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Search / Trial NCT05614726

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

Launched by THE CENTER FOR APPLIED HEALTH SCIENCES, LLC · Nov 11, 2022

Trial Information

Current as of June 17, 2025

Completed

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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.

About The Center For Applied Health Sciences, Llc

The Center for Applied Health Sciences, LLC, is a leading clinical research organization dedicated to advancing healthcare through innovative research methodologies and rigorous clinical trial management. With a commitment to enhancing patient outcomes, the Center specializes in providing comprehensive services that support the development of new therapeutics and medical interventions. Their team of experienced professionals collaborates with pharmaceutical and biotechnology companies to ensure the highest standards of safety, efficacy, and regulatory compliance throughout the research process. By leveraging cutting-edge technology and a patient-centric approach, the Center for Applied Health Sciences strives to contribute meaningfully to the evolution of medical science and improve the lives of patients globally.

Locations

Canfield, Ohio, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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