Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Feasibility Study of Probiotics for Growth Faltering in Pakistan|
- Growth, as measured by weight for age and height [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||March 2006|
|Study Completion Date:||March 2008|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Active Comparator: LGG yogurt
Lactobacillus (LGG) containing yogurt
Drug: LGG yogurt
Lactobacillus GG containing yogurt
Other Name: Lactobacillus GG containing yogurtOther: Placebo yogurt
Yogurt NOT containing the active LGG bacteria
Placebo Comparator: Placebo yogurt
Regular yogurt, NOT containing LGG
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118872
|Aga Khan Medical Center|
|Principal Investigator:||Christine A. Wanke, MD||Tufts University|