Probiotics for Obesity
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?
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
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a combination probiotic or placebo for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Probiotic
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor