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Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Sprim Advanced Life Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
The National Institute of Probiotics
Information provided by (Responsible Party):
Sprim Advanced Life Sciences
ClinicalTrials.gov Identifier:
NCT01444859
First received: September 28, 2011
Last updated: October 23, 2012
Last verified: December 2011
  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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 24, 2014