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

NCT05614726 | Completed

• 1 other identifier: 21-CAHS-102
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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 Outcomes (3)

• Stool consistency

  Change from baseline to 6 weeks.

• Stool regularity

  Change from baseline to 6 weeks.

• Constipation

  Change from baseline to 6 weeks.

Other Outcomes (1)

• Short Form Health Survey (SF-36)

  Change from baseline to 6 weeks.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Consists of 575 mg rice oligodextrin

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

Active

ACTIVE COMPARATOR

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

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

Interventions

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

A multi-strain probiotic blend

Active; Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Center for Applied Health Sciences, LLC: lead
• Biohm Health, LLC: collaborator

Study Sites (1)

The Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

Location

Related Publications (1)

• 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.

  PMID: 38350481 DERIVED

MeSH Terms

Conditions

Constipation; Torulopsis

Interventions

Lacteol; alpha-Amylases

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amylases; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2022
• First Posted: November 14, 2022
• Study Start: June 18, 2021
• Primary Completion: March 17, 2022
• Study Completion: March 17, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

US (1)