NCT00118872

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2005

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

September 4, 2019

Status Verified

August 1, 2019

Enrollment Period

1.8 years

First QC Date

July 7, 2005

Last Update Submit

August 30, 2019

Conditions

MalnutritionDiarrhea

Keywords

Growth and DevelopmentPakistanWeaningProbioticsInfantLactobacillus GG

Outcome Measures

Primary Outcomes (1)

  • Growth, as measured by weight for age and height

    3 months

Secondary Outcomes (2)

  • Number of episodes of diarrhea

    3 months

  • duration of episodes of diarrhea

    3 months

Study Arms (2)

LGG yogurt

ACTIVE COMPARATOR

Lactobacillus (LGG) containing yogurt

Drug: LGG yogurtOther: Placebo yogurt

Placebo yogurt

PLACEBO COMPARATOR

Regular yogurt, NOT containing LGG

Other: Placebo yogurt

Interventions

LGG yogurtDRUG

Lactobacillus GG containing yogurt

Also known as: Lactobacillus GG containing yogurt
LGG yogurt
Placebo yogurtOTHER

Yogurt NOT containing the active LGG bacteria

LGG yogurtPlacebo yogurt

Eligibility Criteria

Age1 Week - 5 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Malnutrition at time of weaning
  • Medical condition that would affect response to LGG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan Medical Center

Karachi, Pakistan

Location

MeSH Terms

Conditions

MalnutritionDiarrhea

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christine A. Wanke, MD

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2005

First Posted

July 12, 2005

Study Start

March 1, 2006

Primary Completion

December 1, 2007

Study Completion

March 1, 2008

Last Updated

September 4, 2019

Record last verified: 2019-08

Locations

PA(1)