NCT06030362Completed
Probiotic Intervention Study
Double Blinded Placebo Controlled Feasibility Study to Evaluate a Combination Probiotic in Adults With Obesity
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 106 (actual)
- First submitted
- 4 Aug 2023
- Start date
- 18 Jul 2023
- Primary completion date
- 19 Feb 2026
- Lead sponsor
- University of California, Los Angeles
- Diseases
- Obesity
- NCT number
- NCT06030362
What you commit to
- Study type: Interventional
- Participants enrolled: 106
- From 18 Jul 2023 to the primary completion date, 19 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- abdominal surgeries including weight loss surgery or partial/complete resection of stomach or bowel
- Using medications known to affect hunger/satiety/appetite
- Heavy use of alcohol and drugs will be determined by a positive endorsement on the MINI+. If the MINI+ is positive for alcohol or drug dependence or abuse, the participant will be excluded. In regards to tobacco use, participants will be excluded if they smoke more than 1/2 pack per day.
- Cannabis use will not be exclusionary. If the MINI+ is positive for drug dependence or abuse, the participant will be excluded.
- Anyone taking medicines on the medication exclusion list.
Other illness
- Type 1 (insulin dependent) diabetes
- vascular disease
- untreated thyroid disease
- neurological disease
- Major medical condition the PI/MD feels would put the subject at risk or interfere with data collection.
- Diagnosed DSM IV active psychiatric illness including eating disorders. Must not be active or present for at least 2 years. Participants with a positive endorsement on the MINI+ will be excluded.
Other
- Co-morbidities including but not limited to:
- drastic weight loss (more than 10lbs over the preceding 2months)
- frequent strenuous exercise (i.e. marathon runners/heavy weight lifting)
- Chronic pain
- Pregnant, lactating, postpartum less than 6months.
- Women of childbearing potential who are not practicing birth control or are planning to get pregnant during the study.
- Use of oral/IV antibiotics within the last 3 months
- Use of probiotics in the last 3 months.
- Significant change in usual diet and/or weight loss of more than 10lbs in the last 2 months.
- Non-English Speakers (due to the use of validated questionnaires and limited availability of translated copies, participants must be fluent in English so that they will be able to read and follow directions easily.
- Maintenance pharmacotherapies will not be exclusionary so long as they have been on a stable dose for 6months.
- Body weight at enrollment greater than 400lbs.
- Exclude from Optional MRI if: participant is unable to safely participate in the MRI (claustrophobia, presence of devices affected by MRI such as pacemakers, neurostimulators, metallic foreign bodies, etc.).
Who the study is looking for
- Ages 18-50
- BMI 25-40
- Male and Female
- Not Pregnant or Nursing
Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.