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Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants

Feasibility Study of Probiotics for Growth Faltering in Pakistan

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00118872
Enrollment
120
Registered
2005-07-12
Start date
2006-03-31
Completion date
2008-03-31
Last updated
2019-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition, Diarrhea

Keywords

Growth and Development, Pakistan, Weaning, Probiotics, Infant, Lactobacillus GG

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.

Interventions

DRUGLGG yogurt

Lactobacillus GG containing yogurt

Yogurt NOT containing the active LGG bacteria

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Tufts University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Weeks to 5 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Growth, as measured by weight for age and height3 months

Secondary

MeasureTime frame
Number of episodes of diarrhea3 months
duration of episodes of diarrhea3 months

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026