Probiotics for Obesity

Overseen By Allison Vaughan, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Hunger medications

Disqualifiers: Type 1 diabetes, Vascular disease, Neurological disease, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The current standard of care for obesity is the optimal management of comorbid conditions such as diabetes and hyperlipidemia, and counseling on diet, weight loss, or increased physical activity programs. However, lifestyle, diet, and behavioral interventions may provide between 7-10% reduction in initial weight and even fewer with long-term weight loss. In severely obese patients (BMI\>40 or BMI\>35 with comorbidities), bariatric surgery is also a potential treatment, but there is a high barrier for patients to undergo surgery for weight loss. These barriers include an aversion to major abdominal surgery, long recovery time, potential risk of vitamin deficiency, and risk for abdominal pain. For these reasons, there is a paramount need for other treatments for obesity and for food addiction. The current standard of care for obesity and food addiction is difficult to implement and lacks sustained efficacy. Most struggle to complete treatment, lose minimal weight, lack sustained weight loss, and engage in the well-known "YoYo" diet phenomenon. While bariatric surgery is currently the only effective treatment for obesity, there are several barriers associated with it such as eligibility requirements, invasiveness, difficult recovery, and cost making it not readily available for everyone. Some approved medications that help with obesity, such as orlistat, lorcaserin, or naltrexone-bupropion, have not been widely adopted by providers or patients due to their limited responses and adverse side effects. Probiotic cocktails have shown to be safe with little to no side effects. Preclinical models of probiotics demonstrate the ability to curb obesity in animal models. Therefore, a probiotic that is able to show significant weight loss along with lifestyle modifications would be highly adopted and desirable.

Will I have to stop taking my current medications?

You may need to stop taking medications that affect hunger, satiety, or appetite, as well as any on the medication exclusion list. However, if you are on maintenance medications and have been on a stable dose for 6 months, you may not need to stop them.

Are probiotics safe for humans?

Probiotics, including specific strains like Limosilactobacillus fermentum and Lactobacillus plantarum, have been studied in humans and are generally considered safe, with no serious adverse effects reported in clinical trials. ^{1 2 3 4 5}

How do probiotics differ from other treatments for obesity?

Probiotics for obesity are unique because they focus on altering the gut microbiota (the community of microorganisms in the digestive system) to potentially reduce body fat and weight, unlike traditional treatments that may focus on diet, exercise, or medication. Specific strains like Lactobacillus gasseri and Bifidobacterium spp. have shown promise in reducing abdominal fat and improving lipid profiles, offering a novel approach by targeting the gut's role in metabolism. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Probiotic, Beneficial bacteria, Live cultures, Microbial supplements for obesity?

Research shows that probiotics can lead to small reductions in body weight, BMI (a measure of body fat based on height and weight), and fat percentage in people with overweight or obesity. Probiotics may also improve gut health, which can help with weight loss by reducing inflammation and improving metabolism. ^{3 5 6 8 9}

Who Is on the Research Team?

Arpana Gupta, PhD

Principal Investigator

The Regents of the University of California, Los Angeles

Tien Dong, MD, PhD

Principal Investigator

The Regents of the University of California, Los Angeles

Are You a Good Fit for This Trial?

Adults aged 18-50 with a BMI of 25-40, who are not pregnant or nursing. Excluded if they have Type 1 diabetes, untreated thyroid disease, neurological issues, weigh over 400lbs, had certain abdominal surgeries, major medical conditions as determined by the study doctor, chronic pain or active psychiatric illness including eating disorders in the last two years.

Inclusion Criteria

BMI 25-40

Not Pregnant or Nursing

I am either male or female.

Exclusion Criteria

I am taking medication that affects my hunger or appetite.

I am not using birth control and may plan to get pregnant during the study.

I have not taken any antibiotics in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combination probiotic or placebo for 12 weeks

12 weeks

3 visits (in-person) at week 0, week 6, and week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Probiotic

Trial Overview This trial is testing whether probiotics can help people lose weight compared to a placebo. It's for those who find current obesity treatments ineffective and want to avoid bariatric surgery due to its risks and recovery time.

How Is the Trial Designed?

Group I: Probiotic Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

A systematic review of 15 randomized controlled trials involving 957 participants showed that probiotic supplementation led to small but significant reductions in body weight, BMI, and fat percentage in individuals with overweight or obesity.

The reductions in body weight were approximately 0.60 kg, BMI decreased by 0.27 kg/m², and fat percentage decreased by 0.60%, indicating that while probiotics can have a positive effect on weight management, the overall impact is modest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of probiotics on body weight, body mass index, fat mass and fat percentage in subjects with overweight or obesity: a systematic review and meta-analysis of randomized controlled trials. Borgeraas, H., Johnson, LK., Skattebu, J., et al.[2022]

Probiotic supplementation can positively alter the gut microbiota in obese individuals, which may help reduce gut permeability, inflammation, and metabolic disorders associated with obesity.

These changes in gut microbiota diversity and composition create a favorable environment for weight loss, suggesting that probiotics could be a beneficial strategy in managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss probiotic supplementation effect in overweight and obesity subjects: A review. Guazzelli Marques, C., de Piano Ganen, A., Zaccaro de Barros, A., et al.[2021]

Probiotic supplementation, particularly with Lactobacillus and Bifidobacterium, has shown promising antiobesity effects in animal models, including reductions in weight gain and fat tissue mass.

Human studies on probiotics for obesity management are limited, and more research is needed to determine their efficacy, as probiotic effects can vary significantly based on strain and individual factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Probiotics on the Microbiota: Effect on Obesity. Nova, E., Pérez de Heredia, F., Gómez-Martínez, S., et al.[2017]

In a study involving 36 male rats, supplementation with Bifidobacterium spp. significantly reduced body and fat weights, as well as harmful blood serum levels related to obesity, after 7 weeks on a high-fat diet.

The probiotics not only lowered levels of triglycerides and glucose but also increased beneficial gut bacteria, indicating their potential as a safe and effective intervention for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiobesity and lipid-lowering effects of Bifidobacterium spp. in high fat diet-induced obese rats. An, HM., Park, SY., Lee, DK., et al.[2023]

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]

Next-generation probiotics (NGPs) like Akkermansia muciniphila and Hafnia alvei show promise in treating obesity and related disorders, with mechanisms including improving gut health and reducing inflammation.

Initial studies in overweight and obese patients have shown encouraging results, but ongoing safety assessments and more extensive research are needed to fully understand their therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Next-Generation Probiotics in Obesity and Obesity-Associated Disorders: Current Knowledge and Future Perspectives. Vallianou, NG., Kounatidis, D., Tsilingiris, D., et al.[2023]

Manipulating gut microbiota through diet, antibiotics, or probiotics can influence the development of obesity, with certain Lactobacillus species linked to weight gain in both animals and humans.

Newborns and infants are especially vulnerable to the effects of antibiotics and probiotics, which may contribute to obesity later in life, highlighting the need for careful consideration in their use during early development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of the manipulation of the gut microbiota in obesity. Million, M., Raoult, D.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Effects of probiotics on body weight, body mass index, fat mass and fat percentage in subjects with overweight or obesity: a systematic review and meta-analysis of randomized controlled trials. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Weight loss probiotic supplementation effect in overweight and obesity subjects: A review. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The Role of Probiotics on the Microbiota: Effect on Obesity. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Antiobesity and lipid-lowering effects of Bifidobacterium spp. in high fat diet-induced obese rats. [2023]

5. Switzerland 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. [2022]

6. Switzerland 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Regulation of abdominal adiposity by probiotics (Lactobacillus gasseri SBT2055) in adults with obese tendencies in a randomized controlled trial. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of Next-Generation Probiotics in Obesity and Obesity-Associated Disorders: Current Knowledge and Future Perspectives. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The role of the manipulation of the gut microbiota in obesity. [2021]