This is a Phase II and III clinical trial of probiotics for recurrent gastrointestinal symptoms.  Some people already on medicine might not qualify, but others might.  I'm not recommending this to anyone, but if you think the shoe fits....

     
     
Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms
This study is currently recruiting participants.
Verified on December 2011 by Sprim Advanced Life Sciences

First Received on September 28, 2011.   Last Updated on December 19, 2011   History of Changes
Sponsor:       Sprim Advanced Life Sciences
Collaborator:       The National Institute of Probiotics
Information provided by (Responsible Party):      Sprim Advanced Life Sciences
ClinicalTrials.gov Identifier:      NCT01444859
 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 II
Phase III

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:      October 2011
Estimated Study Completion Date:      August 2012
Estimated Primary Completion Date:      May 2012 (Final data collection date for primary outcome measure)
Arms       Assigned Interventions
Placebo capsule: Placebo Comparator
40 subjects allocated to daily placebo capsule for 10 weeks
Intervention: Dietary Supplement: Placebo
Dietary Supplement: Placebo
Daily placebo for 10 weeks
Other Names:
Inactive
Control
Trenev Trio®/Healthy Trinity®: Experimental
80 subjects allocated to Trenev Trio®/Healthy Trinity® for 10 weeks
Intervention: Dietary Supplement: Trenev Trio®/Healthy Trinity®
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

Contacts
Contact: Xander Baroque            xander.baroque@sprim.com

Locations
United States, Virginia
Clinical Research Associates of Tidewater      Recruiting
Norfolk, Virginia, United States, 23507
Contact: Duane Wombolt, MD     757-627-7446     dwombolt@crat.org    
Sponsors and Collaborators
Sprim Advanced Life Sciences
The National Institute of Probiotics
Investigators
Principal Investigator:      Duane Wombolt, MD      Clinical Research Associates of Tidewater
 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:      December 19, 2011
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 January 10, 2012