Effects of a Probiotic Supplement on Gastrointestinal Symptoms and Microbiome Modulation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Microbiota
- Sponsor
- The Center for Applied Health Sciences, LLC
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Abdominal discomfort
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
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);
Outcomes
Primary Outcomes
Abdominal discomfort
Time Frame: Change from baseline to 6 weeks.
Abdominal discomfort as measured by a 10 cm visual analogue scale, where higher values represent greater discomfort.
Gastrointestinal Symptom Rating Scale (GSRS)
Time Frame: Change from baseline to 6 weeks.
Gastrointestinal problems as measured by the GSRS questionnaire, where higher values represent increased severity of gastrointestinal problems.
Flatulence (gas)
Time Frame: Change from baseline to 6 weeks.
Flatulence (gas) as measured by a 10 cm visual analogue scale, where higher values represent greater flatulence.
Gastro-intestinal bloating
Time Frame: Change from baseline to 6 weeks.
Gastro-intestinal bloating as measured by a 10 cm visual analogue scale, where higher values represent greater bloating.
Secondary Outcomes
- Stool consistency(Change from baseline to 6 weeks.)
- Stool regularity(Change from baseline to 6 weeks.)
- Constipation(Change from baseline to 6 weeks.)