Clinical trial NCT02277431: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Gastrointestinal Symptoms
Bloating
Gas
Indigestion
Abdominal Pain
Defecation Irregularity
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2014-10-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Severity of self-reported bloating
timeFrame: Study end (6 weeks from baseline)
measure: Severity of self-reported gas
timeFrame: Study end (6 weeks from baseline)
measure: Severity of self-reported indigestion
timeFrame: Study end (6 weeks from baseline)
measure: Severity of self-reported abdominal pain
timeFrame: Study end (6 weeks from baseline)
measure: Severity of self-reported defecation irregularity
timeFrame: Study end (6 weeks from baseline)
Secondary outcomes:
measure: Frequency of self-reported bloating
timeFrame: Study end (6 weeks from baseline)
measure: Frequency of self-reported gas
timeFrame: Study end (6 weeks from baseline)
measure: Frequency of self-reported indigestion
timeFrame: Study end (6 weeks from baseline)
measure: Frequency of self-reported abdominal pain
timeFrame: Study end (6 weeks from baseline)
measure: Frequency of self-reported defecation irregularity
timeFrame: Study end (6 weeks from baseline)
Other outcomes:
measure: Gastrointestinal Symptom Rating Scale
timeFrame: Study end (6 weeks from baseline)
measure: Gastrointestinal Quality of Life Index
timeFrame: Study end (6 weeks from baseline)
measure: Bristol Stool Scale
timeFrame: Study end (6 weeks from baseline)
measure: Rescue medication usage
timeFrame: Study end (6 weeks from baseline)
measure: Adequate relief
timeFrame: Study end (6 weeks from baseline)
Locations:
Study officials:
affiliation: University of Maryland, College Park
name: Chris D'Adamo, PhD
role: PRINCIPAL_INVESTIGATOR
References: