Trial Outcomes & Findings for Global Effects of a Probiotic Strain on Lactating Women (NCT NCT01124448)

Results Overview

Total milk bacterial count at the end of the study (after probiotic administration for 21 days), measured as log10 of the number of colony-forming units per mL of milk

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

one week

Results posted on

2014-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Lactobacillus Salivarius PS2 Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days) Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days	Lactobacillus Salivarius PS2B Lactating women without mastitis (n=15) Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days
Overall Study STARTED	25	15
Overall Study COMPLETED	23	12
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Lactobacillus Salivarius PS2 Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days) Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days	Lactobacillus Salivarius PS2B Lactating women without mastitis (n=15) Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days
Overall Study Lost to Follow-up	0	3
Overall Study Protocol Violation	2	0

Baseline Characteristics

Global Effects of a Probiotic Strain on Lactating Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lactobacillus Salivarius PS2 n=25 Participants Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days) Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days	Lactobacillus Salivarius PS2B n=15 Participants Lactating women without mastitis (n=15) Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days	Total n=40 Participants Total of all reporting groups
Age, Continuous	28.2 years STANDARD_DEVIATION 7.7 • n=5 Participants	29.0 years STANDARD_DEVIATION 7.8 • n=7 Participants	28.6 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	15 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Spain	25 participants n=5 Participants	15 participants n=7 Participants	40 participants n=5 Participants
Total milk bacterial count (initial)	4.08 log10 CFU/mL STANDARD_DEVIATION 0.20 • n=5 Participants	3.19 log10 CFU/mL STANDARD_DEVIATION 0.59 • n=7 Participants	3.63 log10 CFU/mL STANDARD_DEVIATION 0.39 • n=5 Participants

PRIMARY outcome

Timeframe: one week

Total milk bacterial count at the end of the study (after probiotic administration for 21 days), measured as log10 of the number of colony-forming units per mL of milk

Outcome measures

Outcome measures
Measure	Lactobacillus Salivarius PS2 n=23 Participants Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days) Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days	Lactobacillus Salivarius PS2B n=12 Participants Lactating women without mastitis (n=15) Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days
Evidence of Clinically Definite Mastitis Confirmed by Microbiological Cultures and Somatic Cell Counts	3.09 log10 CFU/mL Interval 2.9 to 3.28	2.90 log10 CFU/mL Interval 2.12 to 3.7

SECONDARY outcome

Timeframe: one year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: one year

Outcome measures

Outcome data not reported

Adverse Events

Lactobacillus Salivarius PS2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lactobacillus Salivarius PS2B

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. Juan M Rodríguez

Complutense University Madrid

Phone: 34 91 3943837

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place