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

Not Applicable

Completed

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

• Registration Number: NCT05614726
• Lead Sponsor: The Center for Applied Health Sciences, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-18
• Primary Completion: 2022-03-17
• Study Completion: 2022-03-17
• Status Verified: 2022-11
• Study First Submitted: 2022-11-05
• Study First Submitted QC: 2022-11-11
• Last Update Submitted: 2022-11-11
• Study First Posted: 2022-11-14
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase	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
Placebo	575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase	Consists of 575 mg rice oligodextrin

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Center for Applied Health Sciences; 🇺🇸 Canfield, Ohio, United States