Trials / Completed
CompletedNCT05614726
A Probiotic Blend Reduces Gastrointestinal Symptoms and Positively Impacts Microbiota Modulation in a Randomized Study
Effects of a Probiotic Supplement on Gastrointestinal Symptoms and Microbiome Modulation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- The Center for Applied Health Sciences, LLC · Industry
- Sex
- All
- Age
- 30 Years – 60 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | 575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase | A multi-strain probiotic blend |
Timeline
- Start date
- 2021-06-18
- Primary completion
- 2022-03-17
- Completion
- 2022-03-17
- First posted
- 2022-11-14
- Last updated
- 2022-11-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05614726. Inclusion in this directory is not an endorsement.