NCT07867496

Brief Summary

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 your gut lining or help good bacteria in your gut grow better. In this study, we will look at how two doses of a yeast-baaed supplement impacts your gut health, your bowel movement consistency, your and mental health. the study will last 17 weeks and consist of 7 clinic visits (1 screening visit and 6 test visits).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Nov 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

12 months

First QC Date

October 5, 2026

Last Update Submit

October 5, 2026

Conditions

Healthy Adult ParticipantsGut Health

Keywords

ProbioticGut healthDietary SupplementYeast-based Probiotic

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal Symptom Rating Scale (GSRS)

    The Gastrointestinal Symptom Rating Scale (GSRS) is a widely used tool for measuring gastrointestinal symptoms across five domains. The GSRS is scored between "No discomfort" and "Very severe discomfort"

    4 weeks

Secondary Outcomes (1)

  • Tumor Necrosis Factor Alpha

    4 weeks

Study Arms (3)

Pichia kluyveri 9.9 x 10^7

EXPERIMENTAL
Dietary Supplement: 9.9 x 10^7 Pichia kluyveri PK88

Pichia kluyveri 1 x 10^8

EXPERIMENTAL
Dietary Supplement: 1 x 10^8 Pichia kluyveri PK88

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

9.9 x 10^7 Pichia kluyveri PK88DIETARY_SUPPLEMENT

9.9 x 10\^7 Pichia kluyveri in microcrystalline cellulose and hypromellose

Pichia kluyveri 9.9 x 10^7
1 x 10^8 Pichia kluyveri PK88DIETARY_SUPPLEMENT

1 x 10\^8 Pichia kluyveri in microcrystalline cellulose and hypromellose

Pichia kluyveri 1 x 10^8
PlaceboDIETARY_SUPPLEMENT

Placebo - cellulose and hypromellose

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • between 18-75 years old
  • BMI \<30 kg/m2
  • mild/moderate gastrointestinal distress

You may not qualify if:

  • Have taken antibiotics within two months of enrollment in the study
  • Are currently taking statins, metformin, NSAIDs, and MAO inhibitors or other medications that could interfere with study outcomes, as determined by the study PI
  • Have a current diagnosis of cancer, liver or kidney disease, gastrointestinal diseases (including Celiac, Crohn's, Ulcerative Colitis), and cardiometabolic disorders (cardiovascular disease, diabetes, etc.)
  • Are pregnant or breastfeeding, or actively trying to lose weight
  • Use excessive alcohol
  • Use of supplements containing probiotics at any dose or if you are participating in other studies that may interfere with the bacteria in your gut.
  • Unable or unwilling to consume capsules, provide stool or blood samples, track bowel movements and symptoms, and attend scheduled clinic visits.
  • Have allergies to study treatments or medical supplies (eg. Latex, yeast, cellulose)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80521, United States

Location

Central Study Contacts

Tiffany L Weir, PhD

CONTACT

970-215-7571tiffany.weir@colostate.edu

Jenny Whittington, MS

CONTACT

970-310-6843ijwhitt@rams.colostate.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 9, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)