Ignite Creation Date:
2024-05-05 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00767988
Status:
WITHDRAWN
Last Update Posted:
2015-09-15
First Post:
2008-10-06
Brief Title:
Probiotics in Girls With Spina Bifida
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Probiotics Improvement of Gastrointestinal and Genitourinary Health in Girls With Spina Bifida H-23245
Status:
WITHDRAWN
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn by PI
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Girls with spina bifida also have bladder problems This is because they need temporary placement of a tube into the bladder to remove urine This thin flexible tube is called a catheter It can increase the risk of having bacteria in the urine This in turn can lead to urinary tract infection UTI
Some girls with spina bifida are given antibiotics These are medicines used to treat infections caused by bacteria The medicine is used to prevent UTI However long-term treatment with these medicines can have side effects For example the bacteria may become resistant to the antibiotics Also bacteria in the urine can persist UTI can still occur in patients on antibiotics
UTI in girls occurs because bacteria migrate from the rectum to the vagina area This gives the bacteria access to the bladder Also in girls with spina bifida the access to the bladder is easier because of the catheter
Probiotics are friendly bacteria They are available as dietary supplements and as food They contain helpful bacteria Yogurt is an example of a food that contains probiotics
The purpose of this study is to find out if probiotics taken for 6 months can prevent UTI in girls with spina bifida We will also try to find out whether changes in urine bacteria are associated with the taking of the probiotics A vaginal and rectal swab will also be done to find out if taking probiotics has any benefits on preventing bacteria
Some girls with spina bifida are given antibiotics These are medicines used to treat infections caused by bacteria The medicine is used to prevent UTI However long-term treatment with these medicines can have side effects For example the bacteria may become resistant to the antibiotics Also bacteria in the urine can persist UTI can still occur in patients on antibiotics
UTI in girls occurs because bacteria migrate from the rectum to the vagina area This gives the bacteria access to the bladder Also in girls with spina bifida the access to the bladder is easier because of the catheter
Probiotics are friendly bacteria They are available as dietary supplements and as food They contain helpful bacteria Yogurt is an example of a food that contains probiotics
The purpose of this study is to find out if probiotics taken for 6 months can prevent UTI in girls with spina bifida We will also try to find out whether changes in urine bacteria are associated with the taking of the probiotics A vaginal and rectal swab will also be done to find out if taking probiotics has any benefits on preventing bacteria
Detailed Description:
In children with spina bifida and neurogenic bladder dysfunction the need for intermittent bladder catheterization increases the risk of bacteriuria In many patients this leads to a clinically significant urinary tract infection UTI Many of these children are placed on long term low dose antibiotic suppression to prevent recurrent urinary infection Unfortunately bacteriuria often persists despite daily antibiotic therapy and breakthrough UTIs are common Furthermore this approach carries the potential for deleterious side effects and may promote the development of antibiotic-resistant bacteria
UTI in girls occur when virulent bacteria migrate from the rectum and colonize the vagina and peri-urethral mucosa thus gaining access to the bladder In girls with spina bifida access to the bladder is greatly facilitated by catheter passage Antibiotic prophylaxis relies on maintaining a low dose of antibiotic in the urinary stream which decreases peri-urethral colonization and prevents proliferation of bacteria after they gain access to the bladder An alternative approach to daily antibiotic prophylaxis is to decrease the risk of urinary colonization with virulent bacteria by supplementing the normal bacteria flora with non-infection causing strains of bacteria
Probiotics are dietary supplements containing potentially beneficial bacterial strains such as Lactobacillus The safety of oral administration of probiotics has been demonstrated in several studies over the last 30 years Studies using Lactobacillus rhamnosus GG a probiotic introduced in the late 1980s to alleviate diarrhea have shown promising results when used for UTI prevention In one study researchers found that the subjects consuming GG drinks had fewer episodes of UTI compared to those women not receiving probiotics A placebo-controlled study in premature infants also used GG in an attempt to prevent UTI The number of urinary infections was reduced but statistically the difference was not significant Finally a recent randomized clinical trial demonstrated that the rate of UTI in children taking prophylactic antibiotics was similar to that of patients taking Lactobacillus acidophilus alone The efficacy of probiotic usage in the spina bifida population has not been reported
Clinical trials have suggested that oral ingestion of the probiotic strains Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 results in vaginal colonization and prevention of adult UTI potentially by inhibiting uropathogen ascension from the vagina to the urinary tract
A total of 60 patients will be enrolled for this pilot study half of whom will be randomized to receive probiotics and the reminder of which will receive placebo 11 ratio 50 chance of being in each group A and B Treatment assignment will be double blinded and will last 6 months
UTI in girls occur when virulent bacteria migrate from the rectum and colonize the vagina and peri-urethral mucosa thus gaining access to the bladder In girls with spina bifida access to the bladder is greatly facilitated by catheter passage Antibiotic prophylaxis relies on maintaining a low dose of antibiotic in the urinary stream which decreases peri-urethral colonization and prevents proliferation of bacteria after they gain access to the bladder An alternative approach to daily antibiotic prophylaxis is to decrease the risk of urinary colonization with virulent bacteria by supplementing the normal bacteria flora with non-infection causing strains of bacteria
Probiotics are dietary supplements containing potentially beneficial bacterial strains such as Lactobacillus The safety of oral administration of probiotics has been demonstrated in several studies over the last 30 years Studies using Lactobacillus rhamnosus GG a probiotic introduced in the late 1980s to alleviate diarrhea have shown promising results when used for UTI prevention In one study researchers found that the subjects consuming GG drinks had fewer episodes of UTI compared to those women not receiving probiotics A placebo-controlled study in premature infants also used GG in an attempt to prevent UTI The number of urinary infections was reduced but statistically the difference was not significant Finally a recent randomized clinical trial demonstrated that the rate of UTI in children taking prophylactic antibiotics was similar to that of patients taking Lactobacillus acidophilus alone The efficacy of probiotic usage in the spina bifida population has not been reported
Clinical trials have suggested that oral ingestion of the probiotic strains Lactobacillus reuteri RC-14 and Lactobacillus rhamnosus GR-1 results in vaginal colonization and prevention of adult UTI potentially by inhibiting uropathogen ascension from the vagina to the urinary tract
A total of 60 patients will be enrolled for this pilot study half of whom will be randomized to receive probiotics and the reminder of which will receive placebo 11 ratio 50 chance of being in each group A and B Treatment assignment will be double blinded and will last 6 months
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