Trial Outcomes & Findings for Probiotics as Adjuvant Treatment for Bacterial Vaginosis (NCT NCT03894813)

Last Updated: 2021-07-09

Results Overview

Clinical signs and symptoms of bacteria vaginosis (BV), including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at baseline, the number of participants with related clinical signs or symptoms at Baseline were calculated.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

126 participants

Primary outcome timeframe

1 day before starting treatment

Results posted on

2021-07-09

Participant Flow

Women who came to the gynaecological clinic of Peking University Shenzhen Hospital, China, between March 2019 and June 2019 with abnormal vaginal discharge symptoms were recruited.

Participant milestones

Participant milestones
Measure	Probiotics and Metronidazole Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days) "Probiotics" and "Metronidazole": Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)	Metronidazole Vaginal Metronidazole vaginal suppositories(1 suppositories,qd,7 days ) Metronidazole Vaginal: Metronidazole Suppositories,qd, 7 days
Overall Study STARTED	63	63
Overall Study COMPLETED	52	47
Overall Study NOT COMPLETED	11	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Probiotics and Metronidazole Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days) "Probiotics" and "Metronidazole": Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)	Metronidazole Vaginal Metronidazole vaginal suppositories(1 suppositories,qd,7 days ) Metronidazole Vaginal: Metronidazole Suppositories,qd, 7 days
Overall Study Adverse Event	1	1
Overall Study Lack of Efficacy	3	3
Overall Study Lost to Follow-up	1	0
Overall Study Pregnancy	2	1
Overall Study Protocol Violation	3	7
Overall Study Withdrawal by Subject	1	3
Overall Study Complain of the research staff and refused to continue the trial	0	1

Baseline Characteristics

Probiotics as Adjuvant Treatment for Bacterial Vaginosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Probiotics and Metronidazole n=52 Participants Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days) "Probiotics" and "Metronidazole": Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)	Metronidazole Vaginal n=47 Participants Metronidazole vaginal suppositories(1 suppositories,qd,7 days ) Metronidazole Vaginal: Metronidazole Suppositories,qd, 7 days	Total n=99 Participants Total of all reporting groups
Age, Continuous	34.2 years STANDARD_DEVIATION 7.0 • n=5 Participants	33.3 years STANDARD_DEVIATION 7.5 • n=7 Participants	33.8 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	47 Participants n=7 Participants	99 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	52 Participants n=5 Participants	47 Participants n=7 Participants	99 Participants n=5 Participants
Employment status Stable job	43 Participants n=5 Participants	41 Participants n=7 Participants	84 Participants n=5 Participants
Employment status Unemployed or unstable work	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Smoking	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Current relationship status Married	36 Participants n=5 Participants	26 Participants n=7 Participants	62 Participants n=5 Participants
Current relationship status Single, divorced or separated	16 Participants n=5 Participants	21 Participants n=7 Participants	37 Participants n=5 Participants
Childbirth history At least one previous birth	31 Participants n=5 Participants	26 Participants n=7 Participants	57 Participants n=5 Participants
Childbirth history No birth before	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Sexual activity Sexual activity (vaginal sex) ≥ 3 times per one month	28 Participants n=5 Participants	20 Participants n=7 Participants	48 Participants n=5 Participants
Sexual activity Had no sexual activity in the last half of the year or vaginal sex less than 3 times per one month	24 Participants n=5 Participants	27 Participants n=7 Participants	51 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day before starting treatment

Population: Full analysis set of all randomized participants, that is 126, who had baseline samples were tested.

Outcome measures

Outcome measures
Measure	Probiotics and Metronidazole n=63 Participants Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days) "Probiotics" and "Metronidazole": Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)	Metronidazole Vaginal n=63 Participants Metronidazole vaginal suppositories(1 suppositories,qd,7 days ) Metronidazole Vaginal: Metronidazole Suppositories,qd, 7 days
Number of Participants With Related Clinical Signs or Symptoms at Baseline	63 Participants	63 Participants

PRIMARY outcome

Timeframe: the 30th day after starting treatment

Clinical signs and symptoms of BV, including homogeneous and thin vaginal discharge, unpleasant odour (such as a "fishy" smell) and vulvar discomfort (such as itching or burning), were recorded at the 30-day, the number of participants with clinically effective (with the sign or symptoms disappeared or released compared with the baseline data) were calculated.

Outcome measures

Outcome measures
Measure	Probiotics and Metronidazole n=52 Participants Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days) "Probiotics" and "Metronidazole": Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)	Metronidazole Vaginal n=47 Participants Metronidazole vaginal suppositories(1 suppositories,qd,7 days ) Metronidazole Vaginal: Metronidazole Suppositories,qd, 7 days
Number of Participants With Clinically Effective in Each Study Arm in the 30-day Follow-up	30 Participants	28 Participants

PRIMARY outcome

Timeframe: the 90th day after starting treatment

Outcome measures

Outcome measures
Measure	Probiotics and Metronidazole n=30 Participants Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days) "Probiotics" and "Metronidazole": Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)	Metronidazole Vaginal n=28 Participants Metronidazole vaginal suppositories(1 suppositories,qd,7 days ) Metronidazole Vaginal: Metronidazole Suppositories,qd, 7 days
Number of Participants With Clinically Effective in Each Study Arm at the 90-day Follow-up	19 Participants	23 Participants

PRIMARY outcome

Timeframe: the 30th day after starting treatment

A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-6. Participants who were clinical failures, or had a Nugent score ≥ 7 were therapeutic failures.

Outcome measures

Outcome measures
Measure	Probiotics and Metronidazole n=52 Participants Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days) "Probiotics" and "Metronidazole": Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)	Metronidazole Vaginal n=52 Participants Metronidazole vaginal suppositories(1 suppositories,qd,7 days ) Metronidazole Vaginal: Metronidazole Suppositories,qd, 7 days
Number of Participants With Bacteriological Cure in Each Study Arm at the 30-day Follow-up	30 Participants	28 Participants

PRIMARY outcome

Timeframe: the 90th day after starting treatment

Outcome measures

Outcome measures
Measure	Probiotics and Metronidazole n=30 Participants Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days) "Probiotics" and "Metronidazole": Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)	Metronidazole Vaginal n=28 Participants Metronidazole vaginal suppositories(1 suppositories,qd,7 days ) Metronidazole Vaginal: Metronidazole Suppositories,qd, 7 days
Number of Participants With Bacteriological Cure in Each Study Arm at the 90-day Follow-up	19 Participants	23 Participants

Adverse Events

Probiotics and Metronidazole

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Metronidazole Vaginal

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Probiotics and Metronidazole n=63 participants at risk Probiotics: Oral probiotics(Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) ) (qd, 30 days); Metronidazole: Metronidazole vaginal suppositories (qd,7 days) "Probiotics" and "Metronidazole": Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)	Metronidazole Vaginal n=63 participants at risk Metronidazole vaginal suppositories(1 suppositories,qd,7 days ) Metronidazole Vaginal: Metronidazole Suppositories,qd, 7 days
Infections and infestations vaginal itching or burning	7.9% 5/63 • 6 months All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none were observed.	9.5% 6/63 • 6 months All-Cause Mortality and Serious Adverse Events were monitored/assessed, but none were observed.

Additional Information

Prof. Shangrong Fan

Peking University Shenzhen Hospital

Phone: 86-0755-83923333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place