Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms
NCT ID: NCT01444859
Last Updated: 2012-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2012-02-29
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo capsule
40 subjects allocated to daily placebo capsule for 10 weeks
Placebo
Daily placebo for 10 weeks
Trenev Trio®/Healthy Trinity®
80 subjects allocated to Trenev Trio®/Healthy Trinity® for 10 weeks
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)
Interventions
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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)
Placebo
Daily placebo for 10 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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The National Institute of Probiotics
OTHER
Sprim Advanced Life Sciences
OTHER
Responsible Party
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Principal Investigators
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Duane Wombolt, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Associates of Tidewater
Jeffrey Stewart, MD
Role: PRINCIPAL_INVESTIGATOR
Research Across America
Michael Sinitsa, MD
Role: PRINCIPAL_INVESTIGATOR
Research Across America
Helen Stacey, MD
Role: PRINCIPAL_INVESTIGATOR
Diablo Clinical Research
Lydie Hazan, MD
Role: PRINCIPAL_INVESTIGATOR
Axis Clinical Trials
JoAnn Hattner, MPH, RD
Role: PRINCIPAL_INVESTIGATOR
Sprim ALS
Locations
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Axis Clinical Trials
Los Angeles, California, United States
Sprim ALS
San Francisco, California, United States
Research Across America
West Lawn, Pennsylvania, United States
Research Across America
Carrollton, Texas, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Countries
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Other Identifiers
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110725-SUS-NIP-GIS-RA
Identifier Type: -
Identifier Source: org_study_id