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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

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Symptoms Bloating Gas Indigestion Abdominal Pain Defecation Irregularity Dietary Supplement: Probiotic dietary supplement (Trenev Trio®) Dietary Supplement: placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 Start Date : December 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
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)

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.
Dietary Supplement: placebo



Primary Outcome Measures :
  1. Severity of self-reported bloating [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale

  2. Severity of self-reported gas [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale

  3. Severity of self-reported indigestion [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale

  4. Severity of self-reported abdominal pain [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale

  5. Severity of self-reported defecation irregularity [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale


Secondary Outcome Measures :
  1. Frequency of self-reported bloating [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale

  2. Frequency of self-reported gas [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale

  3. Frequency of self-reported indigestion [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale

  4. Frequency of self-reported abdominal pain [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale

  5. Frequency of self-reported defecation irregularity [ Time Frame: Study end (6 weeks from baseline) ]
    Likert scale


Other Outcome Measures:
  1. Gastrointestinal Symptom Rating Scale [ Time Frame: Study end (6 weeks from baseline) ]
  2. Gastrointestinal Quality of Life Index [ Time Frame: Study end (6 weeks from baseline) ]
  3. Bristol Stool Scale [ Time Frame: Study end (6 weeks from baseline) ]
  4. Rescue medication usage [ Time Frame: Study end (6 weeks from baseline) ]
  5. Adequate relief [ Time Frame: Study end (6 weeks from baseline) ]
    "In the past 7 days, have you had adequate relief of your gastrointestinal discomfort?"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277431


Sponsors and Collaborators
University of Maryland, College Park
Investigators
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Principal Investigator: Chris D'Adamo, PhD University of Maryland, College Park
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Responsible Party: Chris D'Adamo, Assistant Professor Department of Family and Community Medicine Department of Epidemiology and Public Health Director of Research Center for Integrative Medicine, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT02277431    
Other Study ID Numbers: 00007145
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Abdominal Pain
Dyspepsia
Pain
Neurologic Manifestations
Signs and Symptoms, Digestive