Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms

NCT ID: NCT02277431

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-10-31

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.

Conditions

Gastrointestinal Symptoms; Bloating; Gas; Indigestion; Abdominal Pain; Defecation Irregularity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

Probiotic dietary supplement (Trenev Trio®)

Intervention Type: 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)

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

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)

Intervention Type: DIETARY_SUPPLEMENT

placebo

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Chris D'Adamo

Assistant Professor Department of Family and Community Medicine Department of Epidemiology and Public Health Director of Research Center for Integrative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chris D'Adamo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Other Identifiers

00007145

Identifier Type: -

Identifier Source: org_study_id