NCT00560222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
555

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 1, 2011

Status Verified

October 1, 2011

Enrollment Period

3.2 years

First QC Date

November 15, 2007

Last Update Submit

October 31, 2011

Conditions

DiarrheaMalnutrition

Keywords

randomized controlled triallactoferrinchildrendiarrheamalnutritiongrowth

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (1)

  • Determination of the effect of bovine lactoferrin supplementation on growth.

    6 months

Study Arms (2)

A

ACTIVE COMPARATOR

This group will receive daily lactoferrin supplementation

Dietary Supplement: bovine lactoferrin

B

PLACEBO COMPARATOR

placebo

Dietary Supplement: placebo [maltodextrin]

Interventions

bovine lactoferrinDIETARY_SUPPLEMENT

1gm of lactoferrin will be given each day

A
placebo [maltodextrin]DIETARY_SUPPLEMENT

placebo that appears identical to lactoferrin will be given daily

B

Eligibility Criteria

Age12 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Peruana Cayetana Heredia

Lima, Peru

Location

Related Publications (7)

  • 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.

    PMID: 15384625BACKGROUND

  • 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.

    PMID: 12933858BACKGROUND

  • 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.

    PMID: 16936809BACKGROUND

  • 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.

    PMID: 12508150BACKGROUND

  • 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.

    PMID: 12438385BACKGROUND

  • 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.

    PMID: 11787716BACKGROUND

  • 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.

    PMID: 22939927DERIVED

MeSH Terms

Conditions

DiarrheaMalnutrition

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Thomas G Cleary, MD

    University of Texas School of Public Health - Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Division of Epidemiology

Study Record Dates

First Submitted

November 15, 2007

First Posted

November 19, 2007

Study Start

February 1, 2008

Primary Completion

May 1, 2011

Study Completion

October 1, 2011

Last Updated

November 1, 2011

Record last verified: 2011-10

Locations

PE(1)