RECRUITING

L. Acidophilus (Strain TW01) on Gut Health, Body Composition, and Inflammation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a pilot research study to investigate the effects of a probiotic supplement (L. acidophilus, strain TW01) on substances found in the stool and bloodstream, gut bacteria composition, body composition, as well as any relationship of these substances with markers of inflammation. Lactobacillus acidophilus is commonly found in a variety of fermented foods, including yogurt, cheese, and kefir, due to its ability to produce lactic acid and other substances. This bacterium is generally well-tolerated in healthy individuals and has a longstanding history of safe use. The investigators are doing this pilot study to see if a particular probiotic, called L. acidophilus (strain TW01) and isolated from fermented coffee grounds, can make a positive difference in human gut and overall health. Specifically, the investigators want to look at how this probiotic affects certain substances in human stool and blood, the makeup of the bacteria in the gut, and aspects of body composition. The investigators are also interested in whether these changes relate to markers of inflammation, which can tell us more about their impact on overall health. This probiotic strain has been shown in other studies to be safe and well tolerated, and the investigators hope our research will help us better understand how it works and whether it might support health in humans.

Official Title

A Pilot Study of the Probiotic L. Acidophilus (Strain TW01) on Gut Health, Body Composition, and Inflammation

Quick Facts

Study Start:2025-07-01
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06912100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18-60 years
  2. 2. Body mass index (BMI) between 28 kg/m2 and 40 kg/m2
  3. 3. Waist circumference ≥ 88 cm or 35 inches for women, ≥ 102 cm or 40 inches for men
  4. 4. Willing to consume experimental capsules daily
  5. 5. Willing to prepare and consume the delivered meal kits
  6. 6. Do not fit any exclusion criteria
  1. 1. Self-reported history of immunodeficiency, major gastrointestinal surgery, renal or liver disease, diabetes, heart disease, stroke, peripheral artery/vascular disease, cancer, eating disorders, gut-associated pathologies, autoimmune diseases, pacemaker, thyroid disease, gallbladder disease, chronic inflammatory diseases, scleroderma, blood clotting disorders, intravenous drug use
  2. 2. Weight changes \> 10% over the last 4 weeks
  3. 3. Oral antibiotics and/or probiotics use up to 1 month prior to study and during study
  4. 4. Currently taking GLP-1 analogues (e.g., Ozempic), anti-inflammatory medications (e.g., corticosteroids), daily use of nonsteroidal anti-inflammatory drugs (NSAIDs) (occasional use is permitted), medications which primarily affect blood clotting (e.g., warfarin), or any medications that suppress the immune system.
  5. 5. Dairy allergy
  6. 6. Currently pregnant or breast-feeding

Contacts and Locations

Study Contact

Christopher Blesso, Ph.D.
CONTACT
860-486-9049
christopher.blesso@uconn.edu

Study Locations (Sites)

University of Connecticut, Department of Nutritional Sciences
Storrs, Connecticut, 06269
United States

Collaborators and Investigators

Sponsor: University of Connecticut

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-01
Study Completion Date2027-12

Study Record Updates

Study Start Date2025-07-01
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • obesity
  • probiotics
  • gut health

Additional Relevant MeSH Terms

  • Overweight (BMI > 25)
  • Obese, Otherwise Healthy Volunteers