Trial Outcomes & Findings for Lactobacillus Probiotic for Prevention of UTI (NCT NCT03151967)
NCT ID: NCT03151967
Last Updated: 2023-03-01
Results Overview
Symptomatic UTI : Comparison of the number (%) of subjects over the 16-week study period following randomization, with at least one symptomatic UTI (as defined above) in the 2 intervention groups
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
27 participants
Primary outcome timeframe
Week 2-18
Results posted on
2023-03-01
Participant Flow
Participant milestones
| Measure |
Applicator With LACTIN-V Treatment
Vaginal applicator containing Lactobacillus crispatus CTV-05
Lactobacillus crispatus CTV-05: vaginal applicator with medium containing drug
|
Applicator With Placebo
Inactive vaginal applicator without any drug
Placebo: vaginal applicator with medium containing no drug
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lactobacillus Probiotic for Prevention of UTI
Baseline characteristics by cohort
| Measure |
Applicator With LACTIN-V Treatment
n=14 Participants
Vaginal applicator containing Lactobacillus crispatus CTV-05
Lactobacillus crispatus CTV-05: vaginal applicator with medium containing drug
|
Applicator With Placebo
n=13 Participants
Inactive vaginal applicator without any drug
Placebo: vaginal applicator with medium containing no drug
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 2-18Population: completed follow-up
Symptomatic UTI : Comparison of the number (%) of subjects over the 16-week study period following randomization, with at least one symptomatic UTI (as defined above) in the 2 intervention groups
Outcome measures
| Measure |
Applicator With LACTIN-V Treatment
n=12 Participants
Vaginal applicator containing Lactobacillus crispatus CTV-05
Lactobacillus crispatus CTV-05: vaginal applicator with medium containing drug
|
Applicator With Placebo
n=12 Participants
Inactive vaginal applicator without any drug
Placebo: vaginal applicator with medium containing no drug
|
|---|---|---|
|
UTI Incidence as Described Below, Over the 16 Week Study Period Following Randomization, in the LACTIN-V Treatment Group (Group A) as Compared to the Placebo Group (Group B).
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Weeks 0, 2, 6, 10, 14 and18Lactobacillus crispatus positive (as assessed by repPCR) at Weeks 0,2,6,10,14, and 18 in the Lactin-V group as compared to the placebo group
Outcome measures
| Measure |
Applicator With LACTIN-V Treatment
n=12 Participants
Vaginal applicator containing Lactobacillus crispatus CTV-05
Lactobacillus crispatus CTV-05: vaginal applicator with medium containing drug
|
Applicator With Placebo
n=12 Participants
Inactive vaginal applicator without any drug
Placebo: vaginal applicator with medium containing no drug
|
|---|---|---|
|
Parameter of Vaginal Colonization
Week 18
|
7 Number of Participants with Lactobac
|
0 Number of Participants with Lactobac
|
|
Parameter of Vaginal Colonization
Week 0
|
0 Number of Participants with Lactobac
|
0 Number of Participants with Lactobac
|
|
Parameter of Vaginal Colonization
Week 2
|
7 Number of Participants with Lactobac
|
0 Number of Participants with Lactobac
|
|
Parameter of Vaginal Colonization
Week 6
|
8 Number of Participants with Lactobac
|
0 Number of Participants with Lactobac
|
|
Parameter of Vaginal Colonization
Week 10
|
9 Number of Participants with Lactobac
|
0 Number of Participants with Lactobac
|
|
Parameter of Vaginal Colonization
Week 14
|
9 Number of Participants with Lactobac
|
0 Number of Participants with Lactobac
|
Adverse Events
Applicator With LACTIN-V Treatment
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Applicator With Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Applicator With LACTIN-V Treatment
n=14 participants at risk
Vaginal applicator containing Lactobacillus crispatus CTV-05
Lactobacillus crispatus CTV-05: vaginal applicator with medium containing drug
|
Applicator With Placebo
n=13 participants at risk
Inactive vaginal applicator without any drug
Placebo: vaginal applicator with medium containing no drug
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
7.1%
1/14 • 18 weeks
|
0.00%
0/13 • 18 weeks
|
|
Eye disorders
Eye disorders
|
0.00%
0/14 • 18 weeks
|
7.7%
1/13 • 18 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
28.6%
4/14 • 18 weeks
|
30.8%
4/13 • 18 weeks
|
|
Infections and infestations
Infections and Infestations
|
50.0%
7/14 • 18 weeks
|
46.2%
6/13 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
14.3%
2/14 • 18 weeks
|
0.00%
0/13 • 18 weeks
|
|
Nervous system disorders
Nervous system disorders
|
35.7%
5/14 • 18 weeks
|
15.4%
2/13 • 18 weeks
|
|
Renal and urinary disorders
Renal and urinary disorders
|
35.7%
5/14 • 18 weeks
|
53.8%
7/13 • 18 weeks
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
50.0%
7/14 • 18 weeks
|
53.8%
7/13 • 18 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
0.00%
0/14 • 18 weeks
|
15.4%
2/13 • 18 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place