Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants

Malnutrition Clinical Trial

Official title:

Feasibility Study of Probiotics for Growth Faltering in Pakistan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118872
• Other study ID #: R21AT001486-01A2
• Secondary ID: R21AT001486Wanke
• Status: Completed
• Phase: N/A
• Start date: March 2006
• Est. completion date: March 2008

Study information

• Verified date: August 2019
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea
• Malnutrition

Intervention

Drug:
• LGG yogurt
Lactobacillus GG containing yogurt

Other:
• Placebo yogurt
Yogurt NOT containing the active LGG bacteria

Locations

Country	Name	City	State
Pakistan	Aga Khan Medical Center	Karachi

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth, as measured by weight for age and height		3 months
Secondary	Number of episodes of diarrhea		3 months
Secondary	duration of episodes of diarrhea		3 months