Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms

Abdominal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277431
• Other study ID #: 00007145
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 2014
• Est. completion date: October 2015

Study information

• Verified date: September 2021
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Bloating
• Defecation Irregularity
• Dyspepsia
• Gas
• Gastrointestinal Symptoms
• Indigestion

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gastrointestinal Symptom Rating Scale		Study end (6 weeks from baseline)
Other	Gastrointestinal Quality of Life Index		Study end (6 weeks from baseline)
Other	Bristol Stool Scale		Study end (6 weeks from baseline)
Other	Rescue medication usage		Study end (6 weeks from baseline)
Other	Adequate relief	"In the past 7 days, have you had adequate relief of your gastrointestinal discomfort?"	Study end (6 weeks from baseline)
Primary	Severity of self-reported bloating	Likert scale	Study end (6 weeks from baseline)
Primary	Severity of self-reported gas	Likert scale	Study end (6 weeks from baseline)
Primary	Severity of self-reported indigestion	Likert scale	Study end (6 weeks from baseline)
Primary	Severity of self-reported abdominal pain	Likert scale	Study end (6 weeks from baseline)
Primary	Severity of self-reported defecation irregularity	Likert scale	Study end (6 weeks from baseline)
Secondary	Frequency of self-reported bloating	Likert scale	Study end (6 weeks from baseline)
Secondary	Frequency of self-reported gas	Likert scale	Study end (6 weeks from baseline)
Secondary	Frequency of self-reported indigestion	Likert scale	Study end (6 weeks from baseline)
Secondary	Frequency of self-reported abdominal pain	Likert scale	Study end (6 weeks from baseline)
Secondary	Frequency of self-reported defecation irregularity	Likert scale	Study end (6 weeks from baseline)