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

NCT ID: NCT05614726

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-18
• Study Completion Date: 2022-03-17

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.

Conditions

Microbiota; Constipation; Candida

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Placebo

Consists of 575 mg rice oligodextrin

Group Type: PLACEBO_COMPARATOR

575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase

Intervention Type: DIETARY_SUPPLEMENT

A multi-strain probiotic blend

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

Group Type: ACTIVE_COMPARATOR

575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase

Intervention Type: DIETARY_SUPPLEMENT

A multi-strain probiotic blend

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biohm Health, LLC

UNKNOWN

Sponsor Role: collaborator

The Center for Applied Health Sciences, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Center for Applied Health Sciences

Canfield, Ohio, United States

Countries

United States

References

La Monica MB, Raub B, Lopez HL, Ziegenfuss TN. A probiotic amylase blend reduces gastrointestinal symptoms in a randomised clinical study. Benef Microbes. 2023 Oct 23;14(5):459-476. doi: 10.1163/18762891-20230043.

Reference Type: DERIVED

PMID: 38350481 (View on PubMed)

Other Identifiers

21-CAHS-102

Identifier Type: -

Identifier Source: org_study_id