Lactobacillus acidophilus (TW01) for gut health, body composition, and inflammation
A Pilot Study of the Probiotic L. Acidophilus (Strain TW01) on Gut Health, Body Composition, and Inflammation
This pilot will try a daily Lactobacillus acidophilus (TW01) probiotic versus placebo in adults with overweight or obesity to see if it changes gut bacteria, stool and blood markers, body composition, and inflammation.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Connecticut Academic / other |
| Locations | 1 site (Storrs, Connecticut) |
| Trial ID | NCT06912100 on ClinicalTrials.gov |
What this trial studies
This early-phase, randomized pilot compares a daily oral Lactobacillus acidophilus (TW01) supplement to a placebo in otherwise healthy adults with overweight or obesity. Participants (age 18–60, BMI 28–40 kg/m2, specified waist circumference) will take study capsules daily and consume provided meal kits while investigators collect stool and blood samples and measure body composition. Outcomes include changes in gut microbiome composition, stool- and blood-based metabolites, and markers of inflammation, along with safety and tolerability. The study is single-center at the University of Connecticut and designed to generate preliminary signals to guide larger trials.
Who should consider this trial
Good fit: Adults aged 18–60 with BMI 28–40 kg/m2 and waist circumference ≥88 cm (women) or ≥102 cm (men), willing to take daily capsules and consume delivered meal kits, and without major chronic diseases or recent antibiotic/probiotic use are ideal candidates.
Not a fit: People with major chronic illnesses (for example, diabetes, significant heart, liver, or kidney disease), recent large weight changes, current GLP‑1 analogue use, recent antibiotic or probiotic use, or other listed exclusion criteria are unlikely to be eligible or receive benefit.
Why it matters
Potential benefit: If successful, the probiotic could offer a safe, diet-compatible way to shift gut bacteria and related inflammation markers and potentially support modest improvements in body composition for people with overweight or obesity.
How similar studies have performed: Some small studies of Lactobacillus and other probiotic strains have shown modest, strain-specific effects on gut microbiota and metabolic or inflammatory markers, but results are mixed and the TW01 strain is relatively untested in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-60 years 2. Body mass index (BMI) between 28 kg/m2 and 40 kg/m2 3. Waist circumference ≥ 88 cm or 35 inches for women, ≥ 102 cm or 40 inches for men 4. Willing to consume experimental capsules daily 5. Willing to prepare and consume the delivered meal kits 6. Do not fit any exclusion criteria Exclusion Criteria: 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. Weight changes \> 10% over the last 4 weeks 3. Oral antibiotics and/or probiotics use up to 1 month prior to study and during study 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. Dairy allergy 6. Currently pregnant or breast-feeding
Where this trial is running
Storrs, Connecticut
- University of Connecticut, Department of Nutritional Sciences — Storrs, Connecticut, United States (Recruiting)
Study contacts
- Study coordinator: Christopher Blesso, Ph.D.
- Email: christopher.blesso@uconn.edu
- Phone: 860-486-9049
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.