Trenev Trio/Healthy Trinity for Symptoms of Diarrhea-predominant Irritable Bowel Syndrome (IBS) and Functional Dyspepsia

Study Overview
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Brief Summary
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Primary Objective: • To confirm the efficacy of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in the improvement of symptoms in adult patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and functional dyspepsia Secondary Objective: • To confirm the safety of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in adult patients with IBS-D and functional dyspepsia

Official Title
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A Double-blind, Randomized, Placebo-controlled, Dual-center Study on the Effect of Healthy Trinity (Retail Label)/Trenev Trio (Professional Label) on Symptoms of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) and Functional Dyspepsia

Conditions
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IBS-D and Functional Dyspepsia

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 75 years Diagnosed with IBS-D including: a) weekly average of worst abdominal pain in the last 24 hours of ≥3 on a 0-10 scale, and b) weekly average of Bristol Stool form of ≥6 on a 1-7 scale Diagnosed with functional dyspepsia defined as presence of at least one of the following symptoms: bothersome postprandial fullness, early satiation, epigastric pain, or epigastric burning AND no evidence of structural disease that is likely to explain the symptoms History of IBS-D and dyspepsia symptoms for at least 12 weeks Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only) Able to understand the nature and purpose of the study including potential risks and side effects Willing to consent to study participation and to comply with study requirements Successful completion of 2-week placebo-only run-in period, defined as ≥90% product compliance and completion of required questionnaires Exclusion Criteria: Major gastrointestinal complication, e.g. Crohn's disease or ulcer Prior abdominal surgery with the exception of hernia repair and appendectomy Subjects over 60 years who have not had a sigmoidoscopy or colonoscopy in the past 10 years Clinically significant systemic disease Life expectancy < 6 months Pregnant female or breastfeeding Lactose intolerance Immunodeficient subjects Anti-psychotic medication within the prior 3 months or major psychiatric disorder within the past 2 years Systemic steroids within the prior month Current treatment with nasogastric tube, ostomy, or parenteral nutrition Use of proton pump inhibitors Eating disorder Recent (< 2 weeks) antibiotic administration History of alcohol, drug, or medication abuse Daily consumption of probiotics, fermented milk, and/or yogurt Known allergies to any substance in the study product Participation in another study with any investigational product within 3 months of screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br> | Dietary Supplement: Probiotic<br>* 2 capsules, 3x/day capsules of Healthy Trinity (retail label)/Trenev Trio (professional label), for a total daily dose of: Lactobacillus acidophilus NAS, 30 billion CFU Bifidobacterium bifidum Malyoth, 120 billion CFU Lactobacillus delbrueckii subspecies bulgaricus LB-51, 30 billion CFU<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* 2 capsules, 3x/day placebo capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal pain severity |  | 8 weeks | 
| Stool consistency (Bristol Stool Chart) |  | 8 weeks | 
| Dyspepsia Symptom Severity Index (DSSI) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with 1 or more adverse events |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS, Diarrhea, Dyspepsia