Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by National Center for Complementary and Alternative Medicine (NCCAM).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00118872
First received: July 7, 2005
Last updated: December 17, 2009
Last verified: December 2007

July 7, 2005
December 17, 2009
March 2006
Not Provided
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
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: food supplement: Lactobacillus GG
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
January 2008
Not Provided

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
Not Provided
Pakistan
 
NCT00118872
R21 AT001486-01A2, R21AT001486-01A2, Wanke 01
Yes
Not Provided
Purdue University
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