Phase I trial of a Lactobacillus crispatus vaginal suppository for prevention of recurrent urinary tract infection in women

Abstract

Objectives: We performed a phase I trial to assess the safety and tolerance of a Lactobacillus vaginal suppository for prevention of recurrent UTI.

Methods: Premenopausal women with a history of recurrent UTI were randomized to use L. crispatus CTV-05 or placebo vaginal suppositories daily for five days.

Results: 30 women were randomized (15 to L. crispatus CTV-05). No severe adverse events occurred. Mild to moderate vaginal discharge and genital irritation were reported by women in both study arms. Seven women randomized to L. crispatus CTV-05 developed pyuria without associated symptoms. Most women had high concentrations of vaginal H202-producing lactobacilli before randomization. L. crispatus, L. jensenii, and L. gasseri were the most common Lactobacillus species identified, with stable prevalence over time.

Conclusions: L. crispatus CTV-05 can be given as a vaginal suppository with minimal sideeffects to healthy women with a history of recurrent UTI. Mild inflammation of the urinary tract was noted in some women.

Figure 1

Randomization and followup of subjects.

Figure 2

Symptoms reported by $\ge$2 women at clinic visits ($P>.05$ for comparison of L. crispatus CTV-05 to placebo at all visits). CTV-05, L. crispatus CTV-05; DC, abnormal vaginal discharge; IRR, external genital or vaginal irritation; ODOR, vaginal odor; DYS, dysuria; HA, headache; APP, abdominal or pelvic pain/cramps; LBP, low back pain.

Figure 3

Representative rep-PCR DNA fingerprints from vaginal lactobacillus isolates. MW, Molecular weight standard; C, L. crispatus; J, L. jensenii, G, L. gasseri; *, L. crispatus CTV-05.

Figure 4

Prevalence of vaginal Lactobacillus species at clinic visits (N = 15 for each treatment group. $P>.05$ for comparison of L. crispatus CTV-05 to placebo at all visits except for L. gasseri at 1-week ($P=.02$)). CTV-05, L. crispatus CTV-05.