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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Pain; Bloating; Indigestion; Gastrointestinal Symptoms; Gas; Defecation Irregularity
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: Probiotic dietary supplement (Trenev Trio®)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Probiotic 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)	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)
PLACEBO_COMPARATOR: 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.	Dietary supplement: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of self-reported bloating	Likert scale	Study end (6 weeks from baseline)
Severity of self-reported gas	Likert scale	Study end (6 weeks from baseline)
Severity of self-reported indigestion	Likert scale	Study end (6 weeks from baseline)
Severity of self-reported abdominal pain	Likert scale	Study end (6 weeks from baseline)
Severity of self-reported defecation irregularity	Likert scale	Study end (6 weeks from baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of self-reported bloating	Likert scale	Study end (6 weeks from baseline)
Frequency of self-reported gas	Likert scale	Study end (6 weeks from baseline)
Frequency of self-reported indigestion	Likert scale	Study end (6 weeks from baseline)
Frequency of self-reported abdominal pain	Likert scale	Study end (6 weeks from baseline)
Frequency of self-reported defecation irregularity	Likert scale	Study end (6 weeks from baseline)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Symptom Rating Scale		Study end (6 weeks from baseline)
Gastrointestinal Quality of Life Index		Study end (6 weeks from baseline)
Bristol Stool Scale		Study end (6 weeks from baseline)
Rescue medication usage		Study end (6 weeks from baseline)
Adequate relief	"In the past 7 days, have you had adequate relief of your gastrointestinal discomfort?"	Study end (6 weeks from baseline)

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: October 24, 2014
• First Submitted That Met QC Criteria: October 28, 2014
• First Posted (ESTIMATE): October 29, 2014

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Dyspepsia; Abdominal Pain
• Other Study ID Numbers: 00007145