Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms

Status unconfirmed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Recurrent Gastrointestinal Symptoms

In brief

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.

Key facts

Study ID

NCT01444859

Run by

Sprim Advanced Life Sciences

People needed

120

Starts

2012-02-01

Expected to finish

2012-11-01

Last updated by the study team

2012-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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