Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms

Study Overview
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Brief Summary
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Clinical trial to compare safety and effectiveness of 10-week supplementation with Trenev Trio®/Healthy Trinity® vs. placebo in otherwise healthy subjects with recurrent gastrointestinal symptoms.

Detailed Description
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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.

Official Title
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Effect of Trenev Trio®/Healthy Trinity® in Otherwise Healthy Adults With Recurrent Gastrointestinal Symptoms: a Double-blind, Randomized, Placebo-controlled, Parallel Group Study

Conditions
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Recurrent Gastrointestinal Symptoms

Intervention / Treatment
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* Dietary Supplement: Trenev Trio®/Healthy Trinity®
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Body mass index between 18.5 through 39.9 kg/m2 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 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 Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only) Able to understand and voluntarily consent to the study and understand it's nature and purpose including potential risks, and side effects Exclusion Criteria: Any GSRS symptom rated a 7 in severity (very severe discomfort) on a 1 to 7 scale 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 Any non-gastrointestinal disease/complication that, in the investigator's opinion, may affect subject safety or confound the evaluation of the study endpoints Regular (>3 days per week) prescription medication use for any gastrointestinal disease/condition Recent (<6 months) abdominal surgery for any reason Immunodeficiency Recent change in anti-psychotic medication within the previous 3 months Systemic steroid use within the prior month, excluding regular use of asthma medication Pregnant female or breastfeeding Eating disorder Recent (within 2 weeks) antibiotic administration History of alcohol, drug, or medication abuse Daily consumption of probiotics, fermented milk, and/or yogurt Known allergies to any substance in the study product Participation in another study with any investigational product within 30 days of screening

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo capsule<br>40 subjects allocated to daily placebo capsule for 10 weeks | Dietary Supplement: Placebo<br>* Daily placebo for 10 weeks<br>* Other names: Control;|
| Experimental: Trenev Trio®/Healthy Trinity®<br>80 subjects allocated to Trenev Trio®/Healthy Trinity® for 10 weeks | Dietary Supplement: Trenev Trio®/Healthy Trinity®<br>* Trenev Trio®/Healthy Trinity® (1 capsule, 2x/day for 10 weeks), which offers a daily dose of: a) Lactobacillus acidophilus NAS strain (10 billion CFU), b) Bifidobacterium bifidum Malyoth strain (40 billion CFU), and c) Lactobacillus delbrueckii subspecies bulgaricus LB-51 strain (10 billion CFU)<br>* Other names: Active;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean total Gastrointestinal Symptom Rating Scale (GSRS) score |  | 10 weeks | 
| Gastrointestinal Quality of Life Index (GIQLI) total score |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Symptom Rating Scale subscores |  | 10 weeks | 
| Gas severity |  | 10 weeks | 
| Bloating severity |  | 10 weeks | 
| Acid indigestion severity |  | 10 weeks | 
| Abdominal cramping severity |  | 10 weeks | 
| Stool consistency (measured with Bristol Stool Form Scale) |  | 10 weeks | 
| Stool frequency |  | 10 weeks | 
| Concomitant medication use |  | 10 weeks | 
| Adverse event frequency |  | 10 weeks | 
| Adverse event severity |  | 10 weeks |