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Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants

Primary Purpose

Malnutrition, Diarrhea

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
LGG yogurt
Placebo yogurt
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition focused on measuring Growth and Development, Pakistan, Weaning, Probiotics, Infant, Lactobacillus GG

Eligibility Criteria

1 Week - 5 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aga Khan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

LGG yogurt

Placebo yogurt

Arm Description

Lactobacillus (LGG) containing yogurt

Regular yogurt, NOT containing LGG

Outcomes

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

Full Information

First Posted
July 7, 2005
Last Updated
August 30, 2019
Sponsor
Tufts University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00118872
Brief Title
Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants
Official Title
Feasibility Study of Probiotics for Growth Faltering in Pakistan
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Diarrhea
Keywords
Growth and Development, Pakistan, Weaning, Probiotics, Infant, Lactobacillus GG

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LGG yogurt
Arm Type
Active Comparator
Arm Description
Lactobacillus (LGG) containing yogurt
Arm Title
Placebo yogurt
Arm Type
Placebo Comparator
Arm Description
Regular yogurt, NOT containing LGG
Intervention Type
Drug
Intervention Name(s)
LGG yogurt
Other Intervention Name(s)
Lactobacillus GG containing yogurt
Intervention Description
Lactobacillus GG containing yogurt
Intervention Type
Other
Intervention Name(s)
Placebo yogurt
Intervention Description
Yogurt NOT containing the active LGG bacteria
Primary Outcome Measure Information:
Title
Growth, as measured by weight for age and height
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of episodes of diarrhea
Time Frame
3 months
Title
duration of episodes of diarrhea
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
5 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine A. Wanke, MD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan Medical Center
City
Karachi
Country
Pakistan

12. IPD Sharing Statement

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Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants

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