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

Not Applicable

Completed

• Conditions: Constipation; Candida; Microbiota

• 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

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