Drink one bottle of Yakult a day for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Yakult U.S.A. Inc, Fountain Valley, CA
Healthy Subjects (HS)+1 More
Drink one bottle of Yakult a day - Other
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

The objective of this study is to investigate the survival of Lacticaseibacillus paracasei strain Shirota (LcS) in the human gastrointestinal (GI) tract after consumption of probiotics fermented milk product containing 8x10^9 LcS. This study is a single-arm, open-label study with a 14-d run-in (baseline), 14-d consumption period, and 14-d follow-up. Participants will maintain habitual dietary and lifestyle practices with the exception of avoiding fermented foods and beverages throughout the 42-d trial. The number of live LcS in fecal samples will be assessed after 14 d consumption of a fermented milk product.

Eligible Conditions

  • Healthy Subjects (HS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

0 Primary · 1 Secondary · Reporting Duration: 14 days

14 days
Live LcS counts (CFU/g feces)

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Trial Design

1 Treatment Group

Test product consumption group
1 of 1
Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Drink one bottle of Yakult a day · No Placebo Group · N/A

Test product consumption group
Other
Experimental Group · 1 Intervention: Drink one bottle of Yakult a day · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 14 days
Closest Location: Yakult U.S.A. Inc · Fountain Valley, CA
Photo of california 1Photo of california 2Photo of california 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Healthy Subjects (HS)
0 CompletedClinical Trials

Who is running the clinical trial?

Illinois Institute of TechnologyOTHER
19 Previous Clinical Trials
6,719 Total Patients Enrolled
Biofortis Clinical Research, Inc.Industry Sponsor
10 Previous Clinical Trials
993 Total Patients Enrolled
4 Trials studying Healthy Subjects (HS)
288 Patients Enrolled for Healthy Subjects (HS)
Yakult U.S.A. Inc.Lead Sponsor
Dawn Beckman, MDPrincipal InvestigatorBiofortis Clinical Research, Inc.
5 Previous Clinical Trials
320 Total Patients Enrolled
1 Trials studying Healthy Subjects (HS)
60 Patients Enrolled for Healthy Subjects (HS)

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You eat breakfast regularly.\n
You are willing to consume the study product per the protocol instructions.
You are willing to maintain your usual diet and lifestyle throughout the trial and to refrain from exclusionary medications, supplements, and products.
You are a current user of tobacco products or a former user of any tobacco product (not used within 6 months) and have no plan to change nicotine habits during the study period.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.