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

Constipation Clinical Trial

Official title:

Effects of a Probiotic Supplement on Gastrointestinal Symptoms and Microbiome Modulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05614726
• Other study ID #: 21-CAHS-102
• Status: Completed
• Phase: N/A
• Start date: June 18, 2021
• Est. completion date: March 17, 2022

Study information

• Verified date: November 2022
• Source: The Center for Applied Health Sciences, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 17, 2022
• Est. primary completion date: March 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Candida
• Constipation
• Microbiota

Intervention

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

Locations

Country	Name	City	State
United States	The Center for Applied Health Sciences	Canfield	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Center for Applied Health Sciences, LLC	Biohm Health, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	Constipation	Constipation as measured by a 10 cm visual analogue scale, where higher values represent more greater constipation.	Change from baseline to 6 weeks.