Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06149676
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-11-21
Brief Title:
A Novel Probiotic-antibiotic Combination to Prevent Recurrent Urinary Tract Infections
Sponsor:
Ann Robert H Lurie Childrens Hospital of Chicago
Organization:
Ann Robert H Lurie Childrens Hospital of Chicago
Study Overview
Official Title:
A Novel Probiotic-antibiotic Combination to Prevent Recurrent Urinary Tract Infections
Status:
RECRUITING
Status Verified Date:
2023-11
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:
Patients with recurrent UTI were randomized to receive either the probiotic Sacchromyces Boulardii at enrollment and the intracellularly active Ciprofloxacin with their first UTI episode after enrollment or they received standard of care treatment
Detailed Description:
At the time of consent participants will be given 20 mgkg of the antibiotic ciprofloxacin If the participant has symptoms of a UTI or have a positive urine culture at enrollment they will take the antibiotic every 12 hours for 14 days If the participant does not have symptoms of a UTI at enrollment the antibiotic will be taken only if needed at home upon the first occurrence of a UTI
At the time of consent participants will also be given 250 mg of the probiotic S
boulardii taken once daily for 6 months irrespective of symptoms
- Throughout the study participants will receive their standard clinical care for recurrent UTI treatment which includes bowel and bladder dysfunction management and other prescribed non-antibiotic interventions at the managing providers clinical discretion
At the time of consent participants will also be given 250 mg of the probiotic S
boulardii taken once daily for 6 months irrespective of symptoms
- Throughout the study participants will receive their standard clinical care for recurrent UTI treatment which includes bowel and bladder dysfunction management and other prescribed non-antibiotic interventions at the managing providers clinical discretion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None