Trial Outcomes & Findings for Intravaginal LACTIN-V for Prevention of Recurrent Urinary Tract Infection (NCT NCT00305227)

NCT ID: NCT00305227

Last Updated: 2023-04-14

Results Overview

Recurrent urinary tract infection after initiation of intervention. Culture-confirmed to contain uropathogen.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

100 participants

Primary outcome timeframe

10 weeks

Results posted on

2023-04-14

Participant Flow

February 2006 \~ February 2009 University of Washington student health center

Participant milestones

Participant milestones
Measure	Lactin-V Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.	Placebo Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
Overall Study STARTED	50	50
Overall Study COMPLETED	43	44
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Lactin-V Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.	Placebo Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
Overall Study Lost to Follow-up	7	6

Baseline Characteristics

Intravaginal LACTIN-V for Prevention of Recurrent Urinary Tract Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lactin-V n=50 Participants Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.	Placebo n=50 Participants Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.	Total n=100 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	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	21 years FULL_RANGE 18-31 • n=5 Participants	21 years FULL_RANGE 18-36 • n=7 Participants	21 years FULL_RANGE 18-36 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks

Population: The reported analysis was by intention to treat. All study participants were used, except for 4 participants in whom the major outcome measure was unevaluable.

Recurrent urinary tract infection after initiation of intervention. Culture-confirmed to contain uropathogen.

Outcome measures

Outcome measures
Measure	Lactin-V n=48 Participants Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.	Placebo n=48 Participants Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
Incidence of Urinary Tract Infection	7 participants	13 participants

SECONDARY outcome

Timeframe: 4 months

Outcome measures

Outcome measures
Measure	Lactin-V n=50 Participants Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.	Placebo n=50 Participants Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
Incidence of Vaginal Discharge	4 Participants	5 Participants

Adverse Events

Lactin-V

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Ann Stapleton, MD

University of Washington

Phone: 206-616-4121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Lactin-V n=50 participants at risk Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.	Placebo n=50 participants at risk Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
Renal and urinary disorders Painful urination	2.0% 1/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.	4.0% 2/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.
Renal and urinary disorders Urinary frequency	0.00% 0/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.	2.0% 1/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.
General disorders Pain in lower abdomen	0.00% 0/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.	2.0% 1/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.
General disorders Low back pain	0.00% 0/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.	2.0% 1/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.
Renal and urinary disorders Other urinary symptoms	4.0% 2/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.	0.00% 0/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.
Reproductive system and breast disorders Vaginal odor	6.0% 3/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.	8.0% 4/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.
Reproductive system and breast disorders Abnormal vaginal discharge	8.0% 4/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.	10.0% 5/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.
Reproductive system and breast disorders Vaginal itch	10.0% 5/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.	6.0% 3/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.
General disorders Painful intercourse	2.0% 1/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.	0.00% 0/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.
General disorders Redness/irritation of genitals	4.0% 2/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.	0.00% 0/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.
General disorders Genital swelling	4.0% 2/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.	0.00% 0/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.
Reproductive system and breast disorders Other vaginal symptoms	40.0% 20/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.	34.0% 17/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.
General disorders Diarrhea	2.0% 1/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.	2.0% 1/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.
General disorders Abdominal discomfort	2.0% 1/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.	2.0% 1/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.
General disorders Other symptoms	2.0% 1/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.	0.00% 0/50 • 10 weeks for serious adverse events Other adverse events (minor side effects) information was collected after the first week of intense(5 doses) dosing. The results presented were not specifically elicited by type of effect, i.e. they were not prompted for the nature of their side effect.