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

The Center for Applied Health Sciences, LLC52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Microbiota Constipation Candida

Interventions

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Flatulence (gas)

Flatulence (gas) as measured by a 10 cm visual analogue scale, where higher values represent greater flatulence.