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Beneficial Bacteria to Prevent and Malnutrition and Diarrhea in Pakistinian Infants - Article


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Diarrhea

Dysentery


Clinical Trial: Beneficial Bacteria to Prevent and Malnutrition and Diarrhea in Pakistinian Infants

This study is not yet open for patient recruitment.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

This study will determine whether lactobacillus GG (LGG), a beneficial bacterium, 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: Lactobacillus GG

MedlinePlus related topics:  Diarrhea;   Nutrition

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: Feasibility Study of Probiotics for Growth Faltering in Pakistan

Further Study Details: 
Primary Outcomes: Growth, as measured by weight for age and height
Secondary Outcomes: Number of episodes of diarrhea; duration of episodes of diarrhea
Expected Total Enrollment:  100

Study start: September 2005

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

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00118872


Pakistan
      Aga Khan Medical Center, Karachi,  Pakistan
Sajid Soofi, MD  92 21 4930051 
Zulfiqar A. Bhutta, MD, PhD  92 21 4930051  Ext. 4724 
Zulfiqar A. Bhutta, MD, PhD,  Sub-Investigator

Study chairs or principal investigators

Christine A. Wanke, MD,  Principal Investigator,  Tufts University   

More Information

Study ID Numbers:  AT001486-01A2; Wanke 01
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 11, 2005
ClinicalTrials.gov Identifier:  NCT00118872
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26


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July 6, 2008



Page Updated: May 11, 2006
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