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Completed

NCT Number: NCT02277431

Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms

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.

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Key information

Conditions

Gastrointestinal Symptoms Abdominal Pain Bloating Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Defecation Irregularity Dyspepsia Gas Genetic Diseases, Inborn Indigestion Lysosomal Storage Diseases Metabolic Diseases Metabolism, Inborn Errors Mucinoses Mucopolysaccharidoses Mucopolysaccharidosis IV Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic dietary supplement (Trenev Trio®)

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)

Placebo

Dietary Supplement

Primary outcomes

  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 outcomes

  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 outcomes

  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?"

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 29, 2014
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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