The Center for Applied Health Sciences
Canfield, Ohio, 44406, United States
NCT Number: NCT05614726
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.
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Notify Me30 year–60 year
All sexes
Interventional
Not applicable
Canfield, Ohio, 44406, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A multi-strain probiotic blend
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.
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.
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.
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.
Time frame: Change from baseline to 6 weeks.
Stool consistency as measured by a 10 cm visual analogue scale, where higher values represent harder stools.
Time frame: Change from baseline to 6 weeks.
Stool regularity as measured by a 10 cm visual analogue scale, where higher values represent more regular stools.
Time frame: Change from baseline to 6 weeks.
Constipation as measured by a 10 cm visual analogue scale, where higher values represent more greater constipation.
Time frame: Change from baseline to 6 weeks.
Health status as measured with the SF-36 questionnaire, where scores range from 0 to 100, and higher values represent better health status.
The Center for Applied Health Sciences, LLC
Industry
Effects of a Probiotic Supplement on Gastrointestinal Symptoms and Microbiome Modulation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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