Probiotic for Obesity

Overseen By Christopher Blesso, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Connecticut

Must not be taking: GLP-1 analogues, Anti-inflammatories, NSAIDs, others

Disqualifiers: Immunodeficiency, Diabetes, Heart disease, others

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether the probiotic L. acidophilus (strain TW01) can positively affect gut health and inflammation markers in people with obesity. Participants will take either the probiotic or a placebo to assess its impact on substances in their stool and blood, gut bacteria, and body composition. The study seeks adults with a BMI between 28 and 40 and a large waistline, who are willing to take capsules daily and adhere to a meal plan. As an Early Phase 1 trial, this research aims to understand how this new probiotic works in people, offering participants the opportunity to be among the first to receive this treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. The trial excludes participants who are currently taking GLP-1 analogues, anti-inflammatory medications, daily NSAIDs, medications affecting blood clotting, or those that suppress the immune system.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the probiotic L. acidophilus (strain TW01) is generally safe and well-tolerated in people. This type of bacteria, often found in foods like yogurt, has been used safely for a long time. Other studies have found that this probiotic does not cause major side effects in healthy individuals. Probiotics, including L. acidophilus, are usually considered safe for people. Although this study is still in the early stages, current evidence supports the safety of this probiotic strain. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using L. acidophilus (Strain TW01) for obesity because it introduces a novel approach compared to traditional treatments like lifestyle changes, medications, and surgery. Unlike these options, which often focus on reducing calorie intake or altering the body's metabolism through drugs, this probiotic treatment works by potentially balancing gut bacteria, which may influence weight management. Additionally, the inclusion of a commercial fiber source, Fibersol-2, could enhance digestion and promote a feeling of fullness, offering a more natural and possibly safer alternative with fewer side effects. This innovative method could pave the way for new strategies in tackling obesity.

What evidence suggests that this probiotic might be an effective treatment for obesity?

Research has shown that the L. acidophilus strain TW01 probiotic can help mice on a high-fat diet lose weight and body fat. These studies also found that it reduces inflammation, which is important for addressing health problems related to obesity. The probiotic improves gut health and metabolism, potentially aiding in weight control. Although these results come from studies in mice, they suggest that this probiotic could address similar issues in humans. In this trial, participants will receive either the probiotic or a placebo at random. The main goal is to understand how the probiotic affects substances in the gut and body and its connection to inflammation. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with pneumonia or who are overweight, aiming to explore the effects of L. acidophilus (strain TW01) on gut health and body composition. Participants should be interested in how probiotics might influence their stool substances, blood markers, gut bacteria, and inflammation levels.

Inclusion Criteria

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

Exclusion Criteria

I have not taken antibiotics or probiotics within the last month.

Weight changes > 10% over the last 4 weeks

Dairy allergy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Placebo Phase

Participants consume capsules containing only an inactive placebo (maltodextrin and magnesium stearate)

6 weeks

Probiotic Phase

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)

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• L. Acidophilus (Strain TW01)

Trial Overview The study tests a probiotic supplement (L. acidophilus strain TW01) against a placebo to see if it improves gut health and reduces inflammation. It's a pilot study examining changes in stool and blood substances, gut bacteria diversity, body composition, and inflammatory markers.

How Is the Trial Designed?

Group I: Probiotic phase Experimental Treatment 1 Intervention

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).

Group II: Placebo phase Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Connecticut

Lead Sponsor

Trials

194

Recruited

162,000+

Published Research Related to This Trial

In a 12-week clinical trial involving 81 adults with obesity, the probiotic Lactobacillus plantarum K50 (LPK) significantly reduced total cholesterol and triglyceride levels compared to a placebo, indicating potential benefits for blood lipid profiles.

While LPK did not lead to significant changes in body weight or fat mass, it positively altered gut microbiota composition, which correlated with changes in visceral fat, suggesting a mechanism for its effects on lipid metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lactobacillus plantarum K50 on Lipids in Koreans With Obesity: A Randomized, Double-Blind Controlled Clinical Trial. Sohn, M., Na, GY., Chu, J., et al.[2022]

In a study involving 100 overweight and obese participants, the probiotic supplement MED-02 significantly reduced body fat mass by 1166.82 g and body weight by 2.06 kg over 12 weeks compared to a placebo.

The safety profile of MED-02 was confirmed as no serious adverse effects were reported, indicating it is a safe option for weight management in overweight and obese individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of MED-02 Containing Two Probiotic Strains, Limosilactobacillus fermentum MG4231 and MG4244, on Body Fat Reduction in Overweight or Obese Subjects: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study. Cho, YG., Yang, YJ., Yoon, YS., et al.[2022]

In a study involving 87 adults with obesity tendencies, the probiotic Lactobacillus gasseri SBT2055 (LG2055) significantly reduced abdominal visceral fat by an average of 4.6% and subcutaneous fat by 3.3% over 12 weeks, indicating its potential effectiveness in combating obesity.

Participants consuming LG2055 also experienced significant reductions in body weight (1.4%), BMI (1.5%), and waist circumference (1.8%), while the control group showed no significant changes, highlighting the probiotic's role in improving metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulation of abdominal adiposity by probiotics (Lactobacillus gasseri SBT2055) in adults with obese tendencies in a randomized controlled trial. Kadooka, Y., Sato, M., Imaizumi, K., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06912100

L. Acidophilus (Strain TW01) on Gut Health, Body ... A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may ...

2. withpower.com withpower.com/trial/probiotic-for-obesity-77fdb

Probiotic for Obesity · Recruiting Participants for Phase ... Research shows that L. Acidophilus can help reduce body weight, fat mass, and inflammation in mice on a high-fat diet by improving gut health and metabolism.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34896249/

Lactobacillus acidophilus ameliorates obesity in mice ... It is found that L. acidophilus reduces body weight, fat mass, inflammation and insulin resistance in mice fed with a high-fat diet (HFD).

4. mdpi.com mdpi.com/2304-8158/12/17/3278/review_report

Systematic Investigation of the Effect of Lactobacillus ... L. acidophilus TW01 have been tested for the resistance of acid and bile salt. This study is mainly to screen potential strains with in vitro methods. The ...

5. researchgate.net researchgate.net/publication/373615426_Systematic_Investigation_of_the_Effect_of_Lactobacillus_acidophilus_TW01_on_Potential_Prevention_of_Particulate_Matter_PM25-Induced_Damage_Using_a_Novel_In_Vitro_Platform

(PDF) Systematic Investigation of the Effect of Lactobacillus ... ... L. acidophilus TW01 is a promising probiotic strain for the potential ... probiotic and postbiotic reduced body weight loss by 47.1% and ...

6. trialx.com trialx.com/clinical-trials/listings/300674/l-acidophilus-strain-tw01-on-gut-health-body-composition-and-inflammation/

L. Acidophilus (Strain TW01) on Gut Health, Body ... This probiotic strain has been shown in other studies to be safe and well tolerated, and the investigators hope our research will help us ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11901689/

Lactobacillus acidophilus TW01 Mitigates PM2.5-Induced ... This study examines the protective effects of this strain on lung damage induced by particulate matter (PM) through the gut–lung axis in mouse models.

8. trial.medpath.com trial.medpath.com/clinical-trial/477ba4b079196582/probiotic-l-acidophilus-gut-health-inflammation

L. Acidophilus (Strain TW01) on Gut Health, Body ... - MedPath 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 ...