Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms

Phase 2

Completed

• Conditions: Indigestion; Defecation Irregularity; Abdominal Pain; Gastrointestinal Symptoms; Bloating; Gas
• Interventions: Dietary Supplement: placebo; Dietary Supplement: Probiotic dietary supplement (Trenev Trio®)

• Registration Number: NCT02277431
• Lead Sponsor: University of Maryland, Baltimore

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-24
• Study First Submitted QC: 2014-10-28
• Study First Posted: 2014-10-29
• Study Start: 2014-12
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-06
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Probiotic 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)

Primary Outcome Measures

Name	Time	Method
Severity of self-reported indigestion	Study end (6 weeks from baseline)	Likert scale
Severity of self-reported gas	Study end (6 weeks from baseline)	Likert scale
Severity of self-reported abdominal pain	Study end (6 weeks from baseline)	Likert scale
Severity of self-reported defecation irregularity	Study end (6 weeks from baseline)	Likert scale
Severity of self-reported bloating	Study end (6 weeks from baseline)	Likert scale

Secondary Outcome Measures

Name	Time	Method
Frequency of self-reported abdominal pain	Study end (6 weeks from baseline)	Likert scale
Frequency of self-reported bloating	Study end (6 weeks from baseline)	Likert scale
Frequency of self-reported defecation irregularity	Study end (6 weeks from baseline)	Likert scale
Frequency of self-reported gas	Study end (6 weeks from baseline)	Likert scale
Frequency of self-reported indigestion	Study end (6 weeks from baseline)	Likert scale