Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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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

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Malnutrition Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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LGG yogurt

Lactobacillus (LGG) containing yogurt

Group Type ACTIVE_COMPARATOR

LGG yogurt

Intervention Type DRUG

Lactobacillus GG containing yogurt

Placebo yogurt

Intervention Type OTHER

Yogurt NOT containing the active LGG bacteria

Placebo yogurt

Regular yogurt, NOT containing LGG

Group Type PLACEBO_COMPARATOR

Placebo yogurt

Intervention Type OTHER

Yogurt NOT containing the active LGG bacteria

Interventions

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LGG yogurt

Lactobacillus GG containing yogurt

Intervention Type DRUG

Placebo yogurt

Yogurt NOT containing the active LGG bacteria

Intervention Type OTHER

Other Intervention Names

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Lactobacillus GG containing yogurt

Eligibility Criteria

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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