Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms - Full Text View

Purpose

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.

Condition	Intervention	Phase
Recurrent Gastrointestinal Symptoms	Dietary Supplement: Trenev Trio®/Healthy Trinity® Dietary Supplement: Placebo	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Further study details as provided by Sprim Advanced Life Sciences:

Primary Outcome Measures:

Mean total Gastrointestinal Symptom Rating Scale (GSRS) score [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Gastrointestinal Quality of Life Index (GIQLI) total score [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Gastrointestinal Symptom Rating Scale subscores [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Gas severity [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Bloating severity [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Acid indigestion severity [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Abdominal cramping severity [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Stool consistency (measured with Bristol Stool Form Scale) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Stool frequency [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Concomitant medication use [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Adverse event frequency [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
Adverse event severity [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	February 2012
Estimated Study Completion Date:	November 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo capsule 40 subjects allocated to daily placebo capsule for 10 weeks	Dietary Supplement: Placebo Daily placebo for 10 weeks Other Names: Inactive Control
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: Probiotic Active

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444859

Locations

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

Sponsors and Collaborators

Sprim Advanced Life Sciences

The National Institute of Probiotics

Investigators

Principal Investigator:	Duane Wombolt, MD	Clinical Research Associates of Tidewater
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:	Lydie Hazan, MD	Axis Clinical Trials
Principal Investigator:	JoAnn Hattner, MPH, RD	Sprim ALS

More Information

No publications provided

Responsible Party:	Sprim Advanced Life Sciences
ClinicalTrials.gov Identifier:	NCT01444859 History of Changes
Other Study ID Numbers:	110725-SUS-NIP-GIS-RA
Study First Received:	September 28, 2011
Last Updated:	October 23, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Gastrointestinal Diseases
Signs and Symptoms, Digestive
Digestive System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013