Clinical trial NCT05614726: A Probiotic Blend Reduces Gastrointestinal Symptoms and Positively Impacts Microbiota Modulation in a Randomized Study
Official title: Effects of a Probiotic Supplement on Gastrointestinal Symptoms and Microbiome Modulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbiota
Constipation
Candida
Lead sponsor: The Center for Applied Health Sciences, LLC
Sponsor class: INDUSTRY
Collaborators: name: Biohm Health, LLC
First posted: 2022-11-14
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Flatulence (gas)
timeFrame: Change from baseline to 6 weeks.
measure: Gastro-intestinal bloating
timeFrame: Change from baseline to 6 weeks.
measure: Abdominal discomfort
timeFrame: Change from baseline to 6 weeks.
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: Change from baseline to 6 weeks.
Secondary outcomes:
measure: Stool consistency
timeFrame: Change from baseline to 6 weeks.
measure: Stool regularity
timeFrame: Change from baseline to 6 weeks.
measure: Constipation
timeFrame: Change from baseline to 6 weeks.
Other outcomes:
measure: Short Form Health Survey (SF-36)
timeFrame: Change from baseline to 6 weeks.
Locations:
city: Canfield
country: United States
facility: The Center for Applied Health Sciences
state: Ohio
Study officials:
References: