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

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.

Study Overview

• Status: Completed
• Conditions: Constipation; Microbiota; Candida
• Intervention / Treatment: Dietary supplement: 575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Canfield, Ohio, United States, 44406
      • The Center for Applied Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Consists of 575 mg rice oligodextrin	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
Active Comparator: Active; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flatulence (gas)	Flatulence (gas) as measured by a 10 cm visual analogue scale, where higher values represent greater flatulence.	Change from baseline to 6 weeks.
Gastro-intestinal bloating	Gastro-intestinal bloating as measured by a 10 cm visual analogue scale, where higher values represent greater bloating.	Change from baseline to 6 weeks.
Abdominal discomfort	Abdominal discomfort as measured by a 10 cm visual analogue scale, where higher values represent greater discomfort.	Change from baseline to 6 weeks.
Gastrointestinal Symptom Rating Scale (GSRS)	Gastrointestinal problems as measured by the GSRS questionnaire, where higher values represent increased severity of gastrointestinal problems.	Change from baseline to 6 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool consistency	Stool consistency as measured by a 10 cm visual analogue scale, where higher values represent harder stools.	Change from baseline to 6 weeks.
Stool regularity	Stool regularity as measured by a 10 cm visual analogue scale, where higher values represent more regular stools.	Change from baseline to 6 weeks.
Constipation	Constipation as measured by a 10 cm visual analogue scale, where higher values represent more greater constipation.	Change from baseline to 6 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form Health Survey (SF-36)	Health status as measured with the SF-36 questionnaire, where scores range from 0 to 100, and higher values represent better health status.	Change from baseline to 6 weeks.

Collaborators and Investigators

• Sponsor: The Center for Applied Health Sciences, LLC
• Collaborators: Biohm Health, LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2021
• Primary Completion (Actual): March 17, 2022
• Study Completion (Actual): March 17, 2022

Study Registration Dates

• First Submitted: November 5, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 21-CAHS-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No