NCT06030362 · University of California, Los Angeles
Probiotic Intervention Study
What this study is about
The current the usual treatment 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.
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
Probiotic
Dietary Supplement taken once daily for 3 months (90 days).
DIETARY_SUPPLEMENT
Placebo
Dietary Supplement taken once daily for 3 months (90days).
Primary outcome measures
Differences in metabolite concentrations pre & post intervention - Stool
Time frame: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (week 6), and once at the final 3month appointment (week 12).
Measurement of metabolomics via stool specimen.
Differences in metabolite concentrations pre & post intervention - Blood
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12).
Measurement of metabolomics via blood specimen.
Differences in microbiome levels pre & post intervention - Stool
Time frame: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (week 6), and once at the final 3month appointment (week 12).
16S RNA sequencing to measure microbiome levels via stool specimen.
Differences in microbiome levels pre & post intervention - Blood
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12).
16S RNA sequencing to measure microbiome levels via blood specimen.
Differences in microbiome levels pre & post intervention - Stool
Time frame: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (week 6), and once at the final 3month appointment (week 12).
Shotgun metagenomics, sequencing to measure microbiome levels via stool specimen.
Differences in microbiome levels pre & post intervention - Blood
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12).
Shotgun metagenomics, sequencing to measure microbiome levels via blood specimen.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male and Female
- Not Pregnant or Nursing
Exclusion criteria
- Co-morbidities including but not limited to:
- Type 1 (insulin dependent) diabetes
- vascular disease
- drastic weight loss (more than 10lbs over the preceding 2months)
- frequent strenuous exercise (i.e. marathon runners/heavy weight lifting)
- abdominal surgeries including weight loss surgery or partial/complete resection of stomach or bowel
- untreated thyroid disease
- neurological disease
- Major medical condition the PI/MD feels would put the subject at risk or interfere with data collection.
- Chronic pain
- 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.
- Using medications known to affect hunger/satiety/appetite
- 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.
- 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.
- Significant change in usual diet and/or weight loss of more than 10lbs in the last 2 months.
- Anyone taking medicines on the medication exclusion list.
- 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.).
Where
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations