NCT00118872

Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants

Feasibility Study of Probiotics for Growth Faltering in Pakistan

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Tufts University · Academic / Other
• Sex: All
• Age: 1 Week – 5 Weeks
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Malnutrition
• Diarrhea

Interventions

Type	Name	Description
DRUG	LGG yogurt	Lactobacillus GG containing yogurt
OTHER	Placebo yogurt	Yogurt NOT containing the active LGG bacteria

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-12-01
• Completion: 2008-03-01
• First posted: 2005-07-12
• Last updated: 2019-09-04

Locations

1 site across 1 country: Pakistan