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Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms

Primary Purpose

Gastrointestinal Symptoms, Bloating, Gas

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Probiotic dietary supplement (Trenev Trio®)
placebo
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gastrointestinal Symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Probiotic dietary supplement

    Placebo

    Arm Description

    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)

    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.

    Outcomes

    Primary Outcome Measures

    Severity of self-reported bloating
    Likert scale
    Severity of self-reported gas
    Likert scale
    Severity of self-reported indigestion
    Likert scale
    Severity of self-reported abdominal pain
    Likert scale
    Severity of self-reported defecation irregularity
    Likert scale

    Secondary Outcome Measures

    Frequency of self-reported bloating
    Likert scale
    Frequency of self-reported gas
    Likert scale
    Frequency of self-reported indigestion
    Likert scale
    Frequency of self-reported abdominal pain
    Likert scale
    Frequency of self-reported defecation irregularity
    Likert scale

    Full Information

    First Posted
    October 24, 2014
    Last Updated
    September 6, 2021
    Sponsor
    University of Maryland, Baltimore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02277431
    Brief Title
    Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Maryland, Baltimore

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastrointestinal Symptoms, Bloating, Gas, Indigestion, Abdominal Pain, Defecation Irregularity

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotic dietary supplement
    Arm Type
    Experimental
    Arm Description
    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)
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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 Type
    Dietary Supplement
    Intervention Name(s)
    Probiotic dietary supplement (Trenev Trio®)
    Intervention Description
    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 Type
    Dietary Supplement
    Intervention Name(s)
    placebo
    Primary Outcome Measure Information:
    Title
    Severity of self-reported bloating
    Description
    Likert scale
    Time Frame
    Study end (6 weeks from baseline)
    Title
    Severity of self-reported gas
    Description
    Likert scale
    Time Frame
    Study end (6 weeks from baseline)
    Title
    Severity of self-reported indigestion
    Description
    Likert scale
    Time Frame
    Study end (6 weeks from baseline)
    Title
    Severity of self-reported abdominal pain
    Description
    Likert scale
    Time Frame
    Study end (6 weeks from baseline)
    Title
    Severity of self-reported defecation irregularity
    Description
    Likert scale
    Time Frame
    Study end (6 weeks from baseline)
    Secondary Outcome Measure Information:
    Title
    Frequency of self-reported bloating
    Description
    Likert scale
    Time Frame
    Study end (6 weeks from baseline)
    Title
    Frequency of self-reported gas
    Description
    Likert scale
    Time Frame
    Study end (6 weeks from baseline)
    Title
    Frequency of self-reported indigestion
    Description
    Likert scale
    Time Frame
    Study end (6 weeks from baseline)
    Title
    Frequency of self-reported abdominal pain
    Description
    Likert scale
    Time Frame
    Study end (6 weeks from baseline)
    Title
    Frequency of self-reported defecation irregularity
    Description
    Likert scale
    Time Frame
    Study end (6 weeks from baseline)
    Other Pre-specified Outcome Measures:
    Title
    Gastrointestinal Symptom Rating Scale
    Time Frame
    Study end (6 weeks from baseline)
    Title
    Gastrointestinal Quality of Life Index
    Time Frame
    Study end (6 weeks from baseline)
    Title
    Bristol Stool Scale
    Time Frame
    Study end (6 weeks from baseline)
    Title
    Rescue medication usage
    Time Frame
    Study end (6 weeks from baseline)
    Title
    Adequate relief
    Description
    "In the past 7 days, have you had adequate relief of your gastrointestinal discomfort?"
    Time Frame
    Study end (6 weeks from baseline)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Agree to continue with typical diet and exercise habits during study Agree to use contraception or abstinence throughout study period, unless postmenopausal or surgically sterile (females only) Able to understand and voluntarily consent to the study and understand its nature and purpose including potential risks and side effects Exclusion Criteria: 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. 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. Daily consumption of another probiotic supplement or new consumption of fermented dairy products (yogurt, kefir, etc.) Usage of systemic steroids during the past 2 months Usage of antipsychotic medications during the past 2 months Usage of prednisone, 6-mercaptopurine, adalimumab, etanercept, infliximab, leflunomide, golimumab, or mycophenolate mofetil during the past 2 months Uncontrolled anxiety or current medication for anxiety disorder Pregnant or breastfeeding females History of alcohol, drug, or medication abuse Known allergies to any substance in the study product Previous major gastrointestinal tract surgery (colon resection, gastric bypass, etc.) Participation in another clinical trial within 30 days of screening
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chris D'Adamo, PhD
    Organizational Affiliation
    University of Maryland, College Park
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms

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