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RECRUITING
NCT06912100
EARLY_PHASE1

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

Sponsor: University of Connecticut

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2025-07-01

Completion Date

2027-12

Last Updated

2025-07-25

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Placebo

Participants consume capsules containing only an inactive placebo (maltodextrin and magnesium stearate).

DIETARY_SUPPLEMENT

Probiotic

Participants consume capsules containing L. acidophilus (TW01) at 4×10\^10 CFU/capsule (three capsules daily, totaling 1.2×10\^11 CFU/day) plus a commercial fiber source (Fibersol-2).

Locations (1)

University of Connecticut, Department of Nutritional Sciences

Storrs, Connecticut, United States