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Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants
This study is currently recruiting participants.
Study NCT00118872   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)
First Received: July 7, 2005   Last Updated: December 12, 2007   History of Changes

July 7, 2005
December 12, 2007
March 2006
 
Growth, as measured by weight for age and height
Same as current
Complete list of historical versions of study NCT00118872 on ClinicalTrials.gov Archive Site
  • Number of episodes of diarrhea
  • duration of episodes of diarrhea
Same as current
 
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
Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
  • Malnutrition
  • Diarrhea
Drug: food supplement: Lactobacillus GG
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
January 2008
 

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
 
Pakistan
 
NCT00118872
 
R21 AT001486-01A2, Wanke 01
National Center for Complementary and Alternative Medicine (NCCAM)
 
Principal Investigator: Christine A. Wanke, MD Tufts University
National Center for Complementary and Alternative Medicine (NCCAM)
December 2007

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