Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo capsule 40 subjects allocated to daily placebo capsule for 10 weeks |
Dietary Supplement: Placebo
Daily placebo for 10 weeks
Other Names:
|
| Experimental: Trenev Trio®/Healthy Trinity® 80 subjects allocated to Trenev Trio®/Healthy Trinity® for 10 weeks |
Dietary Supplement: Trenev 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)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean total Gastrointestinal Symptom Rating Scale (GSRS) score [10 weeks]
- Gastrointestinal Quality of Life Index (GIQLI) total score [10 weeks]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Axis Clinical Trials | Los Angeles | California | United States | 90036 |
| 2 | Sprim ALS | San Francisco | California | United States | 94109 |
| 3 | Research Across America | West Lawn | Pennsylvania | United States | 19609 |
| 4 | Research Across America | Carrollton | Texas | United States | 75010 |
| 5 | Clinical Research Associates of Tidewater | Norfolk | Virginia | United States | 23507 |
Sponsors and Collaborators
- Sprim Advanced Life Sciences
- The National Institute of Probiotics
Investigators
- Principal Investigator: Duane Wombolt, MD, Clinical Research Associates of Tidewater
- Principal Investigator: Jeffrey Stewart, MD, Research Across America
- Principal Investigator: Michael Sinitsa, MD, Research Across America
- Principal Investigator: Helen Stacey, MD, Diablo Clinical Research
- Principal Investigator: Lydie Hazan, MD, Axis Clinical Trials
- Principal Investigator: JoAnn Hattner, MPH, RD, Sprim ALS
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 110725-SUS-NIP-GIS-RA