Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms

Study Overview
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Brief Summary
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Participants experiencing recurrent gastrointestinal symptoms in this double-blind, randomized, controlled trial will receive either a commercially-available probiotic dietary supplement or placebo. The investigators hypothesize that participants in the probiotic dietary supplement group will experience greater improvement in their gastrointestinal symptoms than participants in the placebo group.

Official Title
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A Randomized Controlled Trial of a Commercially-Available Probiotic Supplement (Trenev Trio®/Healthy Trinity®) and the Promotion of Normal Gastrointestinal Function Among Adults With Recurrent Gastrointestinal Symptoms

Conditions
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Gastrointestinal Symptoms, Bloating, Gas, Indigestion, Abdominal Pain, Defecation Irregularity

Intervention / Treatment
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* Dietary Supplement: Probiotic dietary supplement (Trenev Trio®)
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported response of moderate discomfort or worse (3 or greater on 1-5 Likert Scale) and frequent discomfort or more often (3 or greater on 1-5 Likert scale) from at least 2 of the following gastrointestinal symptoms: gas, indigestion, bloating, abdominal pain, or defecation irregularity as expressed on Likert scale (1=very minor or no discomfort, 2=minor discomfort, 3=moderate discomfort, 4=high discomfort, 5=very high discomfort) over the previous 3 weeks Agree to continue with typical diet and exercise habits during study Agree to use contraception or abstinence throughout study period, unless postmenopausal or surgically sterile (females only) Able to understand and voluntarily consent to the study and understand its nature and purpose including potential risks and side effects Exclusion Criteria: Current and documented diagnosis of Inflammatory Bowel Disease (Crohn's disease or ulcerative colitis), Celiac disease, active peptic ulcer, active diverticulitis, and other active cases of gastrointestinal diseases that, in the investigators' opinions, may affect participant safety. Current and documented diagnosis of any other non-gastrointestinal disease that, in the investigators' opinions, may affect participant safety or confound the evaluation of the study outcomes. Excluded conditions include congestive heart failure, malignancy, uncontrolled diabetes mellitus, uncontrolled autoimmune disease (lupus, rheumatoid arthritis, eczema), eating disorders, and any other active health condition or disease that the investigators feel contradict the intended study population of participants in good health. Daily consumption of another probiotic supplement or new consumption of fermented dairy products (yogurt, kefir, etc.) Usage of systemic steroids during the past 2 months Usage of antipsychotic medications during the past 2 months Usage of prednisone, 6-mercaptopurine, adalimumab, etanercept, infliximab, leflunomide, golimumab, or mycophenolate mofetil during the past 2 months Uncontrolled anxiety or current medication for anxiety disorder Pregnant or breastfeeding females History of alcohol, drug, or medication abuse Known allergies to any substance in the study product Previous major gastrointestinal tract surgery (colon resection, gastric bypass, etc.) Participation in another clinical trial 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic dietary supplement<br>Trenev Trio® (healthcare professional line)/Healthy Trinity® (consumer line) is a dietary supplement that contains probiotics microenrobed in an oil matrix in a two-piece hard gel capsule. One capsule will be taken twice per day (am & pm) offering a total daily serving of: Lactobacillus acidophilus NAS super strain (10 billion Colony Forming Units [CFU]) Bifidobacterium bifidum Malyoth super strain (40 billion CFU) Lactobacillus delbrueckii subspecies bulgaricus LB-51 super strain (10 billion CFU) | Dietary Supplement: Probiotic dietary supplement (Trenev Trio®)<br>* Trenev Trio® (healthcare professional line)/Healthy Trinity® (consumer line) is a dietary supplement that contains probiotics microenrobed in an oil matrix in a two-piece hard gel capsule. One capsule will be taken twice per day (am & pm) offering a total daily serving of: Lactobacillus acidophilus NAS super strain (10 billion Colony Forming Units [CFU]) Bifidobacterium bifidum Malyoth super strain (40 billion CFU) Lactobacillus delbrueckii subspecies bulgaricus LB-51 super strain (10 billion CFU)<br>|
| Placebo Comparator: Placebo<br>The placebo capsules utilized in this study will be indistinguishable from the probiotic dietary supplement capsules as they will be identical in appearance, odor, weight, and taste. Furthermore, the same sunflower oil matrix will be in both the probiotic dietary supplement and placebo. The only difference between the dietary supplement and placebo capsules will be the probiotic bacteria. | Dietary Supplement: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of self-reported bloating | Likert scale | Study end (6 weeks from baseline) | 
| Severity of self-reported gas | Likert scale | Study end (6 weeks from baseline) | 
| Severity of self-reported indigestion | Likert scale | Study end (6 weeks from baseline) | 
| Severity of self-reported abdominal pain | Likert scale | Study end (6 weeks from baseline) | 
| Severity of self-reported defecation irregularity | Likert scale | Study end (6 weeks from baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of self-reported bloating | Likert scale | Study end (6 weeks from baseline) | 
| Frequency of self-reported gas | Likert scale | Study end (6 weeks from baseline) | 
| Frequency of self-reported indigestion | Likert scale | Study end (6 weeks from baseline) | 
| Frequency of self-reported abdominal pain | Likert scale | Study end (6 weeks from baseline) | 
| Frequency of self-reported defecation irregularity | Likert scale | Study end (6 weeks from baseline) |