A Probiotic Blend Reduces Gastrointestinal Symptoms and Positively Impacts Microbiota Modulation in a Randomized Study

Study Overview
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Brief Summary
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This randomized, placebo-controlled, double-blind study will determine the effect of daily supplementation with a probiotic blend in 60 apparently healthy men and women recruited at a single investigational center in Northeast Ohio (i.e., The Center for Applied Health Sciences). Subjects will attend three study visits. During Visit 1, subjects will be screened for participation [i.e., medical history, routine blood work, background baseline diet]. During Visits 2 and 3 subjects will complete questionnaires that assess their gastrointestinal health (e.g., abdominal discomfort/bloating, constipation, regularity, stool consistency). Visits 2 and 3 will correspond to before (week 0) and after six weeks of supplementation, respectively, with the probiotic dietary supplement or placebo.

Official Title
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Effects of a Probiotic Supplement on Gastrointestinal Symptoms and Microbiome Modulation

Conditions
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Microbiota, Constipation, Candida

Intervention / Treatment
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* Dietary Supplement: 575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all participants were required to be between 30-60yr score ≥12 on the GSRS have a body mass ≥120 pounds (54.5kg) body mass index (BMI) between 20.0-34.99kg/m2 normotensive (<140/<90mmHg) normal resting heart rate (<90bpm) Exclusion Criteria: Female participants who were pregnant or nursing history of unstable or new-onset cardiovascular or cardiorespiratory disease; stroke, diabetes, or other endocrine disorder; use of any nutritional supplement known to alter the gut microbiota/microflora; use of probiotic supplements or prebiotic supplements in the previous 4 weeks and for the duration of the study; use of any antibiotics, antifungals, antivirals, or antiparasitic within 8 weeks of the start of the study or throughout the study; any changes in diet within 4 weeks of study start date or throughout study duration; if the participant was unwilling to abstain from gut altering supplements for the study; malignancy in the previous 5yr except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin); prior gastrointestinal bypass surgery (i.e., Lapband); any known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism [e.g. short bowel syndrome, diarrheal illnesses, history of colon resection, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU)]; any chronic inflammatory condition/disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.); known sensitivity to any ingredient in the test formulations as listed in the certificates of analysis. currently participating in another research study with an investigational product or had participated in another research study in the past 30 days any other diseases/conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Consists of 575 mg rice oligodextrin | Dietary Supplement: 575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase<br>* A multi-strain probiotic blend<br>|
| Active Comparator: Active<br>Consists of 575mg [30 billion colony forming units probiotic blend of Bifidobacterium breve 19bx, Lactobacillus acidophilus 16axg, Lacticaseibacillus rhamnosus 18fx, Saccharomyces boulardii 16mxg, and alpha amylase | Dietary Supplement: 575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase<br>* A multi-strain probiotic blend<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flatulence (gas) | Flatulence (gas) as measured by a 10 cm visual analogue scale, where higher values represent greater flatulence. | Change from baseline to 6 weeks. | 
| Gastro-intestinal bloating | Gastro-intestinal bloating as measured by a 10 cm visual analogue scale, where higher values represent greater bloating. | Change from baseline to 6 weeks. | 
| Abdominal discomfort | Abdominal discomfort as measured by a 10 cm visual analogue scale, where higher values represent greater discomfort. | Change from baseline to 6 weeks. | 
| Gastrointestinal Symptom Rating Scale (GSRS) | Gastrointestinal problems as measured by the GSRS questionnaire, where higher values represent increased severity of gastrointestinal problems. | Change from baseline to 6 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool consistency | Stool consistency as measured by a 10 cm visual analogue scale, where higher values represent harder stools. | Change from baseline to 6 weeks. | 
| Stool regularity | Stool regularity as measured by a 10 cm visual analogue scale, where higher values represent more regular stools. | Change from baseline to 6 weeks. | 
| Constipation | Constipation as measured by a 10 cm visual analogue scale, where higher values represent more greater constipation. | Change from baseline to 6 weeks. |