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NCT06912100 · ClinicalTrials.gov registry record · Early Phase 1
L. Acidophilus (Strain TW01) on Gut Health, Body Composition, and Inflammation
A Early Phase 1 study of Overweight (BMI > 25) and Obese, Otherwise Healthy Volunteers, sponsored by University of Connecticut.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT06912100: Recruiting Early Phase 1 study of Overweight (BMI > 25) and Obese, Otherwise Healthy Volunteers, sponsored by University of Connecticut.
NCT06912100 is a Early Phase 1 study of Overweight (BMI > 25) and Obese, Otherwise Healthy Volunteers that is actively recruiting participants, run by University of Connecticut. The registered enrollment target is 12 participants, below the 59-participant average among 3 other Overweight (BMI > 25) trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06912100, a Early Phase 1 study of Overweight (BMI > 25) and Obese, Otherwise Healthy Volunteers, is actively recruiting participants, sponsored by University of Connecticut.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Determine the effects of the probiotic on the short-chain fatty acid, butyrate (mmol/L), a marker of gut health in stool
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Probiotic
Study Locations (1)
Connecticut
- University of Connecticut, Department of Nutritional Sciences - Storrs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-07-01 |
| Est. Completion | 2027-12 |
| Phase | Early Phase 1 |
What NCT06912100 shows while recruiting
NCT06912100 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 59-participant average among 3 other Overweight (BMI > 25) trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Overweight (BMI > 25) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06912100 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT06912100 about?
NCT06912100 is a clinical study titled "L. Acidophilus (Strain TW01) on Gut Health, Body Composition, and Inflammation". 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 ...
What is the current status of trial NCT06912100?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2025-07-01. Estimated completion is 2027-12.
What conditions does trial NCT06912100 study?
This clinical trial studies the following conditions: Overweight (BMI > 25), Obese, Otherwise Healthy Volunteers.
What interventions are being tested in trial NCT06912100?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Probiotic (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06912100?
This trial is sponsored by University of Connecticut, which has 107 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06912100 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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