Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants

Not Applicable

Completed

• Conditions: Malnutrition; Diarrhea
• Interventions: Drug: LGG yogurt; Other: Placebo yogurt

• Registration Number: NCT00118872
• Lead Sponsor: Tufts University

Brief 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.

Study Timeline

• Study First Submitted: 2005-07-07
• Study First Submitted QC: 2005-07-07
• Study First Posted: 2005-07-12
• Study Start: 2006-03
• Primary Completion: 2007-12
• Study Completion: 2008-03
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-30
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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Exclusion Criteria

• Malnutrition at time of weaning
• Medical condition that would affect response to LGG

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LGG yogurt	LGG yogurt	Lactobacillus (LGG) containing yogurt
LGG yogurt	Placebo yogurt	Lactobacillus (LGG) containing yogurt
Placebo yogurt	Placebo yogurt	Regular yogurt, NOT containing LGG

Primary Outcome Measures

Name	Time	Method
Growth, as measured by weight for age and height	3 months

Secondary Outcome Measures

Name	Time	Method
Number of episodes of diarrhea	3 months
duration of episodes of diarrhea	3 months

Trial Locations

Locations (1)

Aga Khan Medical Center; 🇵🇰 Karachi, Pakistan