Ignite Creation Date:
2024-05-05 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 9:57 AM
Study NCT ID:
NCT00781625
Status:
UNKNOWN
Last Update Posted:
2008-10-31
First Post:
2008-10-28
Brief Title:
Probiotics as a Prophylactic Aid in Women With Recurrent Urinary Tract Infections UTIs
Sponsor:
University Hospital Akershus
Organization:
University Hospital Akershus
Study Overview
Official Title:
ProbioticsLactobacillus as a Prophylactic Aid in Recurrent Bacterial Cystitis in Women A Randomized Prospective Double-Blinded Placebo Controlled Multi-Center Study
Status:
UNKNOWN
Status Verified Date:
2008-10
Last Known Status:
RECRUITING
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:
To investigate if administration of probiotics either orally or vaginally
Can reduce the number of episodes of acute bacterial cystitis andor
Has tolerable adverse effect profile
Improves general QoL in these women
Improves the immune function and other physiological stress markers
Reduces inflammation in urinary bladder epithelium
Can reduce the number of episodes of acute bacterial cystitis andor
Has tolerable adverse effect profile
Improves general QoL in these women
Improves the immune function and other physiological stress markers
Reduces inflammation in urinary bladder epithelium
Detailed Description:
Chronic recurrent bacterial cystitis is a condition that is disabling to a great extent and which influences quality of life and freedom of movement The episodes can be painful and lead to extensive use of antibiotics which in itself promotes development of bacterial strains increasingly resistant to antibiotics but do not prevent relapses Almost all cystitis in women are ascending infections from bacteria in the vagina following colonization from the rectum There have however been reported indications that there may be bacteria colonies within the urothelium that might give rise to relapses of the infections rather than pure reinfection from ascending pathogens
Probiotics are cultures of viable microorganisms which show a positive effect on the general condition of the host when administered Among the lactic acid bacteria LAB lactobacilli are the most commonly used for probiotics and they have an excellent safety record In terms of UTI weekly or twice weekly intravaginal instillation of Lactobacillus strains GR-1 and B-54 have led to reduced recurrences This concept has been supported by a 2006 pilot study showing that intravaginal administration of Lactobacillus crispatus GAI 98322 every two days for one year had the potential to reduce the UTI recurrences Another approach has been taken whereby lactobacilli are administered orally with a view of simulating how the pathogens reach the vagina The studies have shown that L rhamnosus GR-1 and L reuteri formerly fermentum RC-14 can reach the vagina after daily oral ingestion and they can lower the bacterial and yeast pathogen numbers
The aim of the study is to try to normalize the vaginal bacteriological milieu so that the more pathogenic subpopulation of bacteria strains are displaced and are less likely to cause UTI
Probiotics are cultures of viable microorganisms which show a positive effect on the general condition of the host when administered Among the lactic acid bacteria LAB lactobacilli are the most commonly used for probiotics and they have an excellent safety record In terms of UTI weekly or twice weekly intravaginal instillation of Lactobacillus strains GR-1 and B-54 have led to reduced recurrences This concept has been supported by a 2006 pilot study showing that intravaginal administration of Lactobacillus crispatus GAI 98322 every two days for one year had the potential to reduce the UTI recurrences Another approach has been taken whereby lactobacilli are administered orally with a view of simulating how the pathogens reach the vagina The studies have shown that L rhamnosus GR-1 and L reuteri formerly fermentum RC-14 can reach the vagina after daily oral ingestion and they can lower the bacterial and yeast pathogen numbers
The aim of the study is to try to normalize the vaginal bacteriological milieu so that the more pathogenic subpopulation of bacteria strains are displaced and are less likely to cause UTI
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 |
|---|---|---|---|
| 087922Shdir | None | None | None |