Status:
UNKNOWN
Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms
Lead Sponsor:
Sprim Advanced Life Sciences
Collaborating Sponsors:
The National Institute of Probiotics
Conditions:
Recurrent Gastrointestinal Symptoms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01444859
Start Date
February 1 2012
End Date
November 1 2012
Last Update
October 24 2012
Active Locations (5)
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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