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Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00118872
Recruitment Status : Completed
First Posted : July 12, 2005
Last Update Posted : December 23, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Malnutrition Diarrhea Drug: LGG yogurt Other: Placebo yogurt

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasibility Study of Probiotics for Growth Faltering in Pakistan
Study Start Date : March 2006
Primary Completion Date : December 2007
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

Secondary Outcome Measures :
  1. Number of episodes of diarrhea [ Time Frame: 3 months ]
  2. duration of episodes of diarrhea [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)
ClinicalTrials.gov Identifier: NCT00118872     History of Changes
Other Study ID Numbers: R21AT001486-01A2 ( U.S. NIH Grant/Contract )
Wanke 01
First Posted: July 12, 2005    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2007

Keywords provided by Christine A. Wanke, National Center for Complementary and Alternative Medicine (NCCAM):
Growth and Development
Lactobacillus GG

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Nutrition Disorders