Overview

This trial is active, not recruiting.

Condition recurrent gastrointestinal symptoms
Treatments trenev trio®/healthy trinity®, placebo
Phase phase 2/phase 3
Sponsor Sprim Advanced Life Sciences
Collaborator The National Institute of Probiotics
Start date February 2012
End date August 2012
Trial size 120 participants
Trial identifier NCT01444859, 110725-SUS-NIP-GIS-RA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
40 subjects allocated to daily placebo capsule for 10 weeks
placebo Inactive
Daily placebo for 10 weeks
(Experimental)
80 subjects allocated to Trenev Trio®/Healthy Trinity® for 10 weeks
trenev trio®/healthy trinity® Probiotic
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)

Primary Outcomes

Measure
Mean total Gastrointestinal Symptom Rating Scale (GSRS) score
time frame: 10 weeks
Gastrointestinal Quality of Life Index (GIQLI) total score
time frame: 10 weeks

Secondary Outcomes

Measure
Gastrointestinal Symptom Rating Scale subscores
time frame: 10 weeks
Gas severity
time frame: 10 weeks
Bloating severity
time frame: 10 weeks
Acid indigestion severity
time frame: 10 weeks
Abdominal cramping severity
time frame: 10 weeks
Stool consistency (measured with Bristol Stool Form Scale)
time frame: 10 weeks
Stool frequency
time frame: 10 weeks
Concomitant medication use
time frame: 10 weeks
Adverse event frequency
time frame: 10 weeks
Adverse event severity
time frame: 10 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Duane Wombolt, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Sprim Advanced Life Sciences.