Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by National Center for Complementary and Alternative Medicine (NCCAM).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00118872
First received: July 7, 2005
Last updated: December 17, 2009
Last verified: December 2007
  Purpose

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
Malnutrition
Diarrhea
Drug: food supplement: Lactobacillus GG

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Growth, as measured by weight for age and height

Secondary Outcome Measures:
  • Number of episodes of diarrhea
  • duration of episodes of diarrhea

Estimated Enrollment: 100
Study Start Date: March 2006
Estimated Study Completion Date: January 2008
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.

  Eligibility

Ages Eligible for Study:   up to 5 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118872

Locations
Pakistan
Aga Khan Medical Center Recruiting
Karachi, Pakistan
Contact: Sajid Soofi, MD    92 21 4930051    sajid.soofi@aku.edu   
Contact: Zulfiqar A. Bhutta, MD, PhD    92 21 4930051 ext 4724    zulfiqar.bhutta@aku.edu   
Sub-Investigator: Zulfiqar A. Bhutta, MD, PhD         
Sponsors and Collaborators
Purdue University
Investigators
Principal Investigator: Christine A. Wanke, MD Tufts University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00118872     History of Changes
Other Study ID Numbers: R21 AT001486-01A2, R21AT001486-01A2, Wanke 01
Study First Received: July 7, 2005
Last Updated: December 17, 2009
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Growth and Development
Pakistan
Weaning
Probiotics
Infant
Lactobacillus GG

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

ClinicalTrials.gov processed this record on April 15, 2014