Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms

NCT02277431 | Completed Phase 2

• 1 other identifier: 00007145
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Frequency of self-reported bloating

  Study end (6 weeks from baseline)

• Frequency of self-reported gas

  Study end (6 weeks from baseline)

• Frequency of self-reported indigestion

  Study end (6 weeks from baseline)

• Frequency of self-reported abdominal pain

  Study end (6 weeks from baseline)

• Frequency of self-reported defecation irregularity

  Study end (6 weeks from baseline)

Other Outcomes (5)

• 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)

Study Arms (2)

Probiotic dietary supplement

EXPERIMENTAL

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®)

Placebo

PLACEBO COMPARATOR

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

Interventions

Probiotic dietary supplement (Trenev Trio®) 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)

Probiotic dietary supplement

placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)
• Usage of systemic steroids during the past 2 months
• Usage of antipsychotic medications during the past 2 months
• Usage of prednisone, 6-mercaptopurine, adalimumab, etanercept, infliximab, leflunomide, golimumab, or mycophenolate mofetil during the past 2 months
• Uncontrolled anxiety or current medication for anxiety disorder
• Pregnant or breastfeeding females
• History of alcohol, drug, or medication abuse
• Known allergies to any substance in the study product
• Previous major gastrointestinal tract surgery (colon resection, gastric bypass, etc.)
• Participation in another clinical trial within 30 days of screening

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

MeSH Terms

Conditions

Mucopolysaccharidosis IV; Dyspepsia; Abdominal Pain

Condition Hierarchy (Ancestors)

Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Officials

• Chris D'Adamo, PhD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Family and Community Medicine Department of Epidemiology and Public Health Director of Research Center for Integrative Medicine

Study Record Dates

• First Submitted: October 24, 2014
• First Posted: October 29, 2014
• Study Start: December 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: September 14, 2021

Record last verified: 2021-09