Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants
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|ClinicalTrials.gov Identifier: NCT00118872|
Recruitment Status : Completed
First Posted : July 12, 2005
Last Update Posted : December 23, 2014
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||Phase|
|Malnutrition Diarrhea||Drug: LGG yogurt Other: Placebo yogurt||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study of Probiotics for Growth Faltering in Pakistan|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||March 2008|
Active Comparator: LGG yogurt
Lactobacillus (LGG) containing yogurt
Drug: LGG yogurt
Lactobacillus GG containing yogurt
Other Name: Lactobacillus GG containing yogurtOther: Placebo yogurt
Yogurt NOT containing the active LGG bacteria
Placebo Comparator: Placebo yogurt
Regular yogurt, NOT containing LGG
- Growth, as measured by weight for age and height [ Time Frame: 3 months ]
- Number of episodes of diarrhea [ Time Frame: 3 months ]
- duration of episodes of diarrhea [ Time Frame: 3 months ]
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|
|Principal Investigator:||Christine A. Wanke, MD||Tufts University|