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COMPLETEDPHASE2/PHASE3

Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms

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

NCT02277431•University of Maryland, Baltimore

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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
+2 more criteria

Key Dates

Start Date

December 1, 2014

Primary Completion Date

September 1, 2015

Completion Date

October 1, 2015

Last Updated

September 14, 2021

Enrollment

ACTUAL participants

Conditions

Gastrointestinal SymptomsBloatingGasIndigestionAbdominal PainDefecation Irregularity

Interventions

Probiotic dietary supplement (Trenev Trio®)

DIETARY_SUPPLEMENT

placebo

DIETARY_SUPPLEMENT

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

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RECRUITINGPHASE1/PHASE2

Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

NCT06290258

Autism Spectrum DisorderGastrointestinal Diseases+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 14, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Eosinophilic Gastrointestinal Disorders Registry

Pain Assessment Following Placement of a Percutaneous Radiologic Gastrostomy and Predictive Factors