Recurrent Gastrointestinal Symptoms Clinical Trial
Official title:
Effect of Trenev Trio®/Healthy Trinity® in Otherwise Healthy Adults With Recurrent Gastrointestinal Symptoms: a Double-blind, Randomized, Placebo-controlled, Parallel Group Study
| Verified date | December 2011 |
| Source | Sprim Advanced Life Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 120 |
| Est. completion date | November 2012 |
| Est. primary completion date | August 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Across America | Carrollton | Texas |
| United States | Axis Clinical Trials | Los Angeles | California |
| United States | Clinical Research Associates of Tidewater | Norfolk | Virginia |
| United States | Sprim ALS | San Francisco | California |
| United States | Research Across America | West Lawn | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Sprim Advanced Life Sciences | The National Institute of Probiotics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean total Gastrointestinal Symptom Rating Scale (GSRS) score | 10 weeks | No | |
| Primary | Gastrointestinal Quality of Life Index (GIQLI) total score | 10 weeks | No | |
| Secondary | Gastrointestinal Symptom Rating Scale subscores | 10 weeks | No | |
| Secondary | Gas severity | 10 weeks | No | |
| Secondary | Bloating severity | 10 weeks | No | |
| Secondary | Acid indigestion severity | 10 weeks | No | |
| Secondary | Abdominal cramping severity | 10 weeks | No | |
| Secondary | Stool consistency (measured with Bristol Stool Form Scale) | 10 weeks | No | |
| Secondary | Stool frequency | 10 weeks | No | |
| Secondary | Concomitant medication use | 10 weeks | No | |
| Secondary | Adverse event frequency | 10 weeks | Yes | |
| Secondary | Adverse event severity | 10 weeks | Yes |