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Trial Outcomes & Findings for Oral Probiotics Reduce Group B Streptococci Colonization in Pregnant Women (NCT NCT01577108)

NCT ID: NCT01577108

Last Updated: 2017-03-31

Results Overview

To exam the GBS colonization in both vagina and rectum when childbirth. The purpose of this study is to examine whether oral taking Lactobacillus-containing probiotics can reduce the GBS colonization rate of vagina and rectum in pregnant women who present with GBS-positive.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

110 participants

Primary outcome timeframe

2 weeks after taking probiotic

Results posted on

2017-03-31

Participant Flow

Participant milestones

Participant milestones
Measure
Probiotics, GBS Test
Treated with 2 oral probiotics once daily before sleeping for 14 days GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days
Non-probiotics, GBS Test
Treated with 2 placebo capsules once daily before sleeping for 14 days GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days
Overall Study
STARTED
54
56
Overall Study
COMPLETED
49
50
Overall Study
NOT COMPLETED
5
6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Probiotics Reduce Group B Streptococci Colonization in Pregnant Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Probiotics, GBS Test
n=49 Participants
Treated with 2 oral probiotics once daily before sleeping for 14 days GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days
Non-probiotics, GBS Test
n=50 Participants
Treated with 2 placebo capsules once daily before sleeping for 14 days GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days
Total
n=99 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
49 Participants
n=99 Participants
50 Participants
n=107 Participants
99 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Female
49 Participants
n=99 Participants
50 Participants
n=107 Participants
99 Participants
n=206 Participants
Sex: Female, Male
Male
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Pregnancy, 35-37 weeks
49 Participants
n=99 Participants
50 Participants
n=107 Participants
99 Participants
n=206 Participants

PRIMARY outcome

Timeframe: 2 weeks after taking probiotic

Population: The GBS colonization results changed from positive to negative in 21 women in the probiotic group (42.9%) and in nine women in the placebo group (18.0%) during this period.

To exam the GBS colonization in both vagina and rectum when childbirth. The purpose of this study is to examine whether oral taking Lactobacillus-containing probiotics can reduce the GBS colonization rate of vagina and rectum in pregnant women who present with GBS-positive.

Outcome measures

Outcome measures
Measure
Probiotics, GBS Test
n=49 Participants
Treated with 2 oral probiotics once daily before sleeping for 14 days GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days Number of GBS-Positive pregnant women who became GBS-Negative at childbirth is 21 in the probiotic group (42.9%).
Non-probiotics, GBS Test
n=50 Participants
Treated with 2 placebo capsules once daily before sleeping for 14 days GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days Number of GBS-Positive pregnant women who became GBS-Negative at childbirth is 9 in the probiotic group (18.0%).
Number of GBS-Positive Pregnant Women Who Became GBS-Negative at Childbirth
21 Participants
9 Participants

Adverse Events

Probiotics, GBS Test

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Non-probiotics, GBS Test

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ming Ho, MD

China Medical University Hospital

Phone: 886422052121

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place