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A Probiotic Blend Reduces Gastrointestinal Symptoms and Positively Impacts Microbiota Modulation in a Randomized Study

Primary Purpose

Microbiota, Constipation, Candida

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase
Sponsored by
The Center for Applied Health Sciences, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Microbiota

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Center for Applied Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Active

Arm Description

Consists of 575 mg rice oligodextrin

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

Outcomes

Primary Outcome Measures

Flatulence (gas)
Flatulence (gas) as measured by a 10 cm visual analogue scale, where higher values represent greater flatulence.
Gastro-intestinal bloating
Gastro-intestinal bloating as measured by a 10 cm visual analogue scale, where higher values represent greater bloating.
Abdominal discomfort
Abdominal discomfort as measured by a 10 cm visual analogue scale, where higher values represent greater discomfort.
Gastrointestinal Symptom Rating Scale (GSRS)
Gastrointestinal problems as measured by the GSRS questionnaire, where higher values represent increased severity of gastrointestinal problems.

Secondary Outcome Measures

Stool consistency
Stool consistency as measured by a 10 cm visual analogue scale, where higher values represent harder stools.
Stool regularity
Stool regularity as measured by a 10 cm visual analogue scale, where higher values represent more regular stools.
Constipation
Constipation as measured by a 10 cm visual analogue scale, where higher values represent more greater constipation.

Full Information

First Posted
November 5, 2022
Last Updated
November 11, 2022
Sponsor
The Center for Applied Health Sciences, LLC
Collaborators
Biohm Health, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05614726
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
March 17, 2022 (Actual)
Study Completion Date
March 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Center for Applied Health Sciences, LLC
Collaborators
Biohm Health, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbiota, Constipation, Candida

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Consists of 575 mg rice oligodextrin
Arm Title
Active
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase
Intervention Description
A multi-strain probiotic blend
Primary Outcome Measure Information:
Title
Flatulence (gas)
Description
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.
Title
Gastro-intestinal bloating
Description
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.
Title
Abdominal discomfort
Description
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.
Title
Gastrointestinal Symptom Rating Scale (GSRS)
Description
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.
Secondary Outcome Measure Information:
Title
Stool consistency
Description
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.
Title
Stool regularity
Description
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.
Title
Constipation
Description
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.
Other Pre-specified Outcome Measures:
Title
Short Form Health Survey (SF-36)
Description
Health status as measured with the SF-36 questionnaire, where scores range from 0 to 100, and higher values represent better health status.
Time Frame
Change from baseline to 6 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
The Center for Applied Health Sciences
City
Canfield
State/Province
Ohio
ZIP/Postal Code
44406
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Probiotic Blend Reduces Gastrointestinal Symptoms and Positively Impacts Microbiota Modulation in a Randomized Study

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