Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms

Effect of Trenev Trio®/Healthy Trinity® in Otherwise Healthy Adults With Recurrent Gastrointestinal Symptoms: a Double-blind, Randomized, Placebo-controlled, Parallel Group Study

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.

Study Overview

• Status: Unknown
• Conditions: Recurrent Gastrointestinal Symptoms
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Trenev Trio®/Healthy Trinity®

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trials
    • San Francisco, California, United States, 94109
      • Sprim ALS
  • Pennsylvania
    • West Lawn, Pennsylvania, United States, 19609
      • Research Across America
  • Texas
    • Carrollton, Texas, United States, 75010
      • Research Across America
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Clinical Research Associates of Tidewater

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo capsule; 40 subjects allocated to daily placebo capsule for 10 weeks	Dietary supplement: Placebo; Daily placebo for 10 weeks; Other Names: Control; Inactive
Experimental: Trenev Trio®/Healthy Trinity®; 80 subjects allocated to Trenev Trio®/Healthy Trinity® for 10 weeks	Dietary supplement: 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); Other Names: Active; Probiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean total Gastrointestinal Symptom Rating Scale (GSRS) score	10 weeks
Gastrointestinal Quality of Life Index (GIQLI) total score	10 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sprim Advanced Life Sciences
• Collaborators: The National Institute of Probiotics
• Investigators: Principal Investigator: Lydie Hazan, MD, Axis Clinical Trials; Principal Investigator: Jeffrey Stewart, MD, Research Across America; Principal Investigator: Michael Sinitsa, MD, Research Across America; Principal Investigator: Helen Stacey, MD, Diablo Clinical Research; Principal Investigator: JoAnn Hattner, MPH, RD, Sprim ALS

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Anticipated): November 1, 2012

Study Registration Dates

• First Submitted: September 28, 2011
• First Submitted That Met QC Criteria: September 29, 2011
• First Posted (Estimate): October 3, 2011

Study Record Updates

• Last Update Posted (Estimate): October 24, 2012
• Last Update Submitted That Met QC Criteria: October 23, 2012
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: 110725-SUS-NIP-GIS-RA