Table 4 Long term clinical trials (≥4 months) using probiotics for BV treatment with antibiotics.

From: The right bug in the right place: opportunities for bacterial vaginosis treatment

Studies

Size

Type of study

Duration

Antibiotics treatment first

Time

Route of administration

Probiotics and cure rate

Probiotics (CFU)

Control (Placebo)

Control (Blank)

Statistics (Control vs. Probiotics)

Hummelen et al., 201059

42

R, DB, PC

6 months

Oral 400 mg metronidazole twice daily for 10 days

25 weeks

Oral capsule

L. rhamnosus GR-1 and L. reuteri RC-14 (42%)

2 × 109

Capsule (40%)

 

p = NS

Heczko et al., 201565

154

R, DB, PC

6 months

Oral metronidazole for 7 days

10 days

Oral capsules

L.gasseri 57C, L. fermentum 57A, and L. plantarum 57B (54.8%)

≥108

Capsule (53%)

 

p = 0.087

Russo et al., 201966

48

R, DB, PC

6 months

Oral 500 mg metronidazole twice a day for 1 week

10 days per month

Oral capsule

L. acidophilus GLA-14 and L. rhamnosus HN001 (70.83%)

5 × 109

Capsule (41.67 %)

 

p < 0.05

Larsson et al., 2008109

100

R, DB, PC

6 menstrual periods

Vaginal 2% clindamycin for 7 days

10 days for three menstrual cycles

Vaginal gelatine capsules

L. gasseri Lba EB01-DSM 14869 and L. rhamnosus Lbp PB01-DSM 14870 (65%)

108–109

Capsule (46%)

 

p = 0.042

Marcone et al., 2008107

84

R, AC

180 days

Oral Metronidazole 500 mg twice a day for 7 days

Once a week for 2 months

Vaginal tablet

L. rhamnosus (83%)

>4 × 104

 

Yes (67%)

p = NS

Marcone et al., 2010110

46

R, AC

12 months

Oral 500 mg metronidazole for 7 days

6 months

Vaginal capsule

L. rhamnosus GR-1 and L. reuteri RC-14 (not shown)

>4 × 104

 

Yes (not shown)

p = NS

Bradshaw et al., 2012111

268

R, DB, PC

6 months

Vaginal metronidazole for 7 days

12 days

Vaginal pessary

L. acidophilus KS400 (72%)

≥109

Pessary (73%)

 

p = NS

Recine et al., 2016112

250

R, AC

9 months

Oral 500 mg metronidazole twice a day for 1 week

7 months

Vaginal tablet

L. rhamnosus BMX 54 (79.7%)

≥104

 

Yes (20.3%)

p < 0.0001

Bohbot et al., 201851

78

R, DB, PC

196 days

Oral 500 mg metronidazole twice a day for 1 week

14 days

Vaginal capsule

L. crispatus IP 174178 (79.5%)

109

Capsule (59%)

 

p = 0.049

Cohen et al., 202062

228

R, DB, PC

24 weeks

Vaginal 0.75% metronidazole for 5 days

10 weeks

Vaginal applicators

L. crispatus CTV-05 (70%)

2 × 109

Inactive ingredient (55%)

 

p= 0.01

  1. Note: The studies are cited in chronological order, separated by oral and vaginal administrations.
  2. R randomized, DB double blind, PC placebo controlled, OB observer blind, AC active controlled, CFU colony-forming unit, NS not significant.