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Probiotic / Obese, Otherwise Healthy Volunteers / Overweight (BMI > 25) · Phase EARLY_PHASE1 Trial
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered early-phase pilot study of L. acidophilus strain TW01 in overweight and obese volunteers, planned to measure fecal butyrate and related markers over 6-week intervention cycles. No results are yet reported in this registry record, and the small pilot sample size precludes any claim of efficacy or safety.
Early Phase 1, Interventional, Randomized, Crossover, Single masking, Prevention purpose. Overweight (BMI > 25), Obese, Otherwise Healthy Volunteers; age from 18 Years; to 60 Years; accepts healthy volunteers. Intervention: Probiotic phase. Compared with: Placebo phase — Placebo Comparator. n = 12. 1 site: United States.
This is a registered early-phase pilot study of L. acidophilus strain TW01 in overweight and obese volunteers, planned to measure fecal butyrate and related markers over 6-week intervention cycles. No results are yet reported in this registry record, and the small pilot sample size precludes any claim of efficacy or safety.
Very small pilot sample (n=12) cannot support definitive efficacy or safety claims
This study is at planning or early recruitment stage and carries no clinical implications until results are published. Clinicians should not interpret this registry entry as evidence of benefit or safety.
This is an early-phase pilot study registration with no results posted; it describes planned enrollment and methods only, insufficient to assess efficacy or safety outcomes.
As stated by the source record.
Quoted from the source exactly as published.
This study is at planning or early recruitment stage and carries no clinical implications until results are published. Clinicians should not interpret this registry entry as evidence of benefit or safety.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06912100). This is a study registration, not published results. Lead sponsor: University of Connecticut. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: EARLY_PHASE1. Study type: INTERVENTIONAL. Enrollment: 12 participants (ESTIMATED). Conditions: Overweight (BMI > 25), Obese, Otherwise Healthy Volunteers. Interventions: DIETARY_SUPPLEMENT: Placebo; DIETARY_SUPPLEMENT: Probiotic. Primary outcome measures: Fecal butyrate , From baseline to the end of each 6-week intervention phase. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.