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Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms

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ClinicalTrials.gov Identifier: NCT02277431
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : October 29, 2015
Sponsor:
Information provided by (Responsible Party):
Chris D'Adamo, University of Maryland, College Park

Tracking Information
First Submitted Date  ICMJE October 24, 2014
First Posted Date  ICMJE October 29, 2014
Last Update Posted Date October 29, 2015
Study Start Date  ICMJE December 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2014)
  • Severity of self-reported bloating [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale
  • Severity of self-reported gas [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale
  • Severity of self-reported indigestion [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale
  • Severity of self-reported abdominal pain [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale
  • Severity of self-reported defecation irregularity [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2014)
  • Frequency of self-reported bloating [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale
  • Frequency of self-reported gas [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale
  • Frequency of self-reported indigestion [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale
  • Frequency of self-reported abdominal pain [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale
  • Frequency of self-reported defecation irregularity [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 28, 2014)
  • Gastrointestinal Symptom Rating Scale [ Time Frame: Study end (6 weeks from baseline) ]
  • Gastrointestinal Quality of Life Index [ Time Frame: Study end (6 weeks from baseline) ]
  • Bristol Stool Scale [ Time Frame: Study end (6 weeks from baseline) ]
  • Rescue medication usage [ Time Frame: Study end (6 weeks from baseline) ]
  • Adequate relief [ Time Frame: Study end (6 weeks from baseline) ]
    "In the past 7 days, have you had adequate relief of your gastrointestinal discomfort?"
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms
Official Title  ICMJE A Randomized Controlled Trial of a Commercially-Available Probiotic Supplement (Trenev Trio®/Healthy Trinity®) and the Promotion of Normal Gastrointestinal Function Among Adults With Recurrent Gastrointestinal Symptoms
Brief Summary Participants experiencing recurrent gastrointestinal symptoms in this double-blind, randomized, controlled trial will receive either a commercially-available probiotic dietary supplement or placebo. The investigators hypothesize that participants in the probiotic dietary supplement group will experience greater improvement in their gastrointestinal symptoms than participants in the placebo group.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE
  • Gastrointestinal Symptoms
  • Bloating
  • Gas
  • Indigestion
  • Abdominal Pain
  • Defecation Irregularity
Intervention  ICMJE
  • Dietary Supplement: Probiotic dietary supplement (Trenev Trio®)

    Trenev Trio® (healthcare professional line)/Healthy Trinity® (consumer line) is a dietary supplement that contains probiotics microenrobed in an oil matrix in a two-piece hard gel capsule. One capsule will be taken twice per day (am & pm) offering a total daily serving of:

    • Lactobacillus acidophilus NAS super strain (10 billion Colony Forming Units [CFU])
    • Bifidobacterium bifidum Malyoth super strain (40 billion CFU)
    • Lactobacillus delbrueckii subspecies bulgaricus LB-51 super strain (10 billion CFU)
  • Dietary Supplement: placebo
Study Arms  ICMJE
  • Experimental: Probiotic dietary supplement

    Trenev Trio® (healthcare professional line)/Healthy Trinity® (consumer line) is a dietary supplement that contains probiotics microenrobed in an oil matrix in a two-piece hard gel capsule. One capsule will be taken twice per day (am & pm) offering a total daily serving of:

    • Lactobacillus acidophilus NAS super strain (10 billion Colony Forming Units [CFU])
    • Bifidobacterium bifidum Malyoth super strain (40 billion CFU)
    • Lactobacillus delbrueckii subspecies bulgaricus LB-51 super strain (10 billion CFU)
    Intervention: Dietary Supplement: Probiotic dietary supplement (Trenev Trio®)
  • Placebo Comparator: Placebo
    The placebo capsules utilized in this study will be indistinguishable from the probiotic dietary supplement capsules as they will be identical in appearance, odor, weight, and taste. Furthermore, the same sunflower oil matrix will be in both the probiotic dietary supplement and placebo. The only difference between the dietary supplement and placebo capsules will be the probiotic bacteria.
    Intervention: Dietary Supplement: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2014)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Self-reported response of "moderate discomfort" or worse (3 or greater on 1-5 Likert Scale) and "frequent discomfort" or more often (3 or greater on 1-5 Likert scale) from at least 2 of the following gastrointestinal symptoms: gas, indigestion, bloating, abdominal pain, or defecation irregularity as expressed on Likert scale (1=very minor or no discomfort, 2=minor discomfort, 3=moderate discomfort, 4=high discomfort, 5=very high discomfort) over the previous 3 weeks
  2. Agree to continue with typical diet and exercise habits during study
  3. Agree to use contraception or abstinence throughout study period, unless postmenopausal or surgically sterile (females only)
  4. Able to understand and voluntarily consent to the study and understand its nature and purpose including potential risks and side effects

Exclusion Criteria:

  1. Current and documented diagnosis of Inflammatory Bowel Disease (Crohn's disease or ulcerative colitis), Celiac disease, active peptic ulcer, active diverticulitis, and other active cases of gastrointestinal diseases that, in the investigators' opinions, may affect participant safety.
  2. Current and documented diagnosis of any other non-gastrointestinal disease that, in the investigators' opinions, may affect participant safety or confound the evaluation of the study outcomes. Excluded conditions include congestive heart failure, malignancy, uncontrolled diabetes mellitus, uncontrolled autoimmune disease (lupus, rheumatoid arthritis, eczema), eating disorders, and any other active health condition or disease that the investigators feel contradict the intended study population of participants in good health.
  3. Daily consumption of another probiotic supplement or new consumption of fermented dairy products (yogurt, kefir, etc.)
  4. Usage of systemic steroids during the past 2 months
  5. Usage of antipsychotic medications during the past 2 months
  6. Usage of prednisone, 6-mercaptopurine, adalimumab, etanercept, infliximab, leflunomide, golimumab, or mycophenolate mofetil during the past 2 months
  7. Uncontrolled anxiety or current medication for anxiety disorder
  8. Pregnant or breastfeeding females
  9. History of alcohol, drug, or medication abuse
  10. Known allergies to any substance in the study product
  11. Previous major gastrointestinal tract surgery (colon resection, gastric bypass, etc.)
  12. Participation in another clinical trial within 30 days of screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02277431
Other Study ID Numbers  ICMJE 00007145
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chris D'Adamo, University of Maryland, College Park
Study Sponsor  ICMJE University of Maryland, College Park
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chris D'Adamo, PhD University of Maryland, College Park
PRS Account University of Maryland, Baltimore
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP