Clinical trial NCT01444859: Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Recurrent Gastrointestinal Symptoms
Lead sponsor: Sprim Advanced Life Sciences
Sponsor class: OTHER
Collaborators: name: The National Institute of Probiotics
First posted: 2011-10-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean total Gastrointestinal Symptom Rating Scale (GSRS) score
timeFrame: 10 weeks
measure: Gastrointestinal Quality of Life Index (GIQLI) total score
timeFrame: 10 weeks
Secondary outcomes:
measure: Gastrointestinal Symptom Rating Scale subscores
timeFrame: 10 weeks
measure: Gas severity
timeFrame: 10 weeks
measure: Bloating severity
timeFrame: 10 weeks
measure: Acid indigestion severity
timeFrame: 10 weeks
measure: Abdominal cramping severity
timeFrame: 10 weeks
measure: Stool consistency (measured with Bristol Stool Form Scale)
timeFrame: 10 weeks
measure: Stool frequency
timeFrame: 10 weeks
measure: Concomitant medication use
timeFrame: 10 weeks
measure: Adverse event frequency
timeFrame: 10 weeks
measure: Adverse event severity
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: San Francisco
country: United States
facility: Sprim ALS
state: California
city: West Lawn
country: United States
facility: Research Across America
state: Pennsylvania
city: Carrollton
country: United States
facility: Research Across America
state: Texas
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
Study officials:
affiliation: Clinical Research Associates of Tidewater
name: Duane Wombolt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Across America
name: Jeffrey Stewart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Across America
name: Michael Sinitsa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diablo Clinical Research
name: Helen Stacey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Axis Clinical Trials
name: Lydie Hazan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sprim ALS
name: JoAnn Hattner, MPH, RD
role: PRINCIPAL_INVESTIGATOR
References: