NCT06912100Active, not recruitingEarly phase 1
L. Acidophilus (Strain TW01) on Gut Health, Body Composition, and Inflammation
A Pilot Study of the Probiotic L. Acidophilus (Strain TW01) on Gut Health, Body Composition, and Inflammation
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 24 Mar 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Connecticut
- Diseases
- Obesity
- NCT number
- NCT06912100
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 12
- From 1 Jul 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Oral antibiotics and/or probiotics use up to 1 month prior to study and during study
- 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.
Other illness
- 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
- Dairy allergy
Other
- Weight changes \> 10% over the last 4 weeks
- Currently pregnant or breast-feeding
Who the study is looking for
- Age 18-60 years
- Body mass index (BMI) between 28 kg/m2 and 40 kg/m2
- Waist circumference ≥ 88 cm or 35 inches for women, ≥ 102 cm or 40 inches for men
- Willing to consume experimental capsules daily
- Willing to prepare and consume the delivered meal kits
- Do not fit any exclusion criteria
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Connecticut, Department of Nutritional Sciences Coordinator of this site? Confirm its status | Storrs | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.