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Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Christine A. Wanke, National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00118872
First received: July 7, 2005
Last updated: December 22, 2014
Last verified: December 2007

July 7, 2005
December 22, 2014
March 2006
December 2007   (final data collection date for primary outcome measure)
Growth, as measured by weight for age and height [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Growth, as measured by weight for age and height
Complete list of historical versions of study NCT00118872 on ClinicalTrials.gov Archive Site
  • Number of episodes of diarrhea [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • duration of episodes of diarrhea [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of episodes of diarrhea
  • duration of episodes of diarrhea
Not Provided
Not Provided
 
Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants
Feasibility Study of Probiotics for Growth Faltering in Pakistan

This study will determine whether lactobacillus GG (LGG), a beneficial bacterium, when given in yogurt, will reduce growth faltering in babies living in a poor area of Pakistan who are being weaned from breastfeeding.

Study hypothesis: Use of the probiotic bacteria LGG at the time of weaning will lessen the impact of faltering growth in babies living in the slums of Pakistan.

Faltering growth due to malnutrition and recurrent diarrhea is a serious public health concern in developing nations, particularly among infants who are being weaned from breastfeeding. Evidence suggests that the use of the probiotic bacterium LGG reduces the risk of diarrhea, shortens episodes of diarrhea, and enhances the immune system. Babies who are being weaned from breastfeeding will be given LGG-containing yogurt in this study to determine whether LGG will reduce faltering growth caused by diarrhea and malnutrition.

Infant participants will be enrolled at or within 5 weeks of birth and followed throughout the weaning period. During the weaning period, participants will be randomly assigned to either receive LGG-containing yogurt or placebo yogurt everyday for 3 months. All participants will have height and weight measurements taken at study entry and at Month 3 (study completion). The number of diarrhea episodes experienced by participants during the study will be assessed at study completion to determine participants' health.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Malnutrition
  • Diarrhea
  • Drug: LGG yogurt
    Lactobacillus GG containing yogurt
    Other Name: Lactobacillus GG containing yogurt
  • Other: Placebo yogurt
    Yogurt NOT containing the active LGG bacteria
  • Active Comparator: LGG yogurt
    Lactobacillus (LGG) containing yogurt
    Interventions:
    • Drug: LGG yogurt
    • Other: Placebo yogurt
  • Placebo Comparator: Placebo yogurt
    Regular yogurt, NOT containing LGG
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
March 2008
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Born and reside in Bilal Colony, Karachi Pakistan during the study
  • Parent or guardian willing to provide informed consent
  • Parent or guardian willing to permit home visits
  • Predominantly breastfed at study start

Exclusion Criteria:

  • Malnutrition at time of weaning
  • Medical condition that would affect response to LGG
Both
up to 5 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT00118872
R21 AT001486-01A2, R21AT001486-01A2, Wanke 01
Yes
Christine A. Wanke, National Center for Complementary and Alternative Medicine (NCCAM)
Tufts University
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Christine A. Wanke, MD Tufts University
Tufts University
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP