Overweight (BMI > 25)Early Phase 1NCT06912100

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

A Early Phase 1 study testing Probiotic in people with Overweight (BMI > 25) and Obese, Otherwise Healthy Volunteers, run by University of Connecticut at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Overweight (BMI > 25), Obese, Otherwise Healthy Volunteers
What is being tested?: Probiotic
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2025to Dec 2027
Phase: Early Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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
Weight changes > 10% over the last 4 weeks
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.
Dairy allergy
Currently pregnant or breast-feeding

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Connecticut, Department of Nutritional Sciences
Storrs, Connecticut, 06269

Other trials in United States

About this study

Official title: A Pilot Study of the Probiotic 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 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.

Conditions: Overweight (BMI > 25), Obese, Otherwise Healthy Volunteers
Being tested: Placebo, Probiotic
Keywords: obesity, probiotics, gut health
Medical subject headings: Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06912100
Study group	Role	What they receive
Placebo phase	Placebo comparator	Participants consume capsules containing only an inactive placebo (maltodextrin and magnesium stearate). Receives: Dietary Supplement: Placebo
Probiotic phase	Experimental	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). Receives: Dietary Supplement: Probiotic

What is being measured

The primary outcome is the main question the study is designed to answer.

Fecal butyrate
Determine the effects of the probiotic on the short-chain fatty acid, butyrate (mmol/L), a marker of gut health in stool
Measured: From baseline to the end of each 6-week intervention phase

Secondary outcomes (2)

Serum inflammation marker
Determine the effects of the probiotic on a marker of inflammation, high-sensitivity C-reactive protein (hsCRP) (mg/L), in the bloodstream
Measured: From baseline to the end of each 6-week intervention phase
Body fat composition
Determine the effects of the probiotic on body fat composition by bioelectric impedance analysis (% of body weight).
Measured: From baseline to end of each 6-week intervention phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 2025Dec 2027

First posted4 Apr 2025
Study start1 Jul 2025
Primary completion31 Dec 2026 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Overweight (BMI > 25)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 12 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06912100
Sponsor's protocol ID: B2025-0034
Status last verified: Aug 2026
First submitted: 24 Mar 2025
Last updated: 13 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Only IPD used in the results publication

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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