Health TrialsbyHealthPanel

Exploration of Tolerability and Dose Responses for a Yeast-based Probiotic

ConditionsHealthy Adult ParticipantsGut Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorColorado State University

About 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 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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

between 18-75 years old

BMI <30 kg/m2

mild/moderate gastrointestinal distress

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 9.9 x 10^7 Pichia kluyveri PK88

    Dietary supplement

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

  • 1 x 10^8 Pichia kluyveri PK88

    Dietary supplement

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

  • Placebo

    Dietary supplement

    Placebo - cellulose and hypromellose

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: Pichia kluyveri 9.9 x 10^7Experimental treatment 1 intervention
Group B: Pichia kluyveri 1 x 10^8Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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"

Time frame
4 weeks

Secondary outcomes

1

Tumor Necrosis Factor Alpha

Tumor necrosis factor alpha, or TNF-a, is an inflammatory cytokine that is implicated in many diseases.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Colorado State University

Lead sponsor

Biohm Technologies

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: