Trial Outcomes & Findings for Safety, Tolerability and Host Response to Lactobacillus Johnsonii (NCT NCT02349360)

NCT ID: NCT02349360

Last Updated: 2018-06-14

Results Overview

The number of participants reporting Adverse Events was reported.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 42 participants
• Primary outcome timeframe: 13 weeks
• Results posted on: 2018-06-14

Participant Flow

Participant milestones

Measure	Probiotic L. johnsonii N6.2 in capsule form administered for 8 weeks L. johnsonii N6.2: L. johnsonii N6.2 in capsule form administered for 8 weeks	Placebo Encapsulated starch placebo administered for 8 weeks Placebo: Encapsulated starch placebo administered for 8 weeks
Overall Study STARTED	21	21
Overall Study COMPLETED	21	20
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Probiotic L. johnsonii N6.2 in capsule form administered for 8 weeks L. johnsonii N6.2: L. johnsonii N6.2 in capsule form administered for 8 weeks	Placebo Encapsulated starch placebo administered for 8 weeks Placebo: Encapsulated starch placebo administered for 8 weeks
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Safety, Tolerability and Host Response to Lactobacillus Johnsonii

Baseline characteristics by cohort

Measure	Probiotic n=21 Participants L. johnsonii N6.2 10\^10 CFU in capsule form administered for 8 weeks L. johnsonii N6.2: L. johnsonii N6.2 10\^10 CFU in capsule form administered for 8 weeks	Placebo n=21 Participants Encapsulated starch placebo administered for 8 weeks Placebo: Encapsulated starch placebo administered for 8 weeks	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=93 Participants	21 Participants n=4 Participants	42 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	23 years n=93 Participants	21 years n=4 Participants	21 years n=27 Participants
Sex: Female, Male Female	16 Participants n=93 Participants	14 Participants n=4 Participants	30 Participants n=27 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	7 Participants n=4 Participants	12 Participants n=27 Participants
Region of Enrollment United States	21 Participants n=93 Participants	21 Participants n=4 Participants	42 Participants n=27 Participants

PRIMARY outcome

Timeframe: 13 weeks

Population: Subjects completing the probiotic and the placebo intervention.

The number of participants reporting Adverse Events was reported.

Outcome measures

Measure	Probiotic n=21 Participants L. johnsonii N6.2 10\^10 CFU in capsule form administered for 8 weeks L. johnsonii N6.2: L. johnsonii N6.2 10\^10 CFU in capsule form administered for 8 weeks (	Placebo n=20 Participants Encapsulated starch placebo administered for 8 weeks Placebo: Encapsulated starch placebo administered for 8 weeks
Number of Participants Reporting Adverse Events	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 13 weeks

Population: Subjects completing intervention and final blood draw after 4 week washout period.

Number of clinically relevant out of range values of the comprehensive metabolic panel and hemogram during intervention through washout period vs baseline.

Outcome measures

Measure	Probiotic n=21 Participants L. johnsonii N6.2 10\^10 CFU in capsule form administered for 8 weeks L. johnsonii N6.2: L. johnsonii N6.2 10\^10 CFU in capsule form administered for 8 weeks (	Placebo n=20 Participants Encapsulated starch placebo administered for 8 weeks Placebo: Encapsulated starch placebo administered for 8 weeks
Composite Measure of Blood Chemistry Profiles	0 events	0 events

Adverse Events

Probiotic

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Probiotic n=21 participants at risk L. johnsonii N6.2 10\^10 CFU in capsule form administered for 8 weeks L. johnsonii N6.2: L. johnsonii N6.2 10\^10 CFU in capsule form administered for 8 weeks	Placebo n=20 participants at risk Encapsulated starch placebo administered for 8 weeks Placebo: Encapsulated starch placebo administered for 8 weeks
Infections and infestations Sinus Infection	0.00% 0/21	5.0% 1/20 • Number of events 1
Injury, poisoning and procedural complications Fractured clavical	0.00% 0/21	5.0% 1/20 • Number of events 1
Infections and infestations Dental Abcess	4.8% 1/21 • Number of events 1	0.00% 0/20

Additional Information

Wendy Dahl Associate Professor

University of Florida

Phone: 3522943707

Email: wdahl@ufl.edu

Results disclosure agreements

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