Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms

This study is a double-blind, randomized, placebo-controlled, parallel group trial comparing
the safety and effectiveness of supplementation with Trenev Trio®/Healthy Trinity® vs.
placebo in otherwise healthy subjects with recurrent gastrointestinal symptoms. Subjects
will be recruited and, following successful completion of a 2-week run-in period, will be
randomized to Trenev Trio®/Healthy Trinity® or placebo and will consume their assigned study
product daily for 10 weeks. The study endpoints of this trial include relief of overall
gastrointestinal symptoms, acid indigestion, abdominal cramping, constipation, diarrhea,
gas, and bloating as well as product safety over the 10-week supplementation period.

Inclusion Criteria:

1. Age ≥18 years

2. Body mass index between 18.5 through 39.9 kg/m2

3. At least three symptoms rated between 4 to 6 in severity (moderate to severe
discomfort) on a 1 to 7 scale, one of which must be acid indigestion as determined by
the "Reflux Syndrome" score

4. Self-reported "acid indigestion" symptoms (including pain/discomfort beneath the
breastbone, bitter fluid in the mouth, or bloating/nausea after eating) at least 3
times per week over the previous 4 weeks

5. Agree to use contraception throughout study period, unless postmenopausal or
surgically sterile (females only)

6. Able to understand and voluntarily consent to the study and understand it's nature
and purpose including potential risks, and side effects

Exclusion Criteria:

1. Any GSRS symptom rated a 7 in severity (very severe discomfort) on a 1 to 7 scale

2. Diagnosed gastrointestinal disease/complication or functional bowel disorder (e.g.
IBS, functional constipation, IBD, ulcer, etc.) based on physical examination or
documented medical history that, in the investigator's opinion, may affect subject
safety or confound the evaluation of the study endpoints

3. Any non-gastrointestinal disease/complication that, in the investigator's opinion,
may affect subject safety or confound the evaluation of the study endpoints

4. Regular (>3 days per week) prescription medication use for any gastrointestinal
disease/condition

5. Recent (<6 months) abdominal surgery for any reason

6. Immunodeficiency

7. Recent change in anti-psychotic medication within the previous 3 months

8. Systemic steroid use within the prior month, excluding regular use of asthma
medication

9. Pregnant female or breastfeeding

10. Eating disorder

11. Recent (within 2 weeks) antibiotic administration

12. History of alcohol, drug, or medication abuse

13. Daily consumption of probiotics, fermented milk, and/or yogurt

14. Known allergies to any substance in the study product

15. Participation in another study with any investigational product within 30 days of
screening