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OpenTrials
Completed

NCT Number: NCT00118872

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.

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Key information

Age range

1 week–5 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan Medical Center

Karachi, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LGG yogurt

Drug

Lactobacillus GG containing yogurt

Other names: Lactobacillus GG containing yogurt

Placebo yogurt

Other

Yogurt NOT containing the active LGG bacteria

Primary outcomes

  1. Growth, as measured by weight for age and height

    Time frame: 3 months

Secondary outcomes

  1. Number of episodes of diarrhea

    Time frame: 3 months

  2. duration of episodes of diarrhea

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Feasibility Study of Probiotics for Growth Faltering in Pakistan

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Jul 12, 2005
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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