A Probiotic Blend Reduces Gastrointestinal Symptoms and Positively Impacts Microbiota Modulation in a Randomized Study
Microbiota, Constipation, Candida
About this trial
This is an interventional basic science trial for Microbiota
Eligibility Criteria
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.
Sites / Locations
- The Center for Applied Health Sciences
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo
Active
Consists of 575 mg rice oligodextrin
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