Abdominal Pain, Bloating, Defecation Irregularity, Gas, Gastrointestinal Symptoms, Indigestion
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTProbiotic dietary supplement (Trenev Trio®)
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_SUPPLEMENTplacebo
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 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 2. Agree to continue with typical diet and exercise habits during study 3. Agree to use contraception or abstinence throughout study period, unless postmenopausal or surgically sterile (females only) 4. Able to understand and voluntarily consent to the study and understand its nature and purpose including potential risks and side effects
Exclusion criteria
1. 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. 2. 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. 3. Daily consumption of another probiotic supplement or new consumption of fermented dairy products (yogurt, kefir, etc.) 4. Usage of systemic steroids during the past 2 months 5. Usage of antipsychotic medications during the past 2 months 6. Usage of prednisone, 6-mercaptopurine, adalimumab, etanercept, infliximab, leflunomide, golimumab, or mycophenolate mofetil during the past 2 months 7. Uncontrolled anxiety or current medication for anxiety disorder 8. Pregnant or breastfeeding females 9. History of alcohol, drug, or medication abuse 10. Known allergies to any substance in the study product 11. Previous major gastrointestinal tract surgery (colon resection, gastric bypass, etc.) 12. Participation in another clinical trial within 30 days of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of self-reported defecation irregularity | Study end (6 weeks from baseline) | Likert scale |
| Severity of self-reported abdominal pain | Study end (6 weeks from baseline) | Likert scale |
| Severity of self-reported bloating | Study end (6 weeks from baseline) | Likert scale |
| Severity of self-reported indigestion | Study end (6 weeks from baseline) | Likert scale |
| Severity of self-reported gas | Study end (6 weeks from baseline) | Likert scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of self-reported indigestion | Study end (6 weeks from baseline) | Likert scale |
| Frequency of self-reported bloating | Study end (6 weeks from baseline) | Likert scale |
| Frequency of self-reported gas | Study end (6 weeks from baseline) | Likert scale |
| Frequency of self-reported abdominal pain | Study end (6 weeks from baseline) | Likert scale |
| Frequency of self-reported defecation irregularity | Study end (6 weeks from baseline) | Likert scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Symptom Rating Scale | Study end (6 weeks from baseline) | — |
| Adequate relief | Study end (6 weeks from baseline) | In the past 7 days, have you had adequate relief of your gastrointestinal discomfort? |
| Rescue medication usage | Study end (6 weeks from baseline) | — |
| Bristol Stool Scale | Study end (6 weeks from baseline) | — |
| Gastrointestinal Quality of Life Index | Study end (6 weeks from baseline) | — |
Outcome results
None listed