Recurrent Gastrointestinal Symptoms
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
Daily placebo for 10 weeks
DIETARY_SUPPLEMENTTrenev Trio®/Healthy Trinity®
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)
Sponsors
The National Institute of Probiotics
Sprim Advanced Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean total Gastrointestinal Symptom Rating Scale (GSRS) score | 10 weeks |
| Gastrointestinal Quality of Life Index (GIQLI) total score | 10 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Bloating severity | 10 weeks |
| Acid indigestion severity | 10 weeks |
| Abdominal cramping severity | 10 weeks |
| Stool consistency (measured with Bristol Stool Form Scale) | 10 weeks |
| Gastrointestinal Symptom Rating Scale subscores | 10 weeks |
| Concomitant medication use | 10 weeks |
| Adverse event frequency | 10 weeks |
| Adverse event severity | 10 weeks |
| Stool frequency | 10 weeks |
| Gas severity | 10 weeks |
Countries
United States
Outcome results
None listed