100 Participants Needed

Probiotics for Obesity

AV
Overseen ByAllison Vaughan, MPH
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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.

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.12345

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.15678

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.34679

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.

Research Team

AG

Arpana Gupta, PhD

Principal Investigator

The Regents of the University of California, Los Angeles

TD

Tien Dong, MD, PhD

Principal Investigator

The Regents of the University of California, Los Angeles

Eligibility Criteria

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.
See 20 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: ProbioticActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

Findings from Research

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/mยฒ, and fat percentage decreased by 0.60%, indicating that while probiotics can have a positive effect on weight management, the overall impact is modest.
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.
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.
The Role of Probiotics on the Microbiota: Effect on Obesity.Nova, E., Pรฉrez de Heredia, F., Gรณmez-Martรญnez, S., et al.[2017]

References

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]
Weight loss probiotic supplementation effect in overweight and obesity subjects: A review. [2021]
The Role of Probiotics on the Microbiota: Effect on Obesity. [2017]
Antiobesity and lipid-lowering effects of Bifidobacterium spp. in high fat diet-induced obese rats. [2023]
Efficacy and Safety of Lactobacillus plantarum K50 on Lipids in Koreans With Obesity: A Randomized, Double-Blind Controlled Clinical Trial. [2022]
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]
Regulation of abdominal adiposity by probiotics (Lactobacillus gasseri SBT2055) in adults with obese tendencies in a randomized controlled trial. [2022]
The Role of Next-Generation Probiotics in Obesity and Obesity-Associated Disorders: Current Knowledge and Future Perspectives. [2023]
The role of the manipulation of the gut microbiota in obesity. [2021]
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