Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118872
Status:
COMPLETED
Last Update Posted:
2019-09-04
First Post:
2005-07-07
Brief Title:
Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants
Sponsor:
Tufts University
Organization:
Tufts University
Study Overview
Official Title:
Feasibility Study of Probiotics for Growth Faltering in Pakistan
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Wanke 01 | US NIH GrantContract | None | httpsreporternihgovquickSearchR21AT001486 |
| R21AT001486 | NIH | None | None |