Yeast-based Probiotic for Gut Health

TL
JW
Overseen ByJenny Whittington, MS

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the tolerability and efficacy of a yeast-based dietary supplement on gastrointestinal, mental, and skin health. Yeasts are naturally present on fruits and plants, and are used to bake bread, beer and wine. Some of these yeasts are commonly consumed and may actually benefit your gut health. The supplemental yeast could strengthen the gut lining or help good bacteria in the gut grow better.

In this study, the investigators will look at how two doses of a yeast-based supplement impacts gut health, bowel movement consistency, and mental health. The study will last 17 weeks and consist of 7 clinic visits (1 screening visit and 6 test visits).

Are You a Good Fit for This Trial?

This trial is for healthy adults interested in improving gut, mental, or skin health. Participants should not have major medical conditions and must be able to attend clinic visits over a 17-week period.

Inclusion Criteria

I am between 18 and 75 years old.
BMI less than 30 kg/m2
I have mild or moderate stomach or digestive discomfort.

Exclusion Criteria

Have allergies to study treatments or medical supplies such as latex, yeast, or cellulose
I have cancer, liver, kidney, digestive, heart, or metabolic diseases like diabetes.
Use excessive alcohol
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit
1 visit (in-person)

Treatment

Participants receive three treatments (placebo and two doses of Pichia kluyveri) for 4 weeks each, separated by 2-week washout periods

12 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Pichia kluyveri PK88

Trial Overview

The study tests two different doses of a yeast-based probiotic supplement (Pichia kluyveri PK88) compared to a placebo. It examines effects on gut health, bowel movements, mental well-being, and skin over 17 weeks.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Pichia kluyveri 9.9 x 10^7Experimental Treatment1 Intervention
Group II: Pichia kluyveri 1 x 10^8Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials
138
Recruited
38,200+

Biohm Technologies

Industry Sponsor

Trials
1
Recruited
140+