Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms

NCT01444859 | Unknown Phase 2

• 1 other identifier: 110725-SUS-NIP-GIS-RA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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.

Conditions

Recurrent Gastrointestinal Symptoms

Outcome Measures

Primary Outcomes (2)

• Mean total Gastrointestinal Symptom Rating Scale (GSRS) score

  10 weeks

• Gastrointestinal Quality of Life Index (GIQLI) total score

  10 weeks

Secondary Outcomes (10)

• 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

Study Arms (2)

Placebo capsule

PLACEBO COMPARATOR

40 subjects allocated to daily placebo capsule for 10 weeks

Dietary Supplement: Placebo

Trenev Trio®/Healthy Trinity®

EXPERIMENTAL

80 subjects allocated to Trenev Trio®/Healthy Trinity® for 10 weeks

Dietary Supplement: Trenev Trio®/Healthy Trinity®

Interventions

Trenev Trio®/Healthy Trinity® DIETARY_SUPPLEMENT

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)

Also known as: Probiotic, Active

Trenev Trio®/Healthy Trinity®

Placebo DIETARY_SUPPLEMENT

Daily placebo for 10 weeks

Also known as: Inactive, Control

Placebo capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sprim Advanced Life Sciences: lead
• The National Institute of Probiotics: collaborator

Study Sites (5)

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

Sprim ALS

San Francisco, California, 94109, United States

Location

Research Across America

West Lawn, Pennsylvania, 19609, United States

Location

Research Across America

Carrollton, Texas, 75010, United States

Location

Clinical Research Associates of Tidewater

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Interventions

Probiotics; Exercise

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2011
• First Posted: October 3, 2011
• Study Start: February 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 24, 2012

Record last verified: 2011-12

Locations

US (5)