Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants - Full Text View

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

MedlinePlus related topics:

Diarrhea

U.S. FDA Resources

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 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

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators


Principal Investigator:	Christine A. Wanke, MD	Tufts University

More Information

Study ID Numbers:	R21 AT001486-01A2, Wanke 01
First Received:	July 7, 2005
Last Updated:	December 12, 2007
ClinicalTrials.gov Identifier:	NCT00118872
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

Study placed in the following topic categories:

Signs and Symptoms

Diarrhea

Malnutrition

Signs and Symptoms, Digestive

Nutrition Disorders

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00118872