Prevention of Diarrhea in Children

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