CompletedPhase 2/3

Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms

80 participantsStarted 2014-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.)

What they're measuring

Severity of self-reported bloating

Timeframe: Study end (6 weeks from baseline)

Severity of self-reported gas

Timeframe: Study end (6 weeks from baseline)

Severity of self-reported indigestion

Timeframe: Study end (6 weeks from baseline)

Severity of self-reported abdominal pain

Timeframe: Study end (6 weeks from baseline)

Severity of self-reported defecation irregularity

Timeframe: Study end (6 weeks from baseline)

Trial details

NCT IDNCT02277431

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-09

View on ClinicalTrials.gov More Gastrointestinal Symptoms trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.)

What they're measuring

Severity of self-reported bloating

Timeframe: Study end (6 weeks from baseline)

Severity of self-reported gas

Timeframe: Study end (6 weeks from baseline)

Severity of self-reported indigestion

Timeframe: Study end (6 weeks from baseline)

Severity of self-reported abdominal pain

Timeframe: Study end (6 weeks from baseline)

Severity of self-reported defecation irregularity

Timeframe: Study end (6 weeks from baseline)