Trial Outcomes & Findings for Survival of the Probiotic Lacticaseibacillus Paracasei Strain Shirota (LcS) in the GI Tract of Healthy Adults (NCT NCT05522777)

NCT ID: NCT05522777

Last Updated: 2024-12-06

Results Overview

The change in Live LcS numbers (CFU/g Feces) from baseline (Visit 2; Day 14) to the end of the ingestion period (Visit 4; Day 28) was measured by colony PCR method.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2024-12-06

Participant Flow

One participant withdrew at the baseline visit due to schedule conflict.

Participant milestones

Measure	Test Product Consumption Group Drink one bottle of Yakult a day: Yakult is a branded probiotic drink with 8x10\^9 CFU Lacticaseibacillus paracasei strain Shirota
Overall Study STARTED	26
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Test Product Consumption Group Drink one bottle of Yakult a day: Yakult is a branded probiotic drink with 8x10\^9 CFU Lacticaseibacillus paracasei strain Shirota
Overall Study Lack of Efficacy	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Survival of the Probiotic Lacticaseibacillus Paracasei Strain Shirota (LcS) in the GI Tract of Healthy Adults

Baseline characteristics by cohort

Measure	Test Product Consumption Group n=26 Participants Drink one bottle of Yakult a day Drink one bottle of Yakult a day: Yakult is a branded probiotic drink with 8x10\^9 CFU Lacticaseibacillus paracasei strain Shirota
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	32.0 years STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants
BMI	25.0 kg/m2 STANDARD_DEVIATION 2.7 • n=5 Participants

PRIMARY outcome

Timeframe: 14 days

The change in Live LcS numbers (CFU/g Feces) from baseline (Visit 2; Day 14) to the end of the ingestion period (Visit 4; Day 28) was measured by colony PCR method.

Outcome measures

Measure	Test Product Consumption Group n=24 Participants Drink one bottle of Yakult a day: Yakult is a branded probiotic drink with 8x10\^9 CFU Lacticaseibacillus paracasei strain Shirota
Change in Live LcS Numbers From Baseline (Day 14) to the End of the Ingestion Period (Day 28). Number of LcS at Day 14	2.14 Log 10 CFU/g Feces Interval 1.89 to 2.44
Change in Live LcS Numbers From Baseline (Day 14) to the End of the Ingestion Period (Day 28). Number of LcS at Day 28	5.27 Log 10 CFU/g Feces Interval 4.5 to 6.04

SECONDARY outcome

Timeframe: 7 days

The change in Live LcS numbers (CFU/g Feces) from baseline (Visit 2; Day 14) to the mid of ingestion period (Visit 3 ; Day 21) was measured by colony PCR method.

Outcome measures

Measure	Test Product Consumption Group n=24 Participants Drink one bottle of Yakult a day: Yakult is a branded probiotic drink with 8x10\^9 CFU Lacticaseibacillus paracasei strain Shirota
Change in LcS Number From Baseline (Day 14) to the Mid of Ingestion Period (Day 21). Number of LcS at Day 14	2.17 Log10 CFU/g feces Interval 1.89 to 2.44
Change in LcS Number From Baseline (Day 14) to the Mid of Ingestion Period (Day 21). Number of LcS at Day 21	6.37 Log10 CFU/g feces Interval 5.88 to 6.86

SECONDARY outcome

Timeframe: 14 days

The change in LcS numbers from the end of the ingestion period (Visit 4; Day 28) to the end of follow-up period (Visit 5; Day 42) was measured by colony PCR method..

Outcome measures

Measure	Test Product Consumption Group n=24 Participants Drink one bottle of Yakult a day: Yakult is a branded probiotic drink with 8x10\^9 CFU Lacticaseibacillus paracasei strain Shirota
Change in LcS Numbers From the End of the Ingestion Period (Day 28) and to the End of Follow-up (Day 42). Number of LcS at Day 28	5.27 Log 10 CFU/g feces Interval 4.5 to 6.04
Change in LcS Numbers From the End of the Ingestion Period (Day 28) and to the End of Follow-up (Day 42). Number of LcS at Day 42	2.14 Log 10 CFU/g feces Interval 1.93 to 2.35

Adverse Events

Test Product Consumption Group

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

Hideyuki Shibata

Yakult U.S.A. Inc

Phone: 714-434-6500

Email: hideyuki.shibata@yakultusa.com

Results disclosure agreements

• Principal investigator is a sponsor employee Not to disclose the data relating to or the results of the Study to any third party, except as otherwise agreed to in writing by Sponsor for a period of three (3) years from the date the last clinic visit is completed by a Research Subject.
• Publication restrictions are in place

Restriction type: OTHER