Table 2.
Baseline characteristicsa of patients in the intent-to-treat (ITT; n = 578) and per-protocol (PP; n = 154) populations
| Characteristic | Placebo | Probiotic | p |
|---|---|---|---|
| Hormonal treatment ITT | 15 | 20 | 0.3388 |
| Hormonal treatment PP | 3 | 5 | 0.3798 |
| Contraception ITT | 89 | 91 | 0.6866 |
| Contraception PP | 26 | 20 | 0.5244 |
| Contraceptive tablets ITT | 66 | 71 | 0.4999 |
| Contraceptive tablets PP | 16 | 13 | 0.8095 |
| Transdermal contraception ITT | 10 | 6 | 0.3380 |
| Transdermal contraception PP | 2 | 0 | 0.2047 |
| Contraception condom ITT | 10 | 8 | 0.6750 |
| Contraception condom PP | 5 | 4 | 0.9480 |
| Contraception other ITT | 4 | 6 | 0.4951 |
| Contraception other PP | 3 | 3 | 0.9420 |
| Sexually active ITT | 270 | 266 | 0.5838 |
| Sexually active PP | 76 | 70 | 0.5646 |
| More than one sexual partner ITT | 1 | 1 | 0.9844 |
| More than one sexual partner PP | 0 | 0 | |
| Smoking ITT | 46 | 32 | 0.1120 |
| Smoking PP | 14 | 12 | 0.8888 |
| Vaginal douching ITT | 2 | 3 | 0.6310 |
| Vaginal douching PP | 1 | 1 | 0.9411 |
| Complaints at first visit (PP) | |||
| Vaginal itching | 7 | 6 | 0.9249 |
| Vaginal burning | 14 | 14 | 0.7301 |
| Vaginal pain | 1 | 1 | 0.9410 |
| Vaginal discharge | 79 | 70 | 0.5663 |
| Pelvic pain | 2 | 1 | 0.6221 |
| Conditions reported by investigators at first visit (PP) | |||
| Vaginal erythema | 0 | 3 | 0.0354 |
| Palpation tenderness | 1 | 1 | 0.9624 |
| Homogenous vaginal discharge | 78 | 71 | 0.9260 |
| Clue cell presence | 79 | 71 | 0.9160 |
| Positive amine test | 78 | 72 | 0.3632 |
| BV (Amsel’s criteria [13]) | 80 | 72 | 0.2559 |
| Vulvovaginal candidiasis | 0 | 1 | 0.2206 |
| Microbial species cultured from vaginal swabs collected at first visit b(PP) | |||
| Gardnerella vaginalis | 46 | 52 | 0.0628 |
| Streptococcus agalactiae | 17 | 15 | 0.9465 |
| Escherichia coli | 5 | 3 | 0.5646 |
| Enterococcus spp. | 0 | 1 | 0.2206 |
| Candida albicans | 2 | 0 | 0.1076 |
| Lactobacillus spp. | 48 | 44 | 0.8980 |
aAnalyses were not carried for age, sex, or race, as only Caucasian women aged 18–50 years were included
bOnly populations exceeding 105 organisms per swab were counted