Ignite Creation Date:
2024-05-06 @ 12:58 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01696227
Status:
COMPLETED
Last Update Posted:
2014-10-15
First Post:
2012-09-26
Brief Title:
Novel Probiotic Treatment for Prevention of Recurrent UTIs in Children
Sponsor:
Nationwide Childrens Hospital
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
Targeted Pathogen Replacement With Novel Probiotic Treatment for Prevention of Recurrent UTIs in Children
Status:
COMPLETED
Status Verified Date:
2014-10
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:
Nissle 1917
Brief Summary:
Background
Urinary tract infections UTIs are a common and costly cause of doctor visits for children Frequent UTIs trigger kidney damage that leads to serious diseases like high blood pressure pregnancy complications and kidney failure Treating UTIs with preventative antibiotics has not shown improvement of the risk of these diseases and contributes to the growing public health issue of antibiotic resistant bacteria Bacteria that cause UTIs originate from the bowel In an effort to reduce the number of UTIs investigators want to exchange the bacteria living in our bowels for a more harmless variety
Hypothesis and specific aims
Investigators hypothesize a probiotic comprised of a probiotic bacteria will change the bowel bacteria thereby reducing the numbers of infection-causing bacteria thus reducing frequency of UTIs in healthy patients with recurrent UTIs and those patients with urinary tract problems that require use of catheters to empty their bladders
Aim 1 Investigators plan to challenge infection-causing bacteria like Pseudomonas species Enterococcus species and Klebsiella species to live in the same environment with the probiotic bacteria to see how the numbers of each bacteria change
Aim 2 Investigators will culture bacteria that live on urinary catheters and then challenge them to live in the same environment as the probiotic bacteria
Potential Impact
This novel treatment prevents UTIs by exchanging a patients bowel bacteria for a harmless bacteria and reduces the use of antibiotics overall in the community
Urinary tract infections UTIs are a common and costly cause of doctor visits for children Frequent UTIs trigger kidney damage that leads to serious diseases like high blood pressure pregnancy complications and kidney failure Treating UTIs with preventative antibiotics has not shown improvement of the risk of these diseases and contributes to the growing public health issue of antibiotic resistant bacteria Bacteria that cause UTIs originate from the bowel In an effort to reduce the number of UTIs investigators want to exchange the bacteria living in our bowels for a more harmless variety
Hypothesis and specific aims
Investigators hypothesize a probiotic comprised of a probiotic bacteria will change the bowel bacteria thereby reducing the numbers of infection-causing bacteria thus reducing frequency of UTIs in healthy patients with recurrent UTIs and those patients with urinary tract problems that require use of catheters to empty their bladders
Aim 1 Investigators plan to challenge infection-causing bacteria like Pseudomonas species Enterococcus species and Klebsiella species to live in the same environment with the probiotic bacteria to see how the numbers of each bacteria change
Aim 2 Investigators will culture bacteria that live on urinary catheters and then challenge them to live in the same environment as the probiotic bacteria
Potential Impact
This novel treatment prevents UTIs by exchanging a patients bowel bacteria for a harmless bacteria and reduces the use of antibiotics overall in the community
Detailed Description:
None
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