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Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants

This study has been completed.
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Christine A. Wanke, National Center for Complementary and Alternative Medicine (NCCAM) Identifier:
First received: July 7, 2005
Last updated: December 22, 2014
Last verified: December 2007

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.

Condition Intervention
Drug: LGG yogurt
Other: Placebo yogurt

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Feasibility Study of Probiotics for Growth Faltering in Pakistan

Resource links provided by NLM:

Further study details as provided by Tufts University:

Primary Outcome Measures:
  • Growth, as measured by weight for age and height [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Number of episodes of diarrhea [ Time Frame: 3 months ]
  • duration of episodes of diarrhea [ Time Frame: 3 months ]

Enrollment: 120
Study Start Date: March 2006
Study Completion Date: March 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LGG yogurt
Lactobacillus (LGG) containing yogurt
Drug: LGG yogurt
Lactobacillus GG containing yogurt
Other Name: Lactobacillus GG containing yogurt
Other: Placebo yogurt
Yogurt NOT containing the active LGG bacteria
Placebo Comparator: Placebo yogurt
Regular yogurt, NOT containing LGG

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.


Ages Eligible for Study:   up to 5 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00118872

Aga Khan Medical Center
Karachi, Pakistan
Sponsors and Collaborators
Tufts University
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Christine A. Wanke, MD Tufts University
  More Information

Responsible Party: Christine A. Wanke, Assistant Professor, National Center for Complementary and Alternative Medicine (NCCAM) Identifier: NCT00118872     History of Changes
Other Study ID Numbers: R21AT001486-01A2 ( US NIH Grant/Contract Award Number )
Wanke 01
Study First Received: July 7, 2005
Last Updated: December 22, 2014

Keywords provided by Tufts University:
Growth and Development
Lactobacillus GG

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Nutrition Disorders processed this record on May 25, 2017