Trial Outcomes & Findings for The Efficacy of Probiotics to Reduce Antepartum Group B Streptococcus Colonization. (NCT NCT03696953)

NCT ID: NCT03696953

Last Updated: 2024-03-21

Results Overview

Qualitative GBS culture results

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 109 participants
• Primary outcome timeframe: 36 weeks gestation
• Results posted on: 2024-03-21

Participant Flow

Participant milestones

Measure	Probiotic Florajen3 Combination Probiotic Product 15 billion CFU per capsule 1 capsule daily from 28 weeks until the time of birth. Florajen3: Probiotic combination product One capsule daily by mouth.	Placebo Microcrystalline Cellulose
Overall Study STARTED	55	54
Overall Study COMPLETED	39	44
Overall Study NOT COMPLETED	16	10

Reasons for withdrawal

Measure	Probiotic Florajen3 Combination Probiotic Product 15 billion CFU per capsule 1 capsule daily from 28 weeks until the time of birth. Florajen3: Probiotic combination product One capsule daily by mouth.	Placebo Microcrystalline Cellulose
Overall Study Withdrawal by Subject	6	1
Overall Study missed GBS swabs	2	2
Overall Study lost study bottle containing capsules	2	0
Overall Study Premature birth	1	4
Overall Study Gestational hypertension	1	1
Overall Study Gestational diabetes	2	1
Overall Study Fetal demise-Genetic abnormality	1	0
Overall Study Changed prenatal provider	1	1

Baseline Characteristics

The Efficacy of Probiotics to Reduce Antepartum Group B Streptococcus Colonization.

Baseline characteristics by cohort

Measure	Probiotic n=39 Participants Florajen3 Combination Probiotic Product 15 billion CFU per capsule 1 capsule daily from 28 weeks until the time of birth. Florajen3: Probiotic combination product One capsule daily by mouth.	Placebo n=44 Participants Microcrystalline Cellulose	Total n=83 Participants Total of all reporting groups
Age, Continuous	28.6 years STANDARD_DEVIATION 5.4 • n=5 Participants	28.4 years STANDARD_DEVIATION 5.5 • n=7 Participants	28.5 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	44 Participants n=7 Participants	83 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	23 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Parity Nulliparous	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants
Parity Multiparous	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Parity Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 36 weeks gestation

Population: Number of GBS Culture Positive Participants at 36 week standard of care cultures

Qualitative GBS culture results

Outcome measures

Measure	Probiotic n=39 Participants Florajen3 Combination Probiotic Product 15 billion CFU per capsule 1 capsule daily from 28 weeks until the time of birth. Florajen3: Probiotic combination product One capsule daily by mouth.	Placebo n=44 Participants Microcrystalline Cellulose
Qualitative GBS Culture Result Positive GBS culture	6 Participants	9 Participants
Qualitative GBS Culture Result Negative GBS culture	33 Participants	35 Participants

SECONDARY outcome

Timeframe: 36 weeks gestation

Population: Mean GBS Colony Forming Units (CFU)

Amount of GBS on each vaginal and rectal swab. Each swab was vortexed in 1 mL of PBS and plated onto Granada agar. Quantitative GBS colonization measured as the number of GBS colonies on Granada agar plate multiplied by the inverse of the dilution factor. The results were reported in CFU. No GBS present indicates negative. Positive results are reports numerically.

Outcome measures

Measure	Probiotic n=39 Participants Florajen3 Combination Probiotic Product 15 billion CFU per capsule 1 capsule daily from 28 weeks until the time of birth. Florajen3: Probiotic combination product One capsule daily by mouth.	Placebo n=44 Participants Microcrystalline Cellulose
GBS Quantitative Colony Counts in Colony Forming Units (CFU) Vaginal	11.32 CFU Standard Deviation 6.65	317.1 CFU Standard Deviation 1957.1
GBS Quantitative Colony Counts in Colony Forming Units (CFU) Rectal	604.2 CFU Standard Deviation 2684.2	2046.6 CFU Standard Deviation 12805.4

SECONDARY outcome

Timeframe: 36 weeks gestation

Population: The Antepartum Gastrointestinal Symptom Assessment is a composite of 10 GI symptoms (Nausea, Vomiting, Diarrhea, Sour Taste, Bad Breath, Burping/Belching, Bloating, Heartburn, Diarrhea, Constipation) each scored from 1 (no problem) to 5 (very severe problem), leading to a composite score Minimum of 10 and maximum of 50. Lower scores indicate fewer and/or less severe GI symptoms. Higher scores indicate more frequent and/or more severe GI symptoms.

Antepartum Gastrointestinal Symptom Assessment Scores

The Antepartum Gastrointestinal Symptom Assessment is a composite of 10 GI symptoms (Nausea, Vomiting, Diarrhea, Sour Taste, Bad Breath, Burping/Belching, Bloating, Heartburn, Diarrhea, Constipation) each scored from 1 (no problem) to 5 (very severe problem), leading to a composite score between 10-50. Lower scores indicate fewer and/or less severe GI symptoms. Higher scores indicate more frequent and/or more severe GI symptoms.

Outcome measures

Measure	Probiotic n=39 Participants Florajen3 Combination Probiotic Product 15 billion CFU per capsule 1 capsule daily from 28 weeks until the time of birth. Florajen3: Probiotic combination product One capsule daily by mouth.	Placebo n=44 Participants Microcrystalline Cellulose
Antepartum Gastrointestinal Symptom Assessment 36 week AP-GI-SA Score	13.58 score on a scale Standard Deviation 2.77	15.64 score on a scale Standard Deviation 3.96
Antepartum Gastrointestinal Symptom Assessment Baseline (28 week) AP-GI-SA Score	14.7 score on a scale Standard Deviation 3.2	16.2 score on a scale Standard Deviation 4.8

OTHER_PRE_SPECIFIED outcome

Timeframe: At the time of admission to the hospital for labor and birth (intrapartum) (Time frame will vary by participant and their health status, at or beyond 36 weeks 0/7 days gestation until 42 weeks 0/7 days gestation)

Population: Qualitative GBS culture positive or negative. No GBS on the plate indicates a negative culture. Any GBS on the plate indicates a positive culture.

Number of women with positive GBS vaginal to rectal colonization at the time of admission to the hospital for labor and birth. This measure was only collected on participants in the substudy.

Outcome measures

Measure	Probiotic n=14 Participants Florajen3 Combination Probiotic Product 15 billion CFU per capsule 1 capsule daily from 28 weeks until the time of birth. Florajen3: Probiotic combination product One capsule daily by mouth.	Placebo n=16 Participants Microcrystalline Cellulose
Intrapartum GBS Culture Result GBS culture changed to Positive (36 weeks to negative Intrapartum	1 Participants	2 Participants
Intrapartum GBS Culture Result Intrapartum Culture Positive	3 Participants	3 Participants
Intrapartum GBS Culture Result Intrapartum Culture Negative	11 Participants	12 Participants
Intrapartum GBS Culture Result GBS culture changed to Negative (36 weeks to positive Intrapartum	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-2 hours of life

Population: Neonatal oral/nasopharynx swabs. No GBS on plate indicates a negative culture. Any GBS present indicates a positive.

Number of Neonates with Positive GBS ) oral/nasopharynx colonization within 1-2 hours of life

Outcome measures

Measure	Probiotic n=14 Participants Florajen3 Combination Probiotic Product 15 billion CFU per capsule 1 capsule daily from 28 weeks until the time of birth. Florajen3: Probiotic combination product One capsule daily by mouth.	Placebo n=16 Participants Microcrystalline Cellulose
Neonatal GBS Oral/Nasopharynx Colonization	0 Participants	0 Participants

Adverse Events

Probiotic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Lisa Hanson

Marquette University, College of Nursing

Phone: 1-414-288-3841

Email: lisa.hanson@marquette.edu

Results disclosure agreements

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